Covid 19 Clinical Trials

Report for D018352: Coronavirus Infections NIH

(Synonyms: Coronavirus Infect, Coronavirus Infections)

Developed by Shray Alag

Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation

Correlated Drug Terms (1264)

	Name (Synonyms)	Correlation
drug1822	Placebo Wiki	0.33
drug1086	Hydroxychloroquine Wiki	0.20
drug1853	Placebo oral tablet Wiki	0.14
drug2319	Standard of Care Wiki	0.13
drug1613	No intervention Wiki	0.11
drug1270	Ivermectin Wiki	0.11
drug2067	Remdesivir Wiki	0.11
drug1374	Losartan Wiki	0.10
drug1978	Questionnaire Wiki	0.09
drug2388	Survey Wiki	0.09
drug1598	Nitazoxanide Wiki	0.09
drug2662	Vitamin C Wiki	0.09
drug3018	survey Wiki	0.08
drug2715	Zinc Wiki	0.08
drug262	Azithromycin Wiki	0.08
drug2116	Ruxolitinib Wiki	0.08
drug923	Favipiravir Wiki	0.08
drug2663	Vitamin D Wiki	0.08
drug2326	Standard of care Wiki	0.08
drug2134	SARS-CoV-2 convalescent plasma Wiki	0.07
drug1863	Plasma Wiki	0.07
drug566	Chloroquine or Hydroxychloroquine Wiki	0.07
drug1612	No Intervention Wiki	0.07
drug2105	Rivaroxaban Wiki	0.07
drug1923	Prone positioning Wiki	0.07
drug3005	standard care Wiki	0.07
drug2763	blood donation SMS Wiki	0.07
drug1691	Online questionnaire Wiki	0.07
drug1860	Placebos Wiki	0.07
drug1103	Hydroxychloroquine Sulfate Wiki	0.07
drug2950	placebo Wiki	0.07
drug2314	Standard care Wiki	0.06
drug472	COVID-19 convalescent plasma Wiki	0.06
drug2465	Telerehabilitation Wiki	0.06
drug2739	anti-SARS-CoV-2 convalescent plasma Wiki	0.06
drug1687	Online Survey Wiki	0.06
drug1087	Hydroxychloroquine (HCQ) Wiki	0.06
drug1883	Povidone-Iodine Wiki	0.06
drug2787	convalescent plasma Wiki	0.06
drug2300	Standard Care Wiki	0.06
drug1604	Nitric Oxide Wiki	0.06
drug2527	Tocilizumab Wiki	0.06
drug1090	Hydroxychloroquine + azithromycin Wiki	0.06
drug2191	Sample collection Wiki	0.06
drug1890	Practice details Wiki	0.06
drug107	Acalabrutinib Wiki	0.06
drug1097	Hydroxychloroquine - Weekly Dosing Wiki	0.06
drug2047	Recombinant new coronavirus vaccine (CHO cells) placebo group Wiki	0.06
drug1022	HB-adMSCs Wiki	0.06
drug2046	Recombinant new coronavirus vaccine (CHO cells) high-dose group Wiki	0.06
drug431	CELLECTRA® 2000 Wiki	0.06
drug1376	Low Dose Radiation Therapy Wiki	0.06
drug2665	Vitamin Super B-Complex Wiki	0.06
drug2221	Selinexor Wiki	0.06
drug1462	Melatonin Wiki	0.06
drug1331	Leronlimab (700mg) Wiki	0.06
drug127	Aeonose Wiki	0.06
drug541	ChAdOx1 MERS Wiki	0.06
drug2039	Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Wiki	0.06
drug2045	Recombinant new coronavirus vaccine (CHO cell) low-dose group Wiki	0.06
drug1678	Olokizumab 64 mg Wiki	0.06
drug3048	vv-ECMO only (no cytokine adsorption) Wiki	0.06
drug2467	Telmisartan Wiki	0.06
drug1316	LY3819253 Wiki	0.06
drug1152	INO-4800 Wiki	0.06
drug2018	Radiation therapy Wiki	0.06
drug2114	Routine care for COVID-19 patients Wiki	0.06
drug2129	SARS-CoV-2 Wiki	0.06
drug2136	SARS-CoV-2 diagnostic rapid test Wiki	0.06
drug3047	vv-ECMO + cytokine adsorption (Cytosorb adsorber) Wiki	0.06
drug1023	HCQ Wiki	0.06
drug1952	Pulmozyme Wiki	0.06
drug1783	Peginterferon Lambda-1A Wiki	0.06
drug1998	REGN10933+REGN10987 combination therapy Wiki	0.06
drug1775	Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances Wiki	0.06
drug1595	Nigella Sativa / Black Cumin Wiki	0.06
drug2938	other Wiki	0.06
drug2986	retrospective analysis Wiki	0.06
drug2118	Ruxolitinib Oral Tablet Wiki	0.06
drug1279	Ivermectin Oral Product Wiki	0.06
drug542	ChAdOx1 nCoV-19 Wiki	0.06
drug2068	Remdesivir placebo Wiki	0.06
drug1566	Nafamostat Mesilate Wiki	0.06
drug601	Colchicine Wiki	0.06
drug1365	Lopinavir-Ritonavir Wiki	0.06
drug2121	SAB-185 Wiki	0.06
drug217	Aspirin Wiki	0.06
drug2880	mRNA-1273 Wiki	0.06
drug1115	Hydroxychloroquine Sulfate Tablets Wiki	0.06
drug2767	blood sampling Wiki	0.05
drug512	Camostat Mesilate Wiki	0.05
drug647	Convalescent Plasma Wiki	0.05
drug1372	Lopinavir/ritonavir Wiki	0.05
drug658	Convalescent plasma Wiki	0.05
drug491	COViage Wiki	0.05
drug1696	Opaganib Wiki	0.05
drug285	BCG vaccine Wiki	0.05
drug1911	Probiotic Wiki	0.05
drug1220	Interferon Beta-1B Wiki	0.05
drug1575	Nasopharyngeal swab Wiki	0.05
drug284	BCG Vaccine Wiki	0.05
drug1852	Placebo oral capsule Wiki	0.05
drug1606	Nitric Oxide Gas Wiki	0.05
drug1921	Prone position Wiki	0.05
drug1930	Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health Wiki	0.05
drug159	Anakinra Wiki	0.05
drug2176	Saline Wiki	0.05
drug315	Baricitinib Wiki	0.05
drug560	Chloroquine Wiki	0.04
drug1753	Pacebo: Calcium citrate Wiki	0.04
drug1011	Group B Control Wiki	0.04
drug1422	MVA-MERS-S_DF1 - Low Dose Wiki	0.04
drug1062	High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma Wiki	0.04
drug1977	Quercetin Treatment Wiki	0.04
drug1792	Performing of lung ultrasound Wiki	0.04
drug79	ASC09/ritonavir group Wiki	0.04
drug1548	NA-831and Dexamethasone Wiki	0.04
drug2777	chlorine dioxide 3000 ppm Wiki	0.04
drug2819	favipiravir Wiki	0.04
drug266	Azithromycin 500 milligram (mg) oral Tablet Wiki	0.04
drug2394	Surveys Wiki	0.04
drug1588	New QIAstat-Dx fully automatic multiple PCR detection platform Wiki	0.04
drug947	Fixed Anchoring Strategy Wiki	0.04
drug131	Aerosol-reducing Mask Wiki	0.04
drug1427	Maintenance or reduction of immunosuppression Wiki	0.04
drug667	CoronaCideTM COVID-19 IgM/IgG Rapid Test and Premier Biotech COVID-19 IgM/IgG Rapid Test Wiki	0.04
drug2143	SARS-CoV2 Infection Wiki	0.04
drug1567	Nafamostat Mesylate Wiki	0.04
drug65	ACT-541478 dose E1 Wiki	0.04
drug1158	IP-10 in CDS protocol Wiki	0.04
drug2166	SOC plus 15mg/kg EB05 IV Wiki	0.04
drug2835	home spirometry Wiki	0.04
drug1099	Hydroxychloroquine Only Product in Oral Dose Form Wiki	0.04
drug1278	Ivermectin Injectable Solution Wiki	0.04
drug2335	Standard screening strategy Wiki	0.04
drug1876	Point-of-care test for SARS-CoV-2 Wiki	0.04
drug316	Baricitinib (janus kinase inhibitor) Wiki	0.04
drug625	Comprehensive treatment Wiki	0.04
drug2725	a specifically designed self-administered questionnaire Wiki	0.04
drug2540	Toraymyxin PMX-20R (PMX Cartridge) Wiki	0.04
drug2874	lulizumab pegol Wiki	0.04
drug274	BAT Wiki	0.04
drug1219	Interferon Beta-1A Wiki	0.04
drug1246	Intramuscular Vaccine Wiki	0.04
drug1948	Pulmonary and Motor Rehabilitation Wiki	0.04
drug2752	bacTRL-Spike Wiki	0.04
drug1234	Internet-based self-help Wiki	0.04
drug3040	vaccine candidate MVA-MERS-S Wiki	0.04
drug2871	lopinavir/ritonavir Wiki	0.04
drug528	Carrimycin Wiki	0.04
drug1778	Patients admitted to Intensive Care Unit with SARS-CoV2 Wiki	0.04
drug1815	Physiological saline solution Wiki	0.04
drug2797	daily syndromic surveillance Wiki	0.04
drug2210	Self Supportive Care (SSC) Alone Wiki	0.04
drug1390	Low-dose Chest CT Wiki	0.04
drug1385	Low flow ECMO driving by CVVH machine Wiki	0.04
drug213	ArtemiC Wiki	0.04
drug1838	Placebo Vaccine Wiki	0.04
drug1443	Matrix-M Adjuvant Wiki	0.04
drug26	2019-nCoV PCR Wiki	0.04
drug279	BBV152A Wiki	0.04
drug1387	Low nitrite/NDMA meals Wiki	0.04
drug939	File scanning Wiki	0.04
drug2856	inhaled type I interferon Wiki	0.04
drug2631	Vehicle Control Wiki	0.04
drug1959	Q16 testing Wiki	0.04
drug39	38-questions questionnaire Wiki	0.04
drug2735	allogeneic human dental pulp stem cells (BSH BTC & Utooth BTC) Wiki	0.04
drug2623	Vaginal fluid Covid-19 PCR test Wiki	0.04
drug2780	cholecalciferol 50,000 IU Wiki	0.04
drug2794	current IPAC-UHN PPE Wiki	0.04
drug1018	Guided online support program Wiki	0.04
drug2566	Tuberculin test Wiki	0.04
drug2901	mouthrinse with bêta-cyclodextrin and citrox Wiki	0.04
drug1471	Merimepodib Wiki	0.04
drug1704	Organicell Flow Wiki	0.04
drug2412	TAK-671 Placebo Wiki	0.04
drug642	Control message Wiki	0.04
drug1477	Mesenchymal stem cells Wiki	0.04
drug1811	Physical Exercises Wiki	0.04
drug2569	Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule Wiki	0.04
drug1651	Not bravery message Wiki	0.04
drug624	Complex diagnostic panel Wiki	0.04
drug2338	Standard therapy Wiki	0.04
drug2490	The demographic, clinical, laboratory, and instrumental data Wiki	0.04
drug2721	Zithromax Oral Product Wiki	0.04
drug1181	Immunfluorescence Wiki	0.04
drug3031	tocilizumab Wiki	0.04
drug463	COVID-19 Pneumonia Wiki	0.04
drug293	BIOMARKERS IN THE LONG TERM IMPACT OF CORONAVIRUS INFECTION IN THE CARDIORRESPIRATORY SYSTEM Wiki	0.04
drug60	ACT-541478 10 mg Wiki	0.04
drug482	COVID-19 standard care Wiki	0.04
drug1110	Hydroxychloroquine Sulfate 400 mg twice a day Wiki	0.04
drug1885	Povidone-Iodine 0.5% Wiki	0.04
drug3034	transparent sheet Wiki	0.04
drug2864	laboratory biomarkers Wiki	0.04
drug718	Data Collection: Clinical Care Assessments Wiki	0.04
drug224	Assessment of Dietary Changes in Adults in the Quarantine Wiki	0.04
drug504	CVnCoV Vaccine Wiki	0.04
drug2001	RESP301, a Nitric Oxide generating solution Wiki	0.04
drug2057	Rehabilitation exercise protocol Wiki	0.04
drug618	Community interest message Wiki	0.04
drug1784	Peginterferon Lambda-1a Wiki	0.04
drug1558	NO intervention planned due to the observational study design - only a diagnostic testing Wiki	0.04
drug2026	Rapid Onsite COVID-19 Detection Wiki	0.04
drug2760	biological samples day of delivery Wiki	0.04
drug2949	pirfenidone Wiki	0.04
drug2815	exercise brochure Wiki	0.04
drug2981	recombinant human interferon Alpha-1b Wiki	0.04
drug2331	Standard of care therapy Wiki	0.04
drug2838	human cord tissue mesenchymal stromal cells Wiki	0.04
drug61	ACT-541478 100 mg Wiki	0.04
drug2509	Thoracic CT Scan Wiki	0.04
drug1737	PHR160 Spray Wiki	0.04
drug489	COVID19 vaccine Wiki	0.04
drug1989	Questionnaires for specific phobia Wiki	0.04
drug2225	SensiumVitals wearable sensor Wiki	0.04
drug2130	SARS-CoV-2 IgG Antibody Testing Kit Wiki	0.04
drug1848	Placebo of excipient(s) will be administered Wiki	0.04
drug2922	non-RAS blocking antihypertensives Wiki	0.04
drug1688	Online Survey about Dietary and Lifestyle Habits Wiki	0.04
drug612	Combination of Lopinavir /Ritonavir and Interferon beta-1b Wiki	0.04
drug1630	Non-Mindfulness intervention Wiki	0.04
drug1884	Povidone-Iodine (PVP-I) Wiki	0.04
drug2837	hospitalized children with Covid19 Wiki	0.04
drug2633	VentaProst (inhaled epoprostenol delivered via a dedicated delivery system) Wiki	0.04
drug1400	M201-A Injection Wiki	0.04
drug2541	Tracheostomy with aerosol box in COVID-19 positive patients Wiki	0.04
drug2892	mindfulness, emotion didactics, interpersonal skills, experiential learning Wiki	0.04
drug1322	Lactoferrin Wiki	0.04
drug1549	NETosis markers Wiki	0.04
drug1700	Oral 25-Hydroxyvitamin D3 Wiki	0.04
drug2124	SAR443122 Wiki	0.04
drug118	Active COVID-19 disease Wiki	0.04
drug967	Fourth Trimester Mobile Tool Wiki	0.04
drug931	Favipiravir Placebo Wiki	0.04
drug1615	No intervention - exposure is to COVID-19 Wiki	0.04
drug2368	Study Arm Wiki	0.04
drug1002	Glycine Wiki	0.04
drug2577	Two doses of placebo at the routine vaccination schedule Wiki	0.04
drug2650	Virtual Assistant first, then Human Coach Wiki	0.04
drug679	Covid-19 presto test Wiki	0.04
drug66	ACT-541478 high or low dose (or placebo) Wiki	0.04
drug1373	Lopinavir/ritonavir treatment Wiki	0.04
drug2556	Transplant patient Wiki	0.04
drug1945	Public space exposure Wiki	0.04
drug407	Bromhexine Hydrochloride Tablets Wiki	0.04
drug1888	Povidone-iodine Wiki	0.04
drug1463	Melatonin 2mg Wiki	0.04
drug1512	Monitoring Visit - Baseline Wiki	0.04
drug810	EIDD-2801 Wiki	0.04
drug178	Anluohuaxian Wiki	0.04
drug2167	SOC plus Placebo IV Wiki	0.04
drug1994	RBA-2 Wiki	0.04
drug2006	RS blend Wiki	0.04
drug2135	SARS-CoV-2 convalescent plasma treatment Wiki	0.04
drug2189	Sample Collection/Performance Evaluation (A) Wiki	0.04
drug1514	Monitoring Visit - Week 8 Wiki	0.04
drug2469	Telmisartan 40mg Wiki	0.04
drug2120	Ruxolitinib plus simvastatin Wiki	0.04
drug1116	Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets Wiki	0.04
drug938	File Scanning Wiki	0.04
drug546	ChAdOx1 nCoV-19 full boost Wiki	0.04
drug2444	Taste and olfactory function evaluation Wiki	0.04
drug549	ChAdox1 n-CoV-19 (Abs 260) vaccine low dose Wiki	0.04
drug1015	Group1 Wiki	0.04
drug429	CD24Fc Wiki	0.04
drug2886	media package Wiki	0.04
drug200	Any drug used to treat Covid-19 Wiki	0.04
drug1340	Liberase Enzyme (Roche) Wiki	0.04
drug1170	IgG antibodies immunoassay Wiki	0.04
drug1095	Hydroxychloroquine - Daily Dosing Wiki	0.04
drug508	Calcium Channel Blockers Wiki	0.04
drug2685	Web application users Wiki	0.04
drug831	Elective Cancer Surgery Wiki	0.04
drug2788	convalescent plasma application to SARS-CoV-2 infected patients Wiki	0.04
drug1093	Hydroxychloroquine + placebo Wiki	0.04
drug1699	Oral Wiki	0.04
drug2524	Titanium blood test Wiki	0.04
drug2961	pre_lunch Yoga-based breathing support Wiki	0.04
drug2611	Use of virus (Covid-19) genome sequence report to inform infection prevention control procedures Wiki	0.04
drug518	Candesartan Wiki	0.04
drug982	GX-19 Wiki	0.04
drug1263	Isoprinosine Wiki	0.04
drug1975	Quercetin Wiki	0.04
drug246	Auricular neuromodulation Wiki	0.04
drug979	GO2 PEEP MOUTHPIECE Wiki	0.04
drug2430	TJ003234 Wiki	0.04
drug214	Artemisinin / Artesunate Wiki	0.04
drug2825	further processing of health data Wiki	0.04
drug1877	Positive COVID Test Result - Hypothetical Scenario Wiki	0.04
drug2013	RT-PCR SARS-Cov2 Wiki	0.04
drug526	Caring Contacts Wiki	0.04
drug2138	SARS-CoV-2 plasma Wiki	0.04
drug1361	Lopinavir 200Mg/Ritonavir 50Mg FT Test Wiki	0.04
drug2542	Tracheotomy Wiki	0.04
drug2373	Study of immune-mediated mechanisms in patients tested positive for SARS-CoV-2 Wiki	0.04
drug2278	Social media & news consumption Wiki	0.04
drug1248	Intravenous Immune Globulin Wiki	0.04
drug2329	Standard of care management Wiki	0.04
drug1465	MenACWY Wiki	0.04
drug254	Aviptadil by intravenous infusion + standard of care Wiki	0.04
drug1446	McGrath videolaryngoscope Wiki	0.04
drug2420	TCC-COVID mHealth solution Wiki	0.04
drug856	Enoxaparin Higher Dose Wiki	0.04
drug466	COVID-19 Specific T Cell derived exosomes (CSTC-Exo) Wiki	0.04
drug1796	Peripheral blood sampling Wiki	0.04
drug963	Fondaparinux Wiki	0.04
drug2239	Serology Wiki	0.04
drug1528	Multifrequency Bioimpedance Spectroscopy Wiki	0.04
drug2812	evaluation of skin microvascular flow and reactivity Wiki	0.04
drug2990	risk factors Wiki	0.04
drug2576	Two doses of placebo at the emergency vaccination schedule Wiki	0.04
drug3024	telephone consult Wiki	0.04
drug2015	RTB101 Wiki	0.04
drug1272	Ivermectin + Doxycycline Wiki	0.04
drug2150	SCB-2019 with AS03 adjuvant Wiki	0.04
drug250	Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) Wiki	0.04
drug2123	SAMBA II (Diagnostic for the Real World) Wiki	0.04
drug2578	Two doses of placebo at the schedule of day 0,28 Wiki	0.04
drug1623	Non Intervention Wiki	0.04
drug2284	Spartan COVID-19 System Wiki	0.04
drug2327	Standard of care (SOC) Wiki	0.04
drug182	Anti-COVID-19 human immunoglobulin Wiki	0.04
drug1855	Placebo solution Wiki	0.04
drug11	0.9%NaCl Wiki	0.04
drug1532	Muscle ultrasound Wiki	0.04
drug2000	REGN3051 Wiki	0.04
drug2367	Study A Wiki	0.04
drug565	Chloroquine diphosphate Wiki	0.04
drug1151	INC424 / Ruxolitinib Wiki	0.04
drug2732	after-each-case room disinfection Wiki	0.04
drug2165	SOC + Placebo Wiki	0.04
drug1338	Levilimab Wiki	0.04
drug1809	Phsyiotherapy Wiki	0.04
drug2466	Telerehabilitation-Based Wiki	0.04
drug2164	SOC + Intravenous Famotidine Wiki	0.04
drug1619	No interventions planned Wiki	0.04
drug1666	Observational (registry) Wiki	0.04
drug130	Aerosol Box Wiki	0.04
drug1628	Non-Anchoring Strategy Control Wiki	0.04
drug2561	Treatment group: will receive a combination of Nitazoxanide, Ribavirin and Ivermectin for a duration of seven days : Wiki	0.04
drug152	Aluminum hydroxide Wiki	0.04
drug1563	NSS Saline Placebo Wiki	0.04
drug1599	Nitazoxanide 500 MG Wiki	0.04
drug1450	Medical Mask Wiki	0.04
drug176	Angiotensin receptor blocker Wiki	0.04
drug382	Blood sample for whole genome sequencing Wiki	0.04
drug1370	Lopinavir/Ritonavir 200 MG-50 MG Oral Tablet Wiki	0.04
drug247	Auto-questionnaires (patients co infected HIV Sras-CoV-2) Wiki	0.04
drug1819	Pioglitazone Wiki	0.04
drug2452	Teleconsultation either by phone or by computer consultation Wiki	0.04
drug2500	Therapeutic plasma exchange (TPE) Wiki	0.04
drug2231	Serologic testing Wiki	0.04
drug973	GAD-7 General anxiety disorder scale Wiki	0.04
drug170	Anger message Wiki	0.04
drug498	CT-V Wiki	0.04
drug1594	Nicotinamide riboside Wiki	0.04
drug1552	NHANES smell and taste tests Wiki	0.04
drug1392	Lower-dose prophylactic anticoagulation Wiki	0.04
drug1912	Probiotic and LC-PUFA Wiki	0.04
drug2411	TAK-671 Wiki	0.04
drug2350	Standard treatment for COVID-19 Wiki	0.04
drug2973	quesionnair Wiki	0.04
drug953	Flow cytometry Wiki	0.04
drug2943	patients COVID 19 Wiki	0.04
drug1576	Nasopharyngeal swab and main laboratory Wiki	0.04
drug256	Awake Proning Wiki	0.04
drug1211	Inhaled nitric oxide gas Wiki	0.04
drug109	Acalabrutinib Treatment B Wiki	0.04
drug2392	Survey and Questionnaire Wiki	0.04
drug2914	newborns from covid 19 positive mothers Wiki	0.04
drug1185	Immunological profiling Wiki	0.04
drug1639	Non-invasive ventilatory support Wiki	0.04
drug1637	Non-interventional study Wiki	0.04
drug2813	everolimus Wiki	0.04
drug149	Alteplase 100 MG [Activase] Wiki	0.04
drug2696	Withings ScanWatch Wiki	0.04
drug2101	Ritonavir Wiki	0.04
drug1899	Pregnant women under investigation for Coronavirus or diagnosed with COVID-19 Wiki	0.04
drug2934	online survey Wiki	0.04
drug1123	Hydroxychloroquine plus Nitazoxanide Wiki	0.04
drug1936	Psychiatric counseling Wiki	0.04
drug1873	Plitidepsin 2.5 mg/day Wiki	0.04
drug1275	Ivermectin 3Mg Tab Wiki	0.04
drug62	ACT-541478 1000 mg Wiki	0.04
drug215	Ascorbic Acid Wiki	0.04
drug1922	Prone position ventilation Wiki	0.04
drug2904	mycophenolate mofetil Wiki	0.04
drug2552	Transfusion of COVID-19 convalescent plasma Wiki	0.04
drug2215	Self-guided exercises Wiki	0.04
drug1125	Hydroxychloroquine sulfate Wiki	0.04
drug838	Embarrassment message Wiki	0.04
drug3009	standard operating procedures Wiki	0.04
drug27	25-OH cholecalciferol Wiki	0.04
drug1346	Linagliptin 5 MG Wiki	0.04
drug2218	Self-management booklet (SWitCh: Stay well during COVID-19) Wiki	0.04
drug7	0.9% Saline Wiki	0.04
drug1496	Mindfulness + Compassion Intervention (MC) Wiki	0.04
drug1100	Hydroxychloroquine Oral Product Wiki	0.04
drug1641	Normal (9%) Saline Wiki	0.04
drug2870	liposomal lactoferrin Wiki	0.04
drug832	Electric pad for human external pain therapy Wiki	0.04
drug2882	measurement of circulating sFlt1 concentration Wiki	0.04
drug1568	Naltrexone Wiki	0.04
drug2675	WFI water nebulization Wiki	0.04
drug2122	SAB-301 Wiki	0.04
drug930	Favipiravir Combined With Tocilizumab Wiki	0.04
drug443	COPAN swabbing and blood sample collection Wiki	0.04
drug281	BBV152C Wiki	0.04
drug1894	Prediction Market Wiki	0.04
drug2747	autologous adipose-derived stem cells Wiki	0.04
drug2236	Serological test for COVID-19. Wiki	0.04
drug606	Collection of Biological Samples Wiki	0.04
drug2983	regular care Wiki	0.04
drug2262	Simultaneous EGD and colonoscopy Wiki	0.04
drug2126	SARS-CoV Wiki	0.04
drug1868	Plasma from a volunteer donor Wiki	0.04
drug2240	Serology Test Wiki	0.04
drug2453	Telehealth Wiki	0.04
drug993	Gastrointestinal endoscopy Wiki	0.04
drug961	Follow-up at 14 days Wiki	0.04
drug1972	Quantitative analysis of SARS-CoV-2 antibodies Wiki	0.04
drug2464	Telephonic medical visit Wiki	0.04
drug412	Budesonide dry powder inhaler Wiki	0.04
drug2840	hydroxychloroquine Wiki	0.04
drug2315	Standard care delivered in the isolation hospitals. Wiki	0.04
drug140	Alferon LDO Wiki	0.04
drug1982	Questionnaire for evaluation of confinement on deviant sexual fantasies Wiki	0.04
drug1250	Intravenous Infusions of Stem Cells Wiki	0.04
drug1398	Lung impedance technique Wiki	0.04
drug2609	Use of mobile application Wiki	0.04
drug2178	Saline Nasal Irrigation Wiki	0.04
drug2086	Resveratrol Wiki	0.04
drug2423	TD139 Wiki	0.04
drug2573	Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule Wiki	0.04
drug650	Convalescent Plasma 1 Unit Wiki	0.04
drug1644	Normal Saline Infusion + standard of care Wiki	0.04
drug1774	Patient sampling Wiki	0.04
drug1165	Ibuprofen Wiki	0.04
drug183	Anti-SARS-CoV-2 Human Convalescent Plasma Wiki	0.04
drug2486	The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care: Wiki	0.04
drug628	Conestat alfa Wiki	0.04
drug1224	Interferon-Beta Wiki	0.04
drug1366	Lopinavir-Ritonavir Drug Combination Wiki	0.04
drug1633	Non-convalescent Plasma (control plasma) Wiki	0.04
drug1009	Group A HCQ Wiki	0.04
drug2163	SOC Wiki	0.04
drug2617	V-SARS Wiki	0.04
drug2543	Tradipitant Wiki	0.04
drug2408	T89 Wiki	0.04
drug2718	Zinc Gluconate Wiki	0.04
drug1339	Lianhua Qingwen Wiki	0.04
drug2796	daily room disinfection Wiki	0.04
drug2829	global survey Wiki	0.04
drug2229	Serial seroconversion measurements in hospital employees during the COVID-19 pandemic Wiki	0.04
drug2226	Sequencing Wiki	0.04
drug321	Base therapy Wiki	0.04
drug1900	Premier Biotech COVID-19 IgG/IgM Rapid test Cassette Wiki	0.04
drug2456	Telehealth monitoring Wiki	0.04
drug2544	Traditional Chinese Medicine Prescription Wiki	0.04
drug1474	Mesenchymal Stromal Cells infusion Wiki	0.04
drug1134	Hyperbaric Chamber Wiki	0.04
drug1031	HOME-CoV rule implementation Wiki	0.04
drug2906	mycophenolic acid Wiki	0.04
drug1551	NG test Wiki	0.04
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drug2755	belatacept Wiki	0.04
drug682	Crest Pro-Health Multi-Protection mouthwash Wiki	0.04
drug2591	Umbilical cord derived mesenchymal stem cells Wiki	0.04
drug192	Antibody test (SARS-CoV2) Wiki	0.04
drug1265	Isotonic saline 0.9% Wiki	0.04
drug2852	imaging, blood tests Wiki	0.04
drug2131	SARS-CoV-2 PCR Wiki	0.04
drug480	COVID-19 positive via testing Wiki	0.04
drug1602	Nitazoxanide and atazanavir/ritonavir Wiki	0.04
drug758	Diagnostic test Wiki	0.04
drug845	Emtricitabine/tenofovir disoproxil Wiki	0.04
drug1327	Learning running subcuticular sutures on the Gamified Educational Network Wiki	0.04
drug1516	Monitoring physiological data with the Hexoskin smart shirt Wiki	0.04
drug2051	Reference: Favipiravir 200 mg (Avigan) Wiki	0.04
drug2	(Standard of Care) SoC Wiki	0.04
drug1332	Let It Out (LIO)-C Wiki	0.04
drug2498	Therapeutic Plasma Exchange (TPE) Wiki	0.04
drug2774	care as usual Wiki	0.04
drug1607	Nitric Oxide delivered via LungFit™ system Wiki	0.04
drug181	Anti- SARS-CoV-2 Plasma Wiki	0.04
drug2589	Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care. Wiki	0.04
drug309	BVRS-GamVac-Combi Wiki	0.04
drug347	Biological collection (patients co infected HIV Sras-CoV-2) Wiki	0.04
drug2505	There is no intervention in this study Wiki	0.04
drug989	Garadacimab, Factor XIIa Antagonist Monoclonal Antibody Wiki	0.04
drug2372	Study Group Wiki	0.04
drug1617	No intervention, observational Wiki	0.04
drug1476	Mesenchymal cells Wiki	0.04
drug819	EUROIMMUN assay Wiki	0.04
drug2790	conventional management of patients Wiki	0.04
drug2855	indirect calorimetry Wiki	0.04
drug193	Antibody titration Wiki	0.04
drug445	COVICU Wiki	0.04
drug2369	Study B Wiki	0.04
drug537	Centricyte 1000 Wiki	0.04
drug666	Cordio App Wiki	0.04
drug1024	HCQ & AZ Wiki	0.04
drug822	Economic benefit message Wiki	0.04
drug2719	Zinc Sulfate Wiki	0.04
drug48	80 ppm Nitric Oxide delivered through LungFit Delivery System Wiki	0.04
drug2896	modified IPAC-UHN PPE Wiki	0.04
drug2547	Tramadol Wiki	0.04
drug2890	methylprednisolone Wiki	0.04
drug651	Convalescent Plasma 2 Units Wiki	0.04
drug545	ChAdOx1 nCoV-19 (qPCR) Wiki	0.04
drug1871	Plitidepsin 1.5 mg/day Wiki	0.04
drug1797	Personal Exercise Intervention Wiki	0.04
drug1973	Quantitative analysis of anti-SARS-CoV-2-antibodies Wiki	0.04
drug2778	chloroquine Wiki	0.04
drug2682	Wearing surgical face mask sprayed with hypertonic saline Wiki	0.04
drug1076	Human Coach first, then Virtual Assistant Wiki	0.04
drug2440	Taking biological samples Wiki	0.04
drug1616	No intervention / Evaluation of the ferritin and glycosylated ferritin by standard approved serological tests Wiki	0.04
drug1298	Ketogenic diet Wiki	0.04
drug575	Clarithromycin Wiki	0.04
drug1556	NK cells,IL15-NK cells,NKG2D CAR-NK cells,ACE2 CAR-NK cells,NKG2D-ACE2 CAR-NK cells Wiki	0.04
drug2382	Surgery Wiki	0.04
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drug1545	N95 respirator Wiki	0.04
drug995	General health education Wiki	0.04
drug1941	Psychological and physical rehabilitation based humanistic care Wiki	0.04
drug669	Coronavirus Disease 2019 Wiki	0.04
drug1197	Infliximab Wiki	0.04
drug2784	conjunctival RT PCR Wiki	0.04
drug2593	Unavailable COVID Test Result - Hypothetical Scenario Wiki	0.04
drug2987	rhDNase I Wiki	0.04
drug187	Anti-Sars-CoV-2 Convalescent Plasma Wiki	0.04
drug2139	SARS-CoV-2 questionnaire survey Wiki	0.04
drug659	Convalescent plasma (CP) Wiki	0.04
drug680	Covid-19 swab PCR test Wiki	0.04
drug1601	Nitazoxanide Tablets Wiki	0.04
drug1253	Intravenous saline injection (Placebo) Wiki	0.04
drug1755	Pacritinib Wiki	0.04
drug1780	Patients with the treatment agains COVID19 Wiki	0.04
drug2954	plasma from convalescent patients with COVID-19 Wiki	0.04
drug2768	blood sampling for biobank Wiki	0.04
drug2037	Recombinant Human Interferon α2b Spray Wiki	0.04
drug2936	oral nutrition supplement (ONS) enriched in eicosapentaenoic acid, gamma-linolenic acid and antioxidants Wiki	0.04
drug1999	REGN3048 Wiki	0.04
drug1676	Odd/Even birth year intervention groups Wiki	0.04
drug2956	plasma therapy using convalescent plasma with antibody against SARS-CoV-2 Wiki	0.04
drug1629	Non-Interventional Wiki	0.04
drug1203	Infusion placebo Wiki	0.04
drug1358	Lopinavir / ritonavir tablets combined with Xiyanping injection Wiki	0.04
drug1363	Lopinavir and Ritonavir Tablets Wiki	0.04
drug3013	standard treatment Wiki	0.04
drug2137	SARS-CoV-2 non-immune Plasma Wiki	0.04
drug228	Assessment of ventilator-associated pneumonia criteria Wiki	0.04
drug2656	Virtual Reality Pain Neuroscience Education Wiki	0.04
drug257	Awake proning Wiki	0.04
drug1124	Hydroxychloroquine plus standard preventive measures Wiki	0.04
drug188	Anti-coronavirus antibodies (immunoglobulins) obtained with DFPP form convalescent patients Wiki	0.04
drug1305	LAU-7b Wiki	0.04
drug1146	ID NOW vs. Accula Wiki	0.04
drug586	CloSYS mouthwash Wiki	0.04
drug657	Convalescent anti-SARS-CoV-2 plasma Wiki	0.04
drug2754	behavioral lifestyle intervention Wiki	0.04
drug1500	Mindfulness intervention Wiki	0.04
drug1771	Patient Navigation Program Wiki	0.04
drug2162	SNDX-6352 Wiki	0.04
drug775	Dipyridamole 100 Milligram(mg) Wiki	0.04
drug124	Additional biological samples Wiki	0.04
drug267	Azithromycin 500Mg Oral Tablet Wiki	0.04
drug2676	WHO recommendations (waiting condition) Wiki	0.04
drug1008	Group 2: control group with enoxaparin 40mg/d Wiki	0.04
drug2019	Radiological Detection Wiki	0.04
drug2421	TCM prescriptions Wiki	0.04
drug1360	Lopinavir 200Mg/Ritonavir 50Mg FT Reference Wiki	0.04
drug1889	Powered Air purifying respirator Wiki	0.04
drug2560	Treatment and prophylaxis Wiki	0.04
drug2049	Recombinase aided amplification (RAA) assay Wiki	0.04
drug110	Acalabrutinib Treatment C Wiki	0.04
drug799	Dutasteride Wiki	0.04
drug3023	telehealth applications Wiki	0.04
drug1509	Model validation Wiki	0.04
drug2532	Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 Wiki	0.04
drug2255	Sildenafil citrate tablets Wiki	0.04
drug1109	Hydroxychloroquine Sulfate 200 milligram (mg) Tab Wiki	0.04
drug1439	Matched Placebo Wiki	0.04
drug2268	Sirolimus 1 MG/ML Wiki	0.04
drug2907	nCapp, a cell phone-based auto-diagnosis system Wiki	0.04
drug1497	Mindfulness Alone (MO) Intervention Wiki	0.04
drug1646	Normal saline 0.9% Wiki	0.04
drug1631	Non-contact ECG Wiki	0.04
drug2690	Weekly Assessment Wiki	0.04
drug1321	Lactobaciltus rhamnosus GG Placebo Wiki	0.04
drug1540	N-Acetyl cysteine Wiki	0.04
drug1729	PD-1 blocking antibody+standard treatment Wiki	0.04
drug2974	questionaire to husband and wife Wiki	0.04
drug899	Extra blood sample Wiki	0.04
drug863	Environmental exposure and clinical features Wiki	0.04
drug2902	mouthrinse without bêta-cyclodextrin and citrox Wiki	0.04
drug547	ChAdOx1 nCoV-19 half boost Wiki	0.04
drug1315	LY3473329 Wiki	0.04
drug112	Access to training facility Wiki	0.04
drug2519	Tigerase® and best available care Wiki	0.04
drug554	Chest MRI Wiki	0.04
drug633	Continuation of ARB/ACEI Wiki	0.04
drug1710	Otilimab Wiki	0.04
drug1054	High Flow Nasal Oxygen (HFNO) Wiki	0.04
drug218	Aspirin 100mg Wiki	0.04
drug1527	MultiStem Wiki	0.04
drug2042	Recombinant human angiotensin-converting enzyme 2 (rhACE2) Wiki	0.04
drug1652	Novel laser inferometry test for CORONA virus Wiki	0.04
drug2850	iNO (inhaled nitric oxide) delivered via the INOpulse Delivery System Wiki	0.04
drug933	Favipiravir tablets Wiki	0.04
drug2940	oxygen treatment Wiki	0.04
drug1768	Pathogen-specific aAPC Wiki	0.04
drug561	Chloroquine Diphosphate Wiki	0.04
drug1077	Human biological samples Wiki	0.04
drug2525	To assess for development of IgG antibodies against SARS-CoV2 Wiki	0.04
drug2083	Respiratory rehabilitation Wiki	0.04
drug1281	Ivermectin Tablets Wiki	0.04
drug2204	Satisfaction evaluation Wiki	0.04
drug1421	MVA-MERS-S_DF1 - High Dose Wiki	0.04
drug2568	Two dose MenACWY vaccine 4-12 weeks Wiki	0.04
drug1367	Lopinavir/ Ritonavir Oral Tablet Wiki	0.04
drug2311	Standard Treatment Wiki	0.04
drug2862	isocaloric/isonutrigenous ONS Wiki	0.04
drug2844	hydroxychloroquine sulfate 200 MG Wiki	0.04
drug2217	Self-interest message Wiki	0.04
drug681	Covidfree@home Wiki	0.04
drug1854	Placebo plus standard preventive measures Wiki	0.04
drug1886	Povidone-Iodine 2% Wiki	0.04
drug1468	MenCare+/Bandebereho fathers'/couples' group education Wiki	0.04
drug1518	Montelukast 10mg Wiki	0.04
drug694	Cytokine Adsorption Wiki	0.04
drug1747	PT-Pal Wiki	0.04
drug1909	Primary care professionals reports of potential patient safety incidents, non-COVID-19 related Wiki	0.04
drug1537	N terminal pro B type natriuretic peptide (NTproBNP), D-Dimer, and serum Tropinin - I Wiki	0.04
drug2238	Serological tests will be applied on patients blood sampling Wiki	0.04
drug1082	Humanistic Care Wiki	0.04
drug543	ChAdOx1 nCoV-19 (Abs 260) Wiki	0.04
drug2260	Simulation Airway Coaching Wiki	0.04
drug557	Chinese Herbal Medicine Wiki	0.04
drug1483	Methylene Blue 5 MG/ML Wiki	0.04
drug1271	Ivermectin (IVM) Wiki	0.04
drug2847	hyperimmune plasma Wiki	0.04
drug1703	Oral-B Mouth Sore mouthwash Wiki	0.04
drug1530	Multivitamin Wiki	0.04
drug1345	Linagliptin Wiki	0.04
drug1176	Imaging by thoracic scanner Wiki	0.04
drug2649	Virtual ACT Workshop for Emotional Eating Wiki	0.04
drug2151	SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant Wiki	0.04
drug2643	Video based exercise Wiki	0.04
drug1957	Pyronaridine-Artesunate Wiki	0.04
drug965	Formulation without Active Drug Wiki	0.04
drug221	Assembled mask Wiki	0.04
drug100	Abatacept Wiki	0.04
drug1864	Plasma Donation Wiki	0.04
drug1118	Hydroxychloroquine and azithromycin treatment Wiki	0.04
drug781	Distilled water Wiki	0.04
drug793	Drug: Isotretinoin plus Tamoxifen Wiki	0.04
drug2814	exchange blood transfusion from normal donor Wiki	0.04
drug2704	Xiyanping injection Wiki	0.04
drug1094	Hydroxychloroquine , Sofosbuvir, daclatasvir Wiki	0.04
drug2201	Sarilumab SAR153191 Wiki	0.04
drug2432	TOF protocol Wiki	0.04
drug952	Flow controlled ventilation (Evone-ventilator) Wiki	0.04
drug2016	RTLS data Wiki	0.04
drug1432	Maraviroc Wiki	0.04
drug2323	Standard of Care (SOC) and Colchicine+Rosuvastatin Wiki	0.04
drug2625	Values Clarification and Attitudes Transformation (VCAT) Workshop Wiki	0.04
drug1814	Physical exercise Wiki	0.04
drug1357	Lopinavir / Ritonavir plus Ribavirin Wiki	0.04
drug524	Cardiac surgery Wiki	0.04
drug2468	Telmisartan 40Mg Oral Tablet Wiki	0.04
drug1919	Prone Positioning (PP) Wiki	0.04
drug2234	Serological screening for IgG and IgM antibodies against COVID-19 Wiki	0.04
drug2194	Sampling of tissue Wiki	0.04
drug2948	photobiomodulation and photodynamic therapy Wiki	0.04
drug2684	Web Based Survey Wiki	0.04
drug2756	bidirectional oxygenation mouthpiece Wiki	0.04
drug15	150 ppm Nitric Oxide delivered through LungFit Delivery System Wiki	0.04
drug1869	Platelet count, platelet, mean platelet volume and platelet distribution Width in COVID-19 Wiki	0.04
drug1218	Insulin regimen Wiki	0.04
drug115	Acetylsalicylic acid Wiki	0.04
drug1653	Nudge Wiki	0.04
drug2241	Serology for Covid-19 Wiki	0.04
drug1712	Oxidative Stress ELISA Kit Wiki	0.04
drug2244	Serum test Wiki	0.04
drug1944	Public Health England Gold Standard Wiki	0.04
drug409	Bromhexine and Spironolactone Wiki	0.04
drug2808	ensoETM device Wiki	0.04
drug1903	Prescription Opioid Management App Wiki	0.04
drug230	Association of diltiazem and niclosamide Wiki	0.04
drug77	ARBOX Wiki	0.04
drug825	Education sessions Wiki	0.04
drug2522	Tirofiban Injection Wiki	0.04
drug3026	this study is non- interventional Wiki	0.04
drug2565	Trust in science message Wiki	0.04
drug162	Anakinra 149 MG/ML Prefilled Syringe [Kineret] Wiki	0.04
drug358	Biomarkers expression Wiki	0.04
drug1578	Natural Honey Wiki	0.04
drug2400	Symptom and Exposure Surveys Wiki	0.04
drug2482	Thalidomide Wiki	0.04
drug1914	Progesterone 100 MG Wiki	0.04
drug2177	Saline Control Wiki	0.04
drug2839	hydrocortisone Wiki	0.04
drug1282	Ivermectin plus Nitazoxanide Wiki	0.04
drug865	Enzalutamide Pill Wiki	0.04
drug1403	MANAGEMENT OF COVID-19 Wiki	0.04
drug1801	Personalized Anchoring Strategy Wiki	0.04
drug968	Freestyle Libre 14 day CGM system Wiki	0.04
drug2942	pathogen reduced SARS-CoV-2 convalescent plasma Wiki	0.04
drug2495	The usual treatment Wiki	0.04
drug1757	Pamrevlumab Wiki	0.04
drug377	Blood sample Wiki	0.04
drug2187	Saliva collection Wiki	0.04
drug2612	Usual Care Wiki	0.04
drug2580	UC-MSCs Wiki	0.04
drug1399	Lung ultrasound Wiki	0.04
drug2197	Sarilumab Wiki	0.04
drug1645	Normal saline Wiki	0.04
drug2765	blood sample Wiki	0.03
drug2915	no intervention Wiki	0.03
drug636	Control Wiki	0.03
drug2753	basic treatment Wiki	0.03
drug1107	Hydroxychloroquine Sulfate 200 MG Wiki	0.03
drug451	COVID-19 Wiki	0.03
drug2192	Sampling Wiki	0.03
drug387	Blood test Wiki	0.03
drug1817	Physiotherapy Wiki	0.03
drug2595	Unfractionated heparin Wiki	0.03
drug2965	prone position Wiki	0.03
drug208	Arbidol Wiki	0.03
drug2183	Saline solution Wiki	0.03
drug804	ECG Wiki	0.03
drug1570	Nasal swab Wiki	0.03
drug374	Blood draw Wiki	0.03
drug1795	Peripheral blood draw Wiki	0.03
drug2499	Therapeutic anticoagulation Wiki	0.03
drug1642	Normal Saline Wiki	0.03
drug1478	Mesenchymal stromal cells Wiki	0.03
drug835	Electronic questionnaire Wiki	0.03
drug305	BNT162b2 Wiki	0.03
drug1442	Matching placebo Wiki	0.03
drug2263	Simvastatin Wiki	0.03
drug1592	Niclosamide Wiki	0.03
drug1828	Placebo Administration Wiki	0.03
drug1887	Povidone-Iodine Nasal Spray and Gargle Wiki	0.03
drug2265	Single Dose of Hydroxychloroquine Wiki	0.03
drug1178	Imatinib Wiki	0.03
drug821	Echocardiography Wiki	0.03
drug465	COVID-19 Serology Wiki	0.03
drug1738	PLACEBO Wiki	0.03
drug1098	Hydroxychloroquine 200 Mg Oral Tablet Wiki	0.03
drug1893	Prazosin Wiki	0.03
drug2332	Standard of care treatment Wiki	0.03
drug2062	Relatlimab Wiki	0.03
drug1114	Hydroxychloroquine Sulfate Regular dose Wiki	0.03
drug1788	Pentoxifylline Wiki	0.03
drug1401	M5049 Wiki	0.03
drug563	Chloroquine Sulfate Wiki	0.03
drug649	Convalescent Plasma (anti-SARS-CoV-2 plasma) Wiki	0.03
drug2976	questionnaire Wiki	0.03
drug2235	Serological test Wiki	0.03
drug1561	NORS (Nitric Oxide Releasing Solution) Wiki	0.03
drug1303	L-ascorbic acid Wiki	0.03
drug1117	Hydroxychloroquine and Azithromycin Wiki	0.03
drug726	Data record Wiki	0.03
drug2092	Ribavirin Wiki	0.03
drug1979	Questionnaire Administration Wiki	0.03
drug824	Eculizumab Wiki	0.03
drug2964	pregnant women with laboratory-confirmed 2019-n-CoV Wiki	0.03
drug349	Biological sample collection Wiki	0.03
drug1089	Hydroxychloroquine + Azithromycin Wiki	0.03
drug1618	No intervention, observational study Wiki	0.03
drug1485	Methylprednisolone Sodium Succinate Wiki	0.03
drug343	Bevacizumab Injection Wiki	0.03
drug2271	SivoMixx (200 billion) Wiki	0.03
drug588	Clopidogrel Wiki	0.03
drug1258	Iodine Complex Wiki	0.03
drug2389	Survey Administration Wiki	0.03
drug2528	Tocilizumab (TCZ) Wiki	0.03
drug670	Corticosteroid Wiki	0.03
drug304	BNT162b1 Wiki	0.03
drug1113	Hydroxychloroquine Sulfate Loading Dose Wiki	0.03
drug1163	Ibrutinib Wiki	0.03
drug2539	Tofacitinib 10 mg Wiki	0.03
drug2766	blood samples Wiki	0.03
drug1441	Matching Placebo Wiki	0.03
drug1541	N-acetylcysteine Wiki	0.03
drug1610	Nivolumab Wiki	0.02
drug748	Dexamethasone Wiki	0.02
drug2069	Remestemcel-L Wiki	0.02
drug2994	self-administered questionnaire Wiki	0.02
drug2413	TAK-788 Wiki	0.02
drug2196	Sargramostim Wiki	0.02
drug1108	Hydroxychloroquine Sulfate 200 MG [Plaquenil] Wiki	0.02
drug2276	SnPP Protoporphyrin plus Sunlight exposure Wiki	0.02
drug332	Best Practice Wiki	0.02
drug1368	Lopinavir/Ritonavir Wiki	0.02
drug2930	observational Wiki	0.02
drug3012	standard therapy Wiki	0.02
drug1693	Online survey Wiki	0.02
drug2321	Standard of Care (SOC) Wiki	0.02
drug719	Data collection Wiki	0.02
drug1715	Oxygen Wiki	0.02
drug53	ACE inhibitor Wiki	0.02
drug1470	Mepolizumab Wiki	0.02
drug1355	Lopinavir / Ritonavir Wiki	0.02
drug1481	Methotrexate Wiki	0.02
drug2078	Reslizumab Wiki	0.02
drug791	Doxycycline Wiki	0.02
drug2664	Vitamin D3 Wiki	0.02
drug1083	Hydrocortisone Wiki	0.02
drug576	Clazakizumab Wiki	0.02
drug454	COVID-19 Convalescent Plasma Wiki	0.02
drug1898	Prednisone Wiki	0.02
drug2348	Standard treatment Wiki	0.02
drug1484	Methylprednisolone Wiki	0.01

Correlated MeSH Terms (127)

	Name (Synonyms)	Correlation
D045169	Severe Acute Respiratory Syndrome NIH	0.82
D007239	Infection NIH	0.28
D003141	Communicable Diseases NIH	0.27
D011014	Pneumonia NIH	0.18
D013577	Syndrome NIH	0.16
D014777	Virus Diseases NIH	0.13
D012128	Respiratory Distress Syndrome, Adult NIH	0.13
D012127	Respiratory Distress Syndrome, Newborn NIH	0.13
D011024	Pneumonia, Viral NIH	0.12
D055371	Acute Lung Injury NIH	0.11
D003333	Coronaviridae Infections NIH	0.08
D012327	RNA Virus Infections NIH	0.06
D012141	Respiratory Tract Infections NIH	0.06
D058070	Asymptomatic Diseases NIH	0.06
D016638	Critical Illness NIH	0.05
D011665	Pulmonary Valve Insufficiency NIH	0.05
D012140	Respiratory Tract Diseases NIH	0.05
D004408	Dysgeusia NIH	0.05
D003428	Cross Infection NIH	0.05
D016769	Embolism and Thrombosis NIH	0.05
D008171	Lung Diseases, NIH	0.04
D030341	Nidovirales Infections NIH	0.04
D001997	Bronchopulmonary Dysplasia NIH	0.04
D008595	Menorrhagia NIH	0.04
D008659	Metabolic Diseases NIH	0.04
D006929	Hyperaldosteronism NIH	0.04
D014552	Urinary Tract Infections NIH	0.04
D011470	Prostatic Hyperplasia NIH	0.04
D012772	Shock, Septic NIH	0.04
D054559	Hyperphosphatemia NIH	0.04
D019446	Endotoxemia NIH	0.04
D007410	Intestinal Diseases NIH	0.04
D006965	Hyperplasia NIH	0.04
D004314	Down Syndrome NIH	0.04
D011565	Psoriasis NIH	0.04
D009220	Myositis NIH	0.04
D000073436	Microvascular Rarefaction NIH	0.04
D014786	Vision Disorders NIH	0.04
D011649	Pulmonary Alveolar Proteinosis NIH	0.04
D018376	Cardiovascular Abnormalities NIH	0.04
D063806	Myalgia NIH	0.04
D018410	Pneumonia, Bacterial NIH	0.04
D006402	Hematologic Diseases NIH	0.04
D015354	Vision, Low NIH	0.04
D003384	Coxsackievirus Infections NIH	0.04
D000370	Ageusia NIH	0.04
D004700	Endocrine System Diseases NIH	0.04
D054990	Idiopathic Pulmonary Fibrosis NIH	0.04
D000309	Adrenal Insufficiency NIH	0.04
D007008	Hypokalemia NIH	0.04
D010608	Pharyngeal Diseases NIH	0.04
D055501	Macrophage Activation Syndrome NIH	0.04
D007049	Iatrogenic Disease NIH	0.04
D044882	Glucose Metabolism Disorders NIH	0.04
D008173	Lung Diseases, Obstructive NIH	0.04
D003920	Diabetes Mellitus, NIH	0.04
D000860	Hypoxia NIH	0.04
D003289	Convalescence NIH	0.04
D000857	Olfaction Disorders NIH	0.04
D012120	Respiration Disorders NIH	0.04
D055370	Lung Injury NIH	0.03
D003924	Diabetes Mellitus, Type 2 NIH	0.03
D013923	Thromboembolism NIH	0.03
D007249	Inflammation NIH	0.03
D000066553	Problem Behavior NIH	0.03
D054556	Venous Thromboembolism NIH	0.03
D004417	Dyspnea NIH	0.03
D009205	Myocarditis NIH	0.03
D058186	Acute Kidney Injury NIH	0.03
D000505	Alopecia NIH	0.03
D029424	Pulmonary Disease, Chronic Obstructive NIH	0.03
D009080	Mucocutaneous Lymph Node Syndrome NIH	0.03
D000075902	Clinical Deterioration NIH	0.03
D003139	Common Cold NIH	0.03
D006330	Heart Defects, Congenital NIH	0.03
D000257	Adenoviridae Infections NIH	0.03
D000208	Acute Disease NIH	0.03
D006470	Hemorrhage NIH	0.03
D019851	Thrombophilia NIH	0.03
D060085	Coinfection NIH	0.03
D007040	Hypoventilation NIH	0.03
D013927	Thrombosis NIH	0.03
D053717	Pneumonia, Ventilator-Associated NIH	0.03
D020141	Hemostatic Disorders NIH	0.02
D007251	Influenza, Human NIH	0.02
D004617	Embolism NIH	0.02
D001778	Blood Coagulation Disorders NIH	0.02
D009102	Multiple Organ Failure NIH	0.02
D018184	Paramyxoviridae Infections NIH	0.02
D000163	Acquired Immunodeficiency Syndrome NIH	0.02
D009461	Neurologic Manifestations NIH	0.02
D006973	Hypertension NIH	0.02
D018450	Disease Progression NIH	0.02
D012818	Signs and Symptoms, Respiratory NIH	0.02
D001289	Attention Deficit Disorder with Hyperactivity NIH	0.02
D011618	Psychotic Disorders NIH	0.02
D006331	Heart Diseases NIH	0.02
D015212	Inflammatory Bowel Diseases NIH	0.02
D003327	Coronary Disease NIH	0.02
D008175	Lung Neoplasms NIH	0.02
D003863	Depression, NIH	0.02
D018805	Sepsis NIH	0.02
D011658	Pulmonary Fibrosis NIH	0.02
D014808	Vitamin D Deficiency NIH	0.02
D001523	Mental Disorders NIH	0.02
D009765	Obesity NIH	0.02
D015658	HIV Infections NIH	0.02
D011248	Pregnancy Complications NIH	0.02
D007153	Immunologic Deficiency Syndromes NIH	0.02
D007154	Immune System Diseases NIH	0.02
D012769	Shock, NIH	0.02
D013313	Stress Disorders, Post-Traumatic NIH	0.02
D018357	Respiratory Syncytial Virus Infections NIH	0.02
D053120	Respiratory Aspiration NIH	0.02
D019337	Hematologic Neoplasms NIH	0.02
D006333	Heart Failure NIH	0.02
D020246	Venous Thrombosis NIH	0.01
D017563	Lung Diseases, Interstitial NIH	0.01
D020521	Stroke NIH	0.01
D011655	Pulmonary Embolism NIH	0.01
D040921	Stress Disorders, Traumatic NIH	0.01
D009369	Neoplasms, NIH	0.01
D014947	Wounds and Injuries NIH	0.01
D002318	Cardiovascular Diseases NIH	0.01
D004630	Emergencies NIH	0.01
D004194	Disease NIH	0.01
D001008	Anxiety Disorders NIH	0.01

Correlated HPO Terms (54)

	Name (Synonyms)	Correlation
HP:0002090	Pneumonia HPO	0.18
HP:0011947	Respiratory tract infection HPO	0.06
HP:0010444	Pulmonary insufficiency HPO	0.05
HP:0002088	Abnormal lung morphology HPO	0.04
HP:0002905	Hyperphosphatemia HPO	0.04
HP:0003765	Psoriasiform dermatitis HPO	0.04
HP:0001871	Abnormality of blood and blood-forming tissues HPO	0.04
HP:0002900	Hypokalemia HPO	0.04
HP:0000846	Adrenal insufficiency HPO	0.04
HP:0000505	Visual impairment HPO	0.04
HP:0008711	Benign prostatic hyperplasia HPO	0.04
HP:0000132	Menorrhagia HPO	0.04
HP:0003326	Myalgia HPO	0.04
HP:0000224	Hypogeusia HPO	0.04
HP:0000818	Abnormality of the endocrine system HPO	0.04
HP:0100614	Myositis HPO	0.04
HP:0002242	Abnormal intestine morphology HPO	0.04
HP:0012047	Hemeralopia HPO	0.04
HP:0006517	Intraalveolar phospholipid accumulation HPO	0.04
HP:0000859	Hyperaldosteronism HPO	0.04
HP:0006536	Pulmonary obstruction HPO	0.04
HP:0001907	Thromboembolism HPO	0.04
HP:0000819	Diabetes mellitus HPO	0.04
HP:0012418	Hypoxemia HPO	0.04
HP:0000458	Anosmia HPO	0.04
HP:0005978	Type II diabetes mellitus HPO	0.03
HP:0012819	Myocarditis HPO	0.03
HP:0000708	Behavioral abnormality HPO	0.03
HP:0002098	Respiratory distress HPO	0.03
HP:0001919	Acute kidney injury HPO	0.03
HP:0002791	Hypoventilation HPO	0.03
HP:0100724	Hypercoagulability HPO	0.03
HP:0001627	Abnormal heart morphology HPO	0.03
HP:0002293	Alopecia of scalp HPO	0.03
HP:0006510	Chronic pulmonary obstruction HPO	0.03
HP:0001928	Abnormality of coagulation HPO	0.02
HP:0000822	Hypertension HPO	0.02
HP:0002037	Inflammation of the large intestine HPO	0.02
HP:0000709	Psychosis HPO	0.02
HP:0007018	Attention deficit hyperactivity disorder HPO	0.02
HP:0100526	Neoplasm of the lung HPO	0.02
HP:0100806	Sepsis HPO	0.02
HP:0002206	Pulmonary fibrosis HPO	0.02
HP:0100512	Low levels of vitamin D HPO	0.02
HP:0001626	Abnormality of the cardiovascular system HPO	0.02
HP:0002721	Immunodeficiency HPO	0.02
HP:0001513	Obesity HPO	0.02
HP:0001635	Congestive heart failure HPO	0.02
HP:0002625	Deep venous thrombosis HPO	0.01
HP:0006515	Interstitial pneumonitis HPO	0.01
HP:0001297	Stroke HPO	0.01
HP:0002204	Pulmonary embolism HPO	0.01
HP:0001909	Leukemia HPO	0.01
HP:0002664	Neoplasm HPO	0.01

There are 596 clinical trials

Clinical Trials

1 An Investigation of the Inflammatory Response in Severe Acute Respiratory Syndrome (SARS)

Severe Acute Respiratory Syndrome (SARS) is a newly recognized illness that can be fatal. The purpose of this study is to better understand SARS by collecting samples of blood and other body fluids of people who have been exposed to SARS or who are suspected to have the illness. Up to 300 volunteers aged 18 years or older will be enrolled in this study. Participants will donate blood samples and, if appropriate, samples of fluid from the lungs, nose, or throat. Researchers will test these samples for proteins that control or mediate inflammatory or immune responses. The patterns of these proteins will reveal how SARS affects the body and the efforts the body makes to fight off the infection.

NCT00066209 SARS Virus

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

2 Clinical Evaluation and Management of Persons With Severe Acute Respiratory Syndrome (SARS)

This study will evaluate and treat people with SARS, a new type of pneumonia (lung infection) originating in China. SARS is caused by a new virus that is easily transmitted from person to person. This study will look at the course of the disease; determine how the virus affects the body and how the body fights the infection; and evaluate diagnostic tests to quickly identify the disease. People 18 years of age and older with probable or suspected SARS may be eligible for this study. Close contacts of patients with SARS, patients who recovered from SARS, and NIH health care workers involved in the care of patients will also be enrolled. Patients with SARS who require hospitalization will be admitted to the NIH Clinical Center. Because SARS spreads easily, hospitalized patients will be in a room by themselves and will not be allowed any visitors. They will not leave their room except for tests, such as x-rays. All participants will have a full medical examination, including a medical history, physical examination, and blood tests. In addition, the participants undergo various tests and procedures as follows: - Probable and suspected SARS patients may be hospitalized or may be seen as outpatients. They are provided the treatment judged best for their disease, usually according to expressed or published recommendations. The best treatment for SARS is not yet known, and there have been no studies evaluating therapies. Outpatients are seen three times a week for 2 weeks, once a week for 4 more weeks, and then at 6 months. Patients have mouth and throat swabs taken three times a week for the first 2 weeks, then once a week for 4 more weeks. Blood is drawn three times a week for the first 2 weeks, then once at weeks 3, 4, and 6. If virus is still detectable after 6 weeks, nose washings and throat swabs are repeated until no virus is detected for 3 weeks in a row. In addition, patients provide urine and stool samples, have a chest x-ray and electrocardiogram, and undergo bronchoscopy and bronchial lavage. For the bronchoscopy, a bronchoscope (pencil-thin flexible tube) is passed into the large airways of the lung, allowing the physician to examine the airways. Cells and secretions from the airways are rinsed from the lung with salt water. A brush the size of a pencil tip is passed through the bronchoscope to scrape cells lining the airways and pieces of tissue are collected for analysis. - Close contacts of patients are evaluated twice a week for 2 weeks, then once a week for 2 more weeks. Blood is drawn at the first visit and then at 1, 2, and 4 weeks. Mouth and throat swabs, nose washings, and sputum collections are done twice a week for 2 weeks, then once a week for 2 more weeks. Urine and stool samples are collected once a week for 4 weeks. If virus from the nose or throat is still detectable after 4 weeks, weekly nose washings and throat swabs continue until no virus is detected for 3 weeks in a row. Blood may also be drawn during the weekly visits. - Recovered SARS patients provide blood, urine, and stool samples and have a mouth and throat swab and nose aspiration to see if the SARS virus is present. For the nasal aspiration, salt water is put in the nose and then suctioned out. Usually, these tests are done only once. If virus is detected, however, the nose washing, throat swabs and blood tests are repeated once a week until no virus is detected for 3 weeks in a row. - Health care workers document their contact with patients, use of isolation procedures and equipment, and any unexpected events that occur during contact. They are evaluated for symptoms of infection and provide a blood sample once a month

NCT00073086 Severe Acute Respiratory Syndrome

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Syndrome

3 Contamination During Removal of Two Different Personal Protective Systems When Working Under Conditions Requiring Enhanced Respiratory and Contact Precautions

Highly communicable and virulent diseases, the ongoing threat of emerging infectious diseases, and the prospect of bio-terrorism have become part of the new reality for health care workers. SARS transmission has occurred despite the use of droplet, contact, and airborne precautions. Potential explanations for some of the episodes of “through-precautions” transmission include the possibility of contamination during removal of protective clothing. The recommended protective systems (PPS) for aerosol generating procedures set out by the US Center for Disease Control and Prevention (CDC) and the Ontario Ministry of Health and Long Term Care (MOHLTC) differ. The failure of a PPS may be associated with significant consequences in terms of the morbidity and mortality of front-line health care workers. The purpose of this study is to determine if a difference exists between the rate of self-contamination due to deficiencies in contact precautions for individuals wearing either the CDC or MOHLTC recommended PPS. Study participants will don one of the two recommended PPS, be “contaminated” with an indicator that becomes visible under ultraviolet light, and then assessed for contamination of clothing layers and skin after removal of the PPS. They will then repeat the procedure using the other PPS.

NCT00150475 Severe Acute Respiratory Syndrome Procedure: Powered Air purifying respirator

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Measure: The primary endpoint of this study is the presence of any detected

Measure: base clothing layer, skin, or hair contamination.

Secondary Outcomes

Measure: The secondary endpoints: 1) contamination episodes of any layer, and 2) protective

Measure: system donning and removal procedure violations

4 The Interaction Between Severe Acute Respiratory Distress Syndrome Viral Proteins and Monocytes

Severe acute respiratory syndrome (SARS) is a new threat to public health since November, 2002. The SARS is highly contagious and is believed to be transmitted by person-to-person through droplet and direct contact. The patients present with fever, chills, cough, myalgia, dyspnea, and diarrhea. The symptoms aggravate in the second week and nearly 40% of the patients develop respiratory failure that requires assisted ventilation. The mortality rate is reported as 6.5%-7%. After several months, the world scientists found the etiology to be a new coronavirus not belonging to the previous coronavirus group I, II and III. The new virus is called SARS associated coronavirus (SARS-CoV). Although the high morbidity and mortality of SARS occurred in adults, there was rare mortality reported in the children. The report from Hong Kong pointed out that the symptoms of SARS in younger children were milder and the clinical course was not as aggressive as in adults. Therefore, the aim of the project is to design the experiment to see the differences of immunological responses to SARS-CoV protein in healthy younger children, teenagers, and adults. The investigators hope that the result could explain the reason for milder disease in younger children and the immunological pathogenesis of SARS.

NCT00172263 Severe Acute Respiratory Syndrome Procedure: blood sampling

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Syndrome

5 A Randomized, Dose-ranging Study of Alferon® LDO {Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)} in Normal Volunteers and/or Asymptomatic Subjects With Exposure to a Person Known to Have SARS or Possible SARS

The purpose of this trial is to conduct a randomized dose-ranging study to evaluate the safety and activity of orally administered low dose interferon alfa-n3 as an antiviral and immunomodulator in asymptomatic subjects with recent exposure to a person with severe acute respiratory syndrome (SARS) or possible SARS. The primary objective of this pilot study is to determine an Alferon LDO dose level that increases or upregulates genes known to be mediators of interferon response. Secondary endpoints include the development of SARS symptomatology, rate of hospitalization, and mortality rate. In the event that no subjects with recent exposure to a person with SARS or possible SARS are available, this study will be conducted with 10 normal volunteers.

NCT00215826 Severe Acute Respiratory Syndrome Drug: Alferon LDO

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: Increased expression of genes known to be mediators of interferon response.

Measure: Gene expression analysis

Time: Days 0, 2, 6, 11, 12, 15, 20 and 40

Secondary Outcomes

Description: Development of clinical SARS-CoV symptomatology

Measure: SARS CoV Antibody

Time: Days 0, 15, 20 and 40

Description: Hospitalization for SARS-CoV infection and Death

Measure: SARS-CoV infection

6 Collection of Convalescent SARS Plasma by Apheresis

The purpose of this study is to collect plasma by apheresis from patients who have recovered from Severe Acute Respiratory Syndrome (SARS). This plasma will be processed into a SARS-antibody enriched intravenous immune globulin (IVIG) product. This product will then be available for use in a clinical trial if a SARS epidemic recurs. Potentially eligible participants are people between 18 and 56 years of age who have recovered from SARS. Potential participants will undergo three sequential screenings to determine their eligibility for this study. Eligible participants will then be scheduled for plasmapheresis. After apheresis, additional testing will be performed on a sample of the source plasma. Once the sample has been tested and cleared, the source plasma will be shipped to the United States to the storage facility and finally to the site of manufacturing of the IVIG product. Participants may donate plasma again after 14 days. The study will not have a direct benefit for participants. However, participation may help develop a treatment that could be useful to other people who become infected with SARS.

NCT00342524 Severe Acute Respiratory Syndrome SARS

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

7 Immune Responses, Transmission and Nucleotide Polymorphisms in Families With SARS Virus Infections

The purpose of this study is to understand how severe acute respiratory syndrome (SARS) spreads within families, if significant disease resulted, and how the body responds to SARS. The study will also explore the affects of SARS on genetics and the immune system (the body system that fights disease). Up to 1000 people residing in Beijing, China may be involved in this study. Adult survivors of SARS (numbering 200) and their family members including children age 4 and up will be asked to participate in the study. The study will recruit an additional 200 persons, who will be matched with SARs survivors of similar age, gender, health status, and housing/work location, and recruited as comparators. Blood will be taken from all volunteers and tested for the presence of SARS antibodies (proteins made by the body's immune system in response to something that can cause infection). Health and clinic/hospital visit records may be reviewed.

NCT00523276 Coronavirus (SARS-CoV)

MeSH:Coronavirus Infections

Primary Outcomes

Measure: Positive serology, SARS CoV

Time: at time of assay

8 Phase I, Double-Blinded, Placebo-Controlled Dosage Escalation Study of the Safety and Immunogenicity of Adjuvanted and Non-Adjuvanted Inactivated SARS Coronavirus (SARS-CoV) Vaccine Administered by the Intramuscular Route

Severe acute respiratory syndrome (SARS) is a viral illness that affects the respiratory (breathing) system. The purpose of this study is to evaluate the safety and protective (immune) responses to different doses of a SARS vaccine given with or without an adjuvant. An adjuvant is a substance that may be added to a vaccine to improve the immune response so that less of the vaccine may need to be given. Study participants will include 72 volunteers, ages 18-40, living in the Houston, Texas area. The study will take place at Baylor College of Medicine. Participants will receive 2 injections of vaccine or placebo (substance made to look like the study vaccine but contains no medication) given 1 month apart. Participants will fill out a memory aid (diary) to document daily temperature and illness signs and symptoms for 7-9 days after each injection. During the 9 study visits, several blood samples will be collected. Participants will be in the study for up to 211 days, including screening.

NCT00533741 Coronavirus (SARS-CoV) Drug: Aluminum hydroxide Drug: Placebo Biological: SARS-CoV

MeSH:Coronavirus Infections

Primary Outcomes

Measure: Frequency and description of serious adverse events (SAEs).

Time: 5 months after receipt of the booster dose of vaccine.

Measure: Frequency of significant increases in serum antibody to CoV S protein in Enzyme Linked Immunosorbent Assay (ELISA) and in neutralization tests, and increases in Geometric Mean Titers (GMT)s in sera.

Time: Screening, 1 and 5 months after the booster dose of vaccine.

Measure: Frequency and severity of solicited injection site and systemic signs and symptoms and unsolicited adverse events (AE) / SAEs.

Time: 1 month after receipt of the first and second doses of vaccine.

Secondary Outcomes

Measure: Frequency of significant serum antibody increases and increases in Geometric Mean Titers (GMT)s, as measured in neutralizing antibody tests and an ELISA against SARS-CoV S protein.

Time: Collected just before the first vaccination and at 1 month (just before booster).

9 A Multi-centre, Double-blinded, Randomized, Placebo-controlled Trial on the Efficacy and Safety of Lopinavir / Ritonavir Plus Ribavirin in the Treatment of Severe Acute Respiratory Syndrome

The study aims to examine whether the combination of Lopinavir/Ritonavir plus Ribavirin for treatment of severe acute respiratory syndrome (SARS) is superior to placebo.

NCT00578825 Severe Acute Respiratory Syndrome Drug: Lopinavir / Ritonavir plus Ribavirin

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Syndrome

Primary Outcomes

Measure: Development of severe SARS

Time: Any time during the acute illness

Secondary Outcomes

Measure: Adverse events

Time: Throughout the illness period

Measure: SARS-CoV Viral load

Time: Throughout the illness period

Measure: Immunological profile

Time: Throughout the illness period

10 An International Observational Study to Characterize Adults Who Are Hospitalized With Influenza or Other Targeted Respiratory Viruses

Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to estimate rates of morbidity and mortality and to examine predictors of severity among participants with 2009 H1N1 infection. In 2011, as surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes and influenza B viruses. The current version of the protocol (released in August 2013) further broadens the scope of this observational study. With the recognition that novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health importance, the objectives of this protocol have been expanded.

NCT01056185 Influenza Novel Respiratory Virus-1 Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV) Novel Respiratory Virus-2 Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)

MeSH:Influenza, Human Coronavirus Infections Severe Acute Respiratory Syndrome Syndrome Virus Diseases

Primary Outcomes

Measure: Death

Time: 60-day period following enrollment

Secondary Outcomes

Measure: Recovery from influenza illness (including days lost from normal activities) duration of hospitalization, days in intensive care, days of mechanical ventilation, days of dialysis, pregnancy outcome

Time: approximately 60 days

11 Testing of Respiratory Specimens for the Validation of the QIAGEN ResPlex II Advanced Panel Test and the Artus Influenza A/B RT-PCR Test

The study will be conducted using nasopharyngeal swab specimens collected prospectively from individuals suspected of having the signs and symptoms of an acute respiratory tract infection caused by a respiratory virus. A series of standard viral culture tests validated for routine use in the clinical laboratory, and/or a series of PCR-based Laboratory Developed Tests (PCR-LDT) validated by a central reference laboratory will be used to verify the performance of the investigational artus Influenza A/B RT-PCR test and the QIAGEN ResPlex II Advanced Panel test. From each specimen five (5) aliquots will be prepared: (a) one aliquot will be tested in real-time using the assigned viral culture reference methods; (b) one aliquot will be used to extract nucleic acid in real-time for investigational testing; (c) one aliquot of the specimen will be stored at --70C for subsequent shipment to the reference laboratory for PCR-LDT testing, (d) one aliquot will be archived at -70C for subsequent follow-up by the reference laboratory (e.g., bi-directional sequencing of positive specimens), and (e) any remaining specimen will be stored for the Fresh vs. Frozen Study. The extracted nucleic acid generated from the second aliquot (i.e., "b" above) will be split and subjected to testing by both the artus Influenza A/B RT-PCR test and the ResPlex II Advanced Panel test.

NCT01302418 QIAGEN ResPlex II Advanced Panel Influenza A Respiratory Respiratory Syncytial Virus Infections Infection Due to Human Parainfluenza Virus 1 Parainfluenza Type 2 Parainfluenza Type 3 Parainfluenza Type 4 Human Metapneumovirus A/B Rhinovirus Coxsackie Virus/Echovirus Adenovirus Types B/C/E Coronavirus Subtypes 229E Coronavirus Subtype NL63 Coronavirus Subtype OC43 Coronavirus Subtype HKU1 Human Bocavirus Artus Influenza A/B RT-PCR Test Influenza B Device: artus Influenza A/B RT-PCR Test

MeSH:Infection Communicable Diseases Influenza, Human Coronavirus Infections Adenoviridae Infections Respiratory Syncytial Virus Infections Paramyxoviridae Infections Coxsackievirus Infections Virus Diseases

Primary Outcomes

Description: The presence of Influenza A or Influenza B virus.

Measure: Detection of Respiratory Viruses

Time: Specimens will be taken within 5 days of the appearance of symptoms.

12 Seroprevalence of IgG Antibodies to Middle East Respiratory Syndrome Coronavirus in Asymptomatic Healthcare Workers After Treatment of Confirmed MERS Patient

The investigators aim to do serosurvey of healthcare-personnel who had participated in treatment of confirmed patients of Middle-East respiratory syndrome. The investigators collected the base-line (pre-exposure) serum of healthcare-personnel in a few centers, and will collect the post-exposure serum from about 25-30 centers in which confirmed MERS patients had been treated. The investigators will deduct the seroprevalence of MERS-CoV IgG among the healthy healthcare-personnel, and calculate the sero-conversion rate if possible. The investigators will subdivided the seroprevalence according to the degree of exposure and preparedness of personal protective equipment.

NCT02497885 Coronavirus Infections

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: MERS-CoV IgG(+)

Measure: IgG(+)

Time: up to 4-5 month

13 A Phase 1, Randomized Double-Blind, Placebo-Controlled, Single Ascending Dose Safety, Tolerability, and Pharmacokinetics Study of SAB-301 in Healthy Adults

Background: Middle East Respiratory Syndrome (MERS) is a newly discovered contagious and sometimes fatal respiratory virus. People often get MERS through close contact with an infected person. Scientists are worried that MERS may spread and cause more infections. There are no vaccines or treatments for MERS right now. Researchers think a new therapy called SAB-301 may be able to help. Antibodies are proteins the body makes to attack viruses. SAB-301 is made of antibodies made in cows to fight MERS. The antibodies are collected from plasma, the liquid part of cow blood. Objective: To evaluate the safety and tolerability of SAB-301 in healthy adults. Eligibility: Healthy people ages 18 60 who: Do not have chronic medical problems Do not take any medications (exceptions are acetaminophen, ibuprofen, vitamins, seasonal allergy meds and oral contraception) Do not have allergies to beef products Agree to use two forms of contraception while on study (both men and women) Design: Participants will be screened with: Medical history Physical examination Blood and urine tests Participants will have a return visit. They will have a physical exam and blood tests. They will be randomly assigned to receive either SAB-301 or a placebo which is given by infusion through an arm vein over 1 3 hours. They will be monitored at the clinic for 6 hours after the infusion. They will have additional blood draws. Participants will have 2-hour visits 1, 3, 7, 21, 42, and 90 days after the infusion. At each visit they will be evaluated and have blood and urine tests.

NCT02788188 Middle East Respiratory Syndrome Coronavirus Biological: SAB-301 Other: Normal (9%) Saline

MeSH:Coronavirus Infections

Primary Outcomes

Description: Number of participants who experienced an adverse event

Measure: Number of Participants Having Adverse Events

Time: 90 days

14 MERS-CoV Infection tReated With A Combination of Lopinavir /Ritonavir and Interferon Beta-1b: a Multicenter, Placebo-controlled, Double-blind Randomized Trial

This is a placebo-controlled clinical trial to assess the efficacy and safety of a combination of lopinavir/ritonavir and Interferon beta-1b in hospitalized patients with MERS.

NCT02845843 Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Drug: Combination of Lopinavir /Ritonavir and Interferon beta-1b Drug: Placebo

MeSH:Coronavirus Infections

Primary Outcomes

Measure: 90-day mortality

Time: 90-day

Secondary Outcomes

Measure: Organ support-free days (e.g., supplemental O2, ventilator, extracorporeal membrane oxygenation (ECMO), renal replacement and vasopressors)

Time: 28 days

Measure: RT-PCR cycle threshold value in the lower respiratory samples

Time: At randomization and every 3 days afterwards, until 2 consecutive samples are negative or reaching a maximum of 90 days

Measure: Sequential organ failure assessment (SOFA) scores

Time: Days 0, 3, 7, 14, 21 and 28

Measure: ICU-free days

Time: Number of days in which patients are not being cared for in the ICU during the first 28 days after enrollment

Measure: Length of stay in hospital

Time: Up to one year from enrollment

Measure: Number of Patients with Adverse drug reactions related to the treatment

Time: From enrollment to 28 day

Measure: Karnofsky Performance Scale

Time: 90-day

Measure: ICU mortality

Time: Up to one year from enrollment

Measure: Hospital mortality

Time: Up to one year from enrollment

Measure: 28-day mortality

Time: 28-day

15 Implementation of Lung Protective Ventilation in Patients With Acute Respiratory Failure

This is a quality improvement study with the purpose of observing and measuring the effects of implementation of a proven standardized lung protective ventilation protocol in the new electronic medical record system iCentra across all Intermountain Healthcare hospitals. Approximately 14,000 records will be accessed for this study from a database of mechanically ventilated patients established for quality improvement purposes. The investigators hypothesize that implementation of a standardized computerized lung protective ventilation protocol across all Intermountain Healthcare hospitals will be feasible, will decrease initial tidal volumes to the target 6 ml/kg PBW, and will improve outcomes. The objectives of this study are to: - Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal volume ventilation protocol on initiation of mechanical ventilation) improves outcomes in patients with acute respiratory failure requiring mechanical ventilation - Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal volume ventilation protocol on initiation of mechanical ventilation) improves outcomes in the sub-group of patients with the acute respiratory distress syndrome (ARDS) - Measure compliance with the implementation of a computerized lung protective ventilation protocol at 12 Intermountain Healthcare hospitals

NCT03225807 Acute Respiratory Distress Syndrome ARDS Respiratory Distress Syndrome, Acute Respiratory Insufficiency Respiratory Distress Syndrome Shock Lung Severe Acute Respiratory Syndrome

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Pulmonary Valve Insufficiency Syndrome

HPO:Pulmonary insufficiency

Primary Outcomes

Measure: Ventilator free days to day 28

Time: 28 days

Secondary Outcomes

Measure: 30 day mortality

Time: 30 days

Measure: 90 day mortality

Time: 90 days

Measure: Hospital discharge disposition

Time: 30 days

Measure: Hospital mortality

Time: 1 week

Measure: Time to first ICU activity

Time: 24 hours

16 A Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Co-administered MERS-CoV Antibodies REGN3048 and REGN3051 vs. Placebo in Healthy Adults

This is a Phase 1, first-in-human (FIH), single site, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single ascending doses of a co-administered (1:1, w/w) combination of REGN3048 and REGN3051 mAb's, administered IV in healthy adult volunteers. Study duration of approximately 16 months. Approximately 48 evaluable subjects will be enrolled in the study, eight (8) subjects in each one of 6 sequential ascending IV dose cohorts. In each cohort, subjects will be randomized to receive mAb's REGN3048 and REGN3051 (6 subjects) or placebo (2 subjects). Primary Objective: To assess the safety and tolerability of REGN3048 and REGN3051 following co-administration of single, ascending IV doses of 1.5, 5, 15, 25, 50, and 75 mg/kg of each of the two mAb's.

NCT03301090 Corona Virus Infection Other: Placebo Biological: REGN3048 Biological: REGN3051

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Changes from baseline in abbreviated physical examination

Time: Days 1-2

Measure: Changes from baseline in clinical safety laboratory values

Time: From Day 2 up to Day 121

Measure: Changes from baseline in Electrocardiogram (ECG) parameters

Time: 15 mins after infusion

Measure: Changes from baseline in Electrocardiogram (ECG) parameters

Time: 24 hrs after infusion

Measure: Changes from baseline in symptom-directed physical examination

Time: From Day 1 up to Day 121

Measure: Changes from baseline in vital signs

Time: From Day 1 up to Day 121

Measure: The incidence of Adverse Events

Time: From Day 1 up to Day 121

Measure: The incidence of treatment-emergent Serious Adverse Events

Time: From Day 1 up to Day 121

Measure: The severity of Adverse Events assessed by toxicity grading criteria

Time: From Day 1 up to Day 121

Measure: The severity of treatment-emergent Serious Adverse Events assessed by toxicity grading criteria

Time: From Day 1 up to Day 121

Measure: The type of treatment-emergent Serious Adverse Events

Time: From Day 1 up to Day 121

Secondary Outcomes

Measure: AUC for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

Time: From Day 1 up to Day 121

Measure: AUC for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

Time: From Day 1 up to Day 121

Measure: AUC(0-infinity) for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

Time: From Day 1 up to Day 121

Measure: AUC(0-infinity) for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

Time: From Day 1 up to Day 121

Measure: CL for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

Time: From Day 1 up to Day 121

Measure: CL for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

Time: From Day 1 up to Day 121

Measure: CMAX for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

Time: From Day 1 up to Day 121

Measure: CMAX for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

Time: From Day 1 up to Day 121

Measure: K(e) for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

Time: From Day 1 up to Day 121

Measure: K(e) for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

Time: From Day 1 up to Day 121

Measure: t(1/2) for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

Time: From Day 1 up to Day 121

Measure: t(1/2) for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

Time: From Day 1 up to Day 121

Measure: The change from baseline of antibodies against REGN3048 and REGN3051 (anti-drug antibodies, ADA), as measured in serum using validated bridging assays

Time: Day 121

Measure: The change from baseline of antibodies against REGN3048 and REGN3051 (anti-drug antibodies, ADA), as measured in serum using validated bridging assays

Time: Day 57

Measure: TMAX for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

Time: From Day 1 up to Day 121

Measure: TMAX for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

Time: From Day 1 up to Day 121

Measure: V(ss) for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

Time: From Day 1 up to Day 121

Measure: V(ss) for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

Time: From Day 1 up to Day 121

17 An Open Label Safety Study of Inhaled Gaseous Nitric Oxide (gNO) for Adults & Adolescents With Non-Tuberculous Mycobacteria, Burkholderia Spp, Aspergillus Spp and Corona-like Viral (Sub-Study) Infections

Non tuberculous mycobacteria (NTM), Burkholdria spp, Aspergillus in the lung are almost impossible to eradicate with conventional antibiotics. In addition COVID-19 has know current treatment. These patients have few options to treat their lung infection. Nitric oxide has broad bactericidal and virucidal properties. It has been shown that nitric oxide was safe to be inhaled for similar cystic fibrosis patients and reduced drug resistant bacteria in the lungs. Further, research indicates that clinical isolates of NTM, Burkholderia spp, Aspergillus spp and Corona-like viruses can be eradicated by 160ppm NO exposure in the laboratory petri dish. This is not the first time inhaled NO treatment has been used in patients with difficult lung infections. This study will provide more data to see if NO therapy can reduce the bacterial load in the lungs, help the patients breath better; and in the case of COVID-19 act as a anti-viral agent resulting in the reduction of incidence of oxygen therapy, mechanical assistance of BIPAP, CPAP, intubation and mechanical ventilation during the study period.

NCT03331445 Respiratory Tract Infections Corona Virus Infection Drug: Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation

MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome

HPO:Respiratory tract infection

Primary Outcomes

Description: Measure the number of unanticipated adverse events over the duration of the study protocol

Measure: Measure the safety of 160ppm inhaled nitric oxide delivery in NTM subjects

Time: 26 Days

Secondary Outcomes

Description: Measure the change in absolute FEV1.0 change from baseline during 160 ppm inhalation therapy

Measure: Measure the effect of 160ppm inhaled nitric oxide delivery on lung spirometry in NTM subjects

Time: Day 5,12,19 and 26

Description: Measure the difference from baseline NTM species bacterial load (0 to +4) in sputum during 160ppm nitric oxide inhalation therapy

Measure: Measure the antimicrobial effect of 160ppm inhaled nitric oxide on lung NTM bacterial load in the sputum

Time: Day 19 and 26

Description: Measure the difference from baseline CRISS (0-100) during 160ppm nitric oxide inhalation therapy (lower score represents higher quality of life)

Measure: Measure the effect of 160ppm inhaled nitric oxide on Quality of Life (CRISS) Score

Time: Day 19 and 26

Other Outcomes

Description: Measuring reduction in the incidence of mechanical assistance including oxygen therapy, BIPAP, CPAP, intubation and mechanical ventilation during the study period.

Measure: Sub-Study Primary Endpoint(s): Efficacy to reduce respiratory interventions

Time: Day 26

Description: Measured by death from all causes

Measure: Efficacy in reduction of mortality

Time: Day 26

Description: Assessed by time to negative conversion of COVID-19 RT-PCR from upper respiratory tract

Measure: Antiviral effect

Time: Day 26

Description: Time to clinical recovery as measured by resolution of clinical signs

Measure: Efficacy on clinical improvement

Time: Day 26

Description: Measured by change in the Modified Jackson Cold Score

Measure: Efficacy on the respiratory symptoms

Time: Day 26

18 A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Vaccine ChAdOx1 MERS in UK Healthy Adult Volunteers

This is a clinical trial in which healthy volunteers will be administered an experimental MERS vaccine. The vaccine ChAdOx1 MERS will be administered alone both as a single administration and with a homologous prime-booster.

NCT03399578 MERS (Middle East Respiratory Syndrome) Biological: ChAdOx1 MERS

MeSH:Coronavirus Infections Syndrome

Primary Outcomes

Description: The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events. Change from baseline for safety laboratory measures will also be collected. Occurrence of serious adverse events will be collected during the whole study duration

Measure: Occurrence of solicited and unsolicited local and systemic adverse events

Time: up to 28 days following vaccination

Secondary Outcomes

Description: ELISA to quantify antibodies to MERS Spike protein antigen Ex vivo ELISpot responses to MERS Spike protein antigen

Measure: Measures of immunogenicity to the ChAdOx1 MERS vaccine

Time: 12 months

19 The 15-year Impact of Severe Acute Respiratory Syndrome on Organ Functions, Exercise Capacity, and Quality of Life in Survivors.

SARS-CoV has caused severe epidemic respiratory disease in human populations. By July 2003, a total of 8,096 probable cases of SARS had been reported including 774 deaths in 27 countries, around one-third of which were health care workers (HCWs). Previous studies have been reported about long-term impacts of SARS infection, including lung function deficiency, steroid-induced osteonecrosis, reduced exercise capacity, and impairment in health-related quality of life (HRQoL). HCWs, especially nurses, have been reported to experience greater psychological distress, particularly increased levels of posttraumatic stress symptomatology (PTSS). But the very complex impacts of this fatal infection on HCWs have not been fully elucidated. It is thus important to follow these occupational patients to detect and manage multi-organ sequelae and functional impairment.

NCT03443102 SARS Virus Long-Term Survivors

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: Disabilities arising from physical injuries and/or mental stresses

Measure: All-cause disability

Time: Evaluations would be finished within 90 days after enrollment.

Secondary Outcomes

Description: The interrelationship between the workings of the heart and lung organs would be assessed by assessed by 6MWT (6-min walk test)

Measure: Cardiopulmonary function

Time: Evaluations would be finished within 90 days after enrollment.

Description: Quality of life would be assessed by the Medical Outcomes Study 36-item short form version 2 (SF-36)

Measure: Life Life quaities mental distress

Time: Evaluations would be finished within 90 days after enrollment.

20 Streptokinase Versus Unfractionated Heparin Nebulization in Patients With Severe Acute Respiratory Distress Syndrome (ARDS): A Partially Randomized Controlled Trial

Background: Intra-alveolar clotting and alveolar collapse in ARDS is due to alveolar capillaries epithelial and leakage. Subsequently, collapse induces hypoxemia that is resistant to recruitment (RM). Heparin and Streptokinase may prevent or dissolve intra-alveolar fibrin clot respectively helping alveolar re-expansion. We examined and compared the effect of nebulizing Heparin versus Streptokinase on reversing this pathology. Methods: Sixty severe ARDS (PaO2/FiO2<100) patients and failure of RM, prone position (PP) and neuromuscular block (NMB) were partially randomised into Group (I): (n=20) received nebulized Heparin 10000 IU/4h. Group (II): (n=20) received nebulized Streptokinase 250,000 IU/4h. Group (III): (n=20) received conservative management. Randomization to either Heparin or Streptokinase groups was applied to patients whom guardian accepted participation, while those who declined participation were followed-up as a control. The primary outcome was the change in PaO2/FiO2; the secondary outcomes included the change in compliance, plateau pressure, ventilation-off days, coagulation and ICU mortality.

NCT03465085 Acute Respiratory Distress Syndrome Severe Acute Respiratory Syndrome Drug: Unfractionated heparin Drug: Streptokinase

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Respiratory Distress Syndro Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Description: Change in the ratio of arterial oxygen tension to fraction of inspired oxygen from the baseline (day 0, before randomization and or the start of intervention) to day 1 to day 8 after the randomization and or start of intervention.

Measure: Change in PaO2/FiO2 ratio

Time: daily over eight days

Secondary Outcomes

Description: Change in the plateau airway pressure during ventilation from the baseline (day 0, before randomization and or the start of intervention) to day 1 to day 8 after the randomization and or start of intervention.

Measure: Change in the plateau pressure

Time: daily over eight days

Description: change in volume of the lungs per change in pressure during ventilation from the baseline (day 0, before randomization and or the start of intervention) to day 1 to day 8 after the randomization and or start of intervention.

Measure: Change in the pulmonary compliance

Time: daily over eight days

Description: Number of patients who are discharged alive

Measure: ICU survival rate

Time: At the end of ICU stay up to one year after the start of recruitment

Description: the total duration the patient stays in ICU

Measure: ICU length of stay

Time: At the end of ICU stay up to one year after the start of recruitment

Description: number of patients who required tracheostomy

Measure: Tracheostomy rate

Time: During ICU stay up to one month after the start of recruitment

21 An Open, Single Center Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of Two Ascending Doses of the Candidate Vaccine MVA-MERS-S

The Middle East Respiratory Syndrome Coronavirus (MERS-CoV) is a potentially fatal disease with a reported lethality of up to 40% that is under tight epidemiologic control by the World Health Organization (WHO) and currently without registered prevention or treatment option. In this phase I first-in-human clinical trial, healthy volunteers in two different dose cohorts will be vaccinated twice with the candidate vaccine MVA-MERS-S. A subgroup will additionally receive a late booster vaccination. The aim of the study is to assess the safety and tolerability of the candidate vaccine and to characterize its immunogenicity.

NCT03615911 MERS (Middle East Respiratory Syndrome) Biological: vaccine candidate MVA-MERS-S

MeSH:Coronavirus Infections

Primary Outcomes

Description: The solicited local adverse events for this study include: Swelling, erythema, induration, hematoma and pain at site of injection The solicited systemic adverse events for this study include: Fever Chills Myalgia (described to the subject as generalized muscle aches) Arthralgia (described to the subject as generalized joint aches) Fatigue/Malaise Headache Gastrointestinal symptoms The reactogenicity (adverse events) will be assessed via a trained physician taking into account a patient diary. The severity of the adverse event will be measured as specified in the study protocol (grade 0=none, grade 1=mild, grade 2=moderate, grade 3=severe). The adverse event will furthermore be categorized in related vs. not related.

Measure: Occurrence of solicited local and systemic reactogenicity as defined by the study protocol

Time: 14 days after each vaccination

Description: The unsolicited adverse events will be assessed via a trained physician taking into account a patient diary. The severity of the adverse event will be measured as specified in the study protocol (grade 0=none, grade 1=mild, grade 2=moderate, grade 3=severe). The adverse event will furthermore be categorized in related vs. not related.

Measure: Occurrence of unsolicited adverse events

Time: 28 days after each vaccination

Description: The safety laboratory measures include: Troponin T Clinical Chemistry Hematology Urine

Measure: Change from baseline of safety laboratory measures as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4

Time: Throughout the study up to conclusion

Description: Serious adverse events are defined as any untoward medical occurrence (whether considered to be related to investigational medicinal product or not) that at any dose: results in death is life-threatening requires inpatient hospitalization or prolongation of existing hospitalization results in persistent or significant disability/incapacity is a congenital abnormality/birth defect is an Important Medical Event, i.e., an event that may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

Measure: Occurrence of serious adverse events

Time: Throughout the study up to conclusion

Secondary Outcomes

Description: Humoral immunity: The magnitude of MVA-MERS-S antibody responses as assessed by neutralization assay and ELISA

Measure: Measures of immunogenicity to the MVA-MERS-S vaccine

Time: Throughout the study up to conclusion

22 An Open Label, Dose-Escalation, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TAK-981 in Adult Patients With Advanced or Metastatic Solid Tumors or Relapsed/Refractory Hematologic Malignancies and in a Subset With Coronavirus Disease 2019

The primary objective of this study is to evaluate the safety and tolerability of TAK-981 as a single agent in participants with advanced or metastatic solid tumors and lymphomas in dose escalation and cancer treatment expansions, and to assess change in acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load within 8 days of TAK-981 administration in COVID expansion.

NCT03648372 Neoplasms Lymphoma Hematologic Neoplasms Coronavirus Disease Drug: TAK-981 Drug: Standard of care

MeSH:Coronavirus Infections Hematologic Neoplasms Neoplasms

HPO:Hematological neoplasm Leukemia Neoplasm

Primary Outcomes

Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants Reporting one or More Treatment Emergent Adverse Events (TEAEs)

Time: Up to 36 months

Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With Dose Limiting Toxicities (DLTs)

Time: Up to 36 months

Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With one or More Serious Adverse Events (SAEs)

Time: Up to 36 months

Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations

Time: Up to 36 months

Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With Greater Than or Equal to (>=) Grade 3 TEAEs

Time: Up to 36 months

Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With Clinically Significant Laboratory Values

Time: Up to 36 months

Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With Clinically Significant Vital Sign Measurements

Time: Up to 36 months

Description: CRS will be graded as per American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading for CRS.

Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants who Experience Cytokine Release Syndrome CRS)

Time: Up to 36 months

Measure: COVID-19 Expansion: Number of Participants With >=2 log Reduction From Baseline in Viral Load or Below Level of Detection (Negative) in Nasopharyngeal or Oropharyngeal Samples

Time: Up to 9 months

Secondary Outcomes

Measure: Dose Escalation and Cancer Treatment Expansions, Cmax: Maximum Observed Plasma Concentration for TAK-981

Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length is equal to [=] 21 days)

Measure: Dose Escalation and Cancer Treatment Expansions, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-981

Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)

Measure: Dose Escalation and Cancer Treatment Expansions, AUCt: Area Under the Plasma Concentration-time Curve from Time 0 to Time t Over the Dosing Interval for TAK-981

Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)

Measure: Dose Escalation and Cancer Treatment Expansions, AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-981

Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)

Measure: Dose Escalation and Cancer Treatment Expansions, Terminal Disposition Phase Half-life (t1/2z) for TAK-981

Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)

Measure: Dose Escalation and Cancer Treatment Expansions, Total Clearance After Intravenous Administration (CL) for TAK-981

Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)

Measure: Dose Escalation and Cancer Treatment Expansions, Volume of Distribution at Steady State After Intravenous Administration (Vss) for TAK-981

Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)

Description: ORR is defined as percentage of participants who achieve complete response (CR) and partial response (PR) through the study (approximately 3 years), as determined by the investigator according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1) for participants with solid tumors and Response Evaluation Criteria in Lymphoma (RECIL) for participants with lymphoma.

Measure: Dose Escalation and Cancer Treatment Expansions: Overall Response Rate (ORR)

Time: From the first dose until best response is achieved (up to approximately 3 years)

Description: DOR will be determined by the investigator according to RECIST V1.1 for participants with solid tumors and RECIL for participants with lymphoma.

Measure: Dose Escalation and Cancer Treatment Expansions: Duration of Response (DOR)

Time: From the time of documentation of tumor response to the first recorded occurrence of disease progression (PD) or death from any cause (whichever occurs first), through end of study (up to approximately 3 years)

Description: DCR is defined as percentage of participants who achieve stable disease (SD) or better greater than (>) 6 weeks during the study in response-evaluable population, as determined by the investigator according to RECIST V1.1 for participants with solid tumors and RECIL for participants with lymphoma.

Measure: Dose Escalation and Cancer Treatment Expansions: Disease Control Rate (DCR)

Time: From the first dose until best response is achieved (up to approximately 3 years)

Description: PFS will be determined by the investigator according to RECIST V1.1 for participants with solid tumors and RECIL for participants with lymphoma.

Measure: Dose Escalation and Cancer Treatment Expansions: Progression-free Survival (PFS)

Time: From the date of the first dose administration to the date of first documentation of PD or death due to any cause whichever occurs first, through the end of the study (up to approximately 3 years)

Description: TTR will be determined by the investigator according to RECIST V1.1 for participants with solid tumors and RECIL for participants with lymphoma.

Measure: Dose Escalation and Cancer Treatment Expansions: Time to Response (TTR)

Time: From the date of first study drug administration to the date of first documented PR or better (up to approximately 3 years)

Measure: Dose Escalation and Cancer Treatment Expansions: Percentage of Participants at Each Dose Level Demonstrating Adduct Formation in Post-dose Skin or Tumor Biopsies

Time: Up to Cycle 1 (approximately 3 weeks) (Cycle length =21 days)

Measure: Dose Escalation and Cancer Treatment Expansions: Percent Change in Small Ubiquitin-like Modifier (SUMO) 2/3 Signal With Pre and Post-dose Skin or Tumor Biopsies at Each Dose Level

Time: Up to Cycle 1 (approximately 3 weeks) (Cycle length =21 days)

Measure: COVID-19 Expansion: Number of Participants Reporting one or More TEAEs

Time: Up to 9 months

Description: Severity Grades will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE), version 5.0.

Measure: COVID-19 Expansion: Number of Participants Based on Severity of TEAEs

Time: Up to 9 months

Measure: COVID-19 Expansion: Number of Participants Based on Duration of TEAEs

Time: Up to 9 months

Description: CRS will be graded as per ASTCT Consensus Grading for CRS.

Measure: COVID-19 Expansion: Number of Participants who Experience CRS

Time: Up to 9 months

Description: NEWS determines the degree of illness of participants and prompts critical care intervention. It will be based on the score allocated to respiratory rate, peripheral capillary oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate and level of consciousness.

Measure: COVID-19 Expansion: Change from Baseline in National Early Warning Score (NEWS)

Time: Up to 9 months

Description: Percentage of participants will be reported based on severity rating on a 6-point ordinal scale, which will include: 1 (death); 2 (hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation, hospitalized); 3 (on non-invasive ventilation or high flow oxygen devices); 4 (hospitalized, requiring supplemental oxygen); 5 (hospitalized, not requiring supplemental oxygen); and 6 (not hospitalized).

Measure: COVID-19 Expansion: Percentage of Participants Reporting Each Hospitalization Severity Rating

Time: Up to 9 months

Description: Change from Baseline in SARS-CoV-2 viral Load in nasopharyngeal or oropharyngeal samples will be determined by viral response. The nasopharyngeal swab will be collected from both nostrils or from the same nostril every time.

Measure: COVID-19 Expansion: Change From Baseline in SARS-CoV-2 Viral Load in Nasopharyngeal or Oropharyngeal Samples

Time: Up to 9 months

Measure: COVID-19 Expansion: Percentage of Participants Requiring Oxygen Supplementation; Assisted or Positive Pressure Non-invasive Ventilation; and Invasive Ventilation, on Days 3, 5, 8, 11, 15, and 30

Time: Days 3, 5, 8, 11, 15, and 30

Measure: COVID-19 Expansion: Percentage of Participants That met Intensive Care Unit (ICU) Criteria

Time: Up to 9 months

Measure: COVID-19 Expansion: Duration of Hospitalization

Time: Up to 9 months

Description: Time from the first dose of TAK-981 to viral load negativity (below level of detection).

Measure: COVID-19 Expansion: Time to Viral Ribonucleic Acid (RNA) Negativity in Nasopharyngeal or Oropharyngeal Samples

Time: Up to 9 months

Description: Time from first dose of TAK-981 to participant's discharge or to NEWS score <=3. NEWS determines the degree of illness of participants and prompts critical care intervention. It will be based on the score allocated to respiratory rate, peripheral capillary oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate and level of consciousness.

Measure: COVID-19 Expansion: Time to Discharge or to a NEWS of Less Than or Equal to (<=) 3 and Maintained for 24 Hours

Time: Up to 9 months

Measure: COVID-19 Expansion: Number of Deaths in Hospital due to any Cause in First 30 Days and in 90 Days

Time: Days 30 and 90

23 Lessening Organ Dysfunction With VITamin C (LOVIT)

LOVIT is a multicentre concealed-allocation parallel-group blinded randomized controlled trial to ascertain the effect of high-dose intravenous vitamin C compared to placebo on mortality or persistent organ dysfunction at 28 days in septic intensive care unit patients. Patients with COVID-19 are considered eligible for this study.

NCT03680274 Sepsis Vitamin C Intensive Care Unit COVID-19 Pandemic Coronavirus Drug: Vitamin C Other: Control

MeSH:Coronavirus Infections

Primary Outcomes

Description: Defined as death or dependency on mechanical ventilation, renal replacement, or vasopressors

Measure: Number of deceased participants or with persistent organ dysfunction

Time: Both assessed at 28 days

Secondary Outcomes

Description: Persistent organ dysfunction-free days in intensive care unit

Measure: Number of participants with persistent organ dysfunction-free days in intensive care unit

Time: Up to day 28

Description: Mortality at 6 months

Measure: Number of participants deceased at 6 months

Time: 6 months

Description: Assessed by the questionnaire EuroQol-5D (EQ-5D-5L). The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.

Measure: Score of health related quality of life in 6-month survivors

Time: 6 months

Description: Assessed by serum lactate concentration

Measure: Global tissue dysoxia

Time: Days 1, 3, 7

Description: Assessed by the Sequential Organ Failure Assessment (SOFA) score. Used to track a person's status during the stay in an intensive care unit to determine the extent of a person's organ function or rate of failure. The score is based on 6 different sub-scores, one each for the respiratory (PaO2/FiO2 mmHg), cardiovascular (mean arterial pressure OR administration of vasopressors required), hepatic (liver bilirubin (mg/dl) [μmol/L]), coagulation (platelets×103/µl), renal (kidneys creatinine (mg/dl) [μmol/L] (or urine output)) and neurological (Glasgow coma scale). The sub-score of eah system ranges from 0 (best) to +4 (worst).

Measure: Organ function (including renal function)

Time: Days 1, 2, 3, 4, 7, 10, 14, 28

Description: Assessed by interleukin-1 beta (IL-1ß), tumor necrosis factor-alpha (TNF-α), C-reactive protein (CRP)

Measure: Rate of inflammation

Time: Days 1, 3, 7

Description: Assessed by procalcitonin (PCT)

Measure: Rate of infection

Time: Days 1, 3, 7

Description: Assessed by thrombomodulin (TM) and angiopoietin-2 (ANG-2)

Measure: Rate of endothelial injury

Time: Days 1, 3, 7

Description: Assessed by KDIGO (Kidney Disease: Improving Global Outcomes) criteria

Measure: Occurrence of stage 3 acute kidney injury

Time: Up to day 28

Description: clinician judgment of hemolysis, as recorded in the chart, OR hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following: reticulocyte count >2 times upper limit of normal at clinical site lab; haptoglobin < lower limit of normal at clinical site lab; indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab; Lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab. Severe hemolysis: - hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells

Measure: Acute hemolysis

Time: Up to day 28

Description: Core lab-validated glucose level of less than 3.8 mmol/L

Measure: Hypoglycemia

Time: During the time participants receive the 16 doses of the investigational product and the 7 days following the last dose

Description: Assessed by chromatography-tandem mass spectrometry

Measure: Vitamin C volume of distribution

Time: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy)

Description: Assessed by chromatography-tandem mass spectrometry

Measure: Vitamin C clearance

Time: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy)

Description: Assessed by chromatography-tandem mass spectrometry

Measure: Vitamin C plasma concentration

Time: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy)

24 A Two-center, Randomized, Double-blind, Placebo-controlled, Phase Ib Study to Assess the Safety, Tolerability and Immunogenicity of Two Ascending Doses of the Candidate Vaccine MVA-MERS-S_DF-1 in Healthy Study Subjects

The study will be a two center, randomized, double blind, placebo controlled study of the MVA MERS S_DF-1 candidate delivered by i.m. injection. To evaluate the MERS-S-specific antibody responses and safety profile induced by the two dosage levels of MVA-MERS-S_DF-1 the data will be compared to a placebo control group.

NCT04119440 MERS (Middle East Respiratory Syndrome) Biological: MVA-MERS-S_DF1 - Low Dose Biological: MVA-MERS-S_DF1 - High Dose Other: Placebo

MeSH:Coronavirus Infections

Primary Outcomes

Description: Safety and reactogenicity will be assesssed by observation, questionaire and diary. Changes from baseline for safety laboratory measures will be monitored. Occurence of SAE will be collected throughout the entire study duration.

Measure: Frequency of adverse events associated with MVA-MERS-S_DF-1.

Time: day 1, 14, 29, 42, 56, 84, 168, 336, 364

Measure: Frequency and severity of local injection site reactogenicity signs and symptoms

Time: day 1, 14, 29, 42, 84, 336

Secondary Outcomes

Description: Magnitude of MERS-S-specific antibody re-sponses (ELISA and neutralization assays) monitored in a centralized approved laboratory

Measure: Immunogenicity

Time: day 0, 14, 28, 42, 56, 70, 84, 168, 336, 364 (dependent on vaccination scheme)

25 Double-blind, Placebo-controlled Study With an Open Dose Selection Period for Assessing the Safety and Immunogenicity of the Drug "BVRS-GamVac-Combi", a Combined Vector Vaccine for the Prevention of the Middle East Respiratory Syndrome, Lyophilisate for the Preparation of a Solution for Intramuscular Administration, With the Participation of Healthy Volunteers

The Middle East respiratory syndrome coronavirus (MERS-CoV) was identified in 2012 during the first Middle East respiratory syndrome (MERS) outbreak. MERS-CoV causes an acute lower-respiratory infection in humans, with a fatality rate of ~34.5%. The aim of the study is to assess the safety and immunogenicity of heterologous adenoviral-based vaccine against MERS - BVRS-GamVac-Combi.

NCT04128059 MERS (Middle East Respiratory Syndrome) MERS Drug: BVRS-GamVac-Combi Other: placebo

MeSH:Coronavirus Infections Syndrome

Primary Outcomes

Description: Determination of Number of Participants With Adverse Events

Measure: Number of Participants With Adverse Events

Time: through the whole study, an average of 180 days

Description: Determination of Number of Participants With Serious Adverse Events

Measure: Number of Participants With Serious Adverse Events

Time: through the whole study, an average of 180 days

Description: Determination of Number of Participants with Solicited Local and Systemic Adverse Events

Measure: Number of Participants with Solicited Local and Systemic Adverse Events

Time: through the whole study, an average of 180 days

Description: Determination of antibody levels against the MERS-CoV glycoprotein S measured by an ELISA vs. baseline values (phase 1, phase 2) and placebo (phase 2)

Measure: Antibody levels against the MERS-CoV glycoprotein S measured by an enzyme-linked immunosorbent assay (ELISA)

Time: Time Frame for group 1 phase 1: at days 0, 7, 14, 21, 28, 42, 56 and 90. Time Frame for group 2 phase 1 and phase 2: at days 0, 7, 14, 21, 28, 35, 42, 56 and 90

Secondary Outcomes

Description: determination of specific T-cell- mediated response vs. baseline values and placebo

Measure: Assessment of antigen-specific cell-mediated immune response

Time: at 0, 14 and 28 days from the start of vaccination compared to baseline values (phase 1, phase 2) and placebo (phase 2)

Description: Determination of the neutralizing antibody titer for a virus in virus neutralization reaction vs. baseline values and placebo

Measure: Neutralizing antibody levels

Time: at days 0, 14 and 28 from the start of vaccination compared to baseline values

26 Double-blind, Placebo-controlled Study With an Open Dose Selection Period for Assessing the Safety and Immunogenicity of the Drug "BVRS-GamVac", a Vector Vaccine for the Prevention of the Middle East Respiratory Syndrome, Lyophilisate for the Preparation of a Solution for Intramuscular Administration, With the Participation of Healthy Volunteers

The Middle East respiratory syndrome coronavirus (MERS-CoV) was identified in 2012 during the first Middle East respiratory syndrome (MERS) outbreak. MERS-CoV causes an acute lower-respiratory infection in humans, with a fatality rate of ~34.5%. The aim of the study is to assess the safety and immunogenicity of adenoviral-based vaccine against MERS - BVRS-GamVac.

NCT04130594 MERS (Middle East Respiratory Syndrome) MERS Biological: BVRS-GamVac Other: placebo

MeSH:Coronavirus Infections Syndrome

Primary Outcomes

Description: Determination of Number of Participants With Adverse Events

Measure: Number of Participants With Adverse Events

Time: through the whole study, an average of 180 days

Description: Determination of Number of Participants With Serious Adverse Events

Measure: Number of Participants With Serious Adverse Events

Time: through the whole study, an average of 180 days

Description: Determination of Number of Participants with Solicited Local and Systemic Adverse Events

Measure: Number of Participants with Solicited Local and Systemic Adverse Events

Time: through the whole study, an average of 180 days

Description: Determination of antibody levels against the MERS-CoV glycoprotein S measured by an ELISA vs. baseline values (phase 1, phase 2) and placebo (phase 2)

Measure: Antibody levels against the MERS-CoV glycoprotein S measured by an enzyme-linked immunosorbent assay (ELISA)

Time: at days 0, 7, 14, 21, 28, 42, 56 and 90

Secondary Outcomes

Description: determination of specific T-cell- mediated response vs. baseline values (phase 1, phase 2) and placebo (phase 2)

Measure: Assessment of antigen-specific cell-mediated immune response

Time: at 0 and 14 days from the start of vaccination compared to baseline values (day 0)

Description: Determination of the neutralizing antibody titer for a virus in virus neutralization reaction vs. baseline values

Measure: Neutralizing antibody levels

Time: at days 0, 14 and 28

27 A Phase Ib Study to Determine the Safety and Immunogenicity of the Candidate Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Vaccine ChAdOx1 MERS in Healthy Adult Middle Eastern Volunteers

A phase Ib study to determine the safety and immunogenicity of the candidate Middle East Respiratory Syndrome Coronavirus (MERS-CoV) vaccine ChAdOx1 MERS in healthy adult Middle Eastern volunteers

NCT04170829 Middle East Respiratory Syndrome Coronavirus Biological: ChAdOx1 MERS

MeSH:Coronavirus Infections Syndrome

Primary Outcomes

Measure: Occurrence of solicited and unsolicited local and systemic adverse events

Time: 28 days following the vaccination

Secondary Outcomes

Description: ELISA to quantify antibodies to MERS Spike protein antigen Ex vivo ELISpot responses to MERS Spike protein antigen

Measure: Measures of immunogenicity to the ChAdOx1 MERS vaccine

Time: 6.5 months following completion of the vaccination regimen

28 Development of a Simple, Fast and Portable Recombinase Aided Amplification (RAA) Assay for 2019-nCoV

In late December 2019, several local health facilities reported clusters of patients with pneumonia of unknown cause that were epidemiologically linked to a seafood and wet animal wholesale market in Wuhan, Hubei Province, China. It is now confirmed that the etiology of this outbreak is a novel coronavirus, namely, 2019-nCoV. Of critical importance is rapid and simple diagnostic method to be used in clinical settings to timely inform and refine strategies that can prevent, control, and stop the spread of 2019-nCoV. Recombinase aided amplification (RAA) assay is a novel isothermal nucleic acid amplification technique in recent years, which has a variety of the advantages including high specificity and sensitivity, rapid detection (30 min), low cost, low equipment requirements and simple operation. The has successfully detected a variety of pathogens using this technique. To develop a RAA assay for 2019-nCoV with the advantages of high speed, simple operation and low cost, and overcomes the shortcomings of the existing molecular detection methods. The investigators established a real time reverse-transcription RAA (RT-RAA) assay for detection of 2019-nCoV. This assay was performed at 42°C within 30min using a portable real-time fluorescence detector, Recombinant plasmids containing conserved ORF1ab genes was used to analyze the specificity and sensitivity. Clinical specimens from patients who were suspected of being infected with 2019-nCoV were used to evaluate the performance of the assay. In parallel, The investigators also used the commercial RT-qPCR assay kit for 2019-nCoV as a reference.

NCT04245631 New Coronavirus Diagnostic Test: Recombinase aided amplification (RAA) assay

MeSH:Coronavirus Infections

Primary Outcomes

Description: Detection sensitivity is greater than 95%

Measure: Detection sensitivity is greater than 95%

Time: at baseline

Description: Detection specificity is greater than 95%

Measure: Detection specificity is greater than 95%

Time: at baseline

Secondary Outcomes

Description: Consistent with existing universal reagent detection rates greater than 95%

Measure: Consistent with existing universal reagent detection rates greater than 95%

Time: at baseline

29 A Randomized, Open-label, Controlled Study of the Efficacy of Lopinavir Plus Ritonavir and Arbidol for Treating With Patients With Novel Coronavirus Infection

The study explores the efficacy of lopinavir plus ritonavir and arbidol in treating with novel coronavirus infection. As a result this study would provide evidence for the clinical usage of these drugs in the future .

NCT04252885 Coronavirus Infections Drug: Lopinavir and Ritonavir Tablets Drug: Arbidol

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Novel coronaviral nucleic acid is measured in nose / throat swab at each time point.

Measure: The rate of virus inhibition

Time: Day 0, 2, 4, 7, 10, 14 and 21

Secondary Outcomes

Description: Body temperature will be followed everyday during time frame.

Measure: The disease prorogation-temperature

Time: Day 0 till day 21

Description: Respiratory rate will be followed everyday during time frame.

Measure: The disease prorogation-respiratory function 1

Time: Day 0 till day 21

Description: Oxygen saturation of blood will be followed everyday during time frame.

Measure: The disease prorogation-respiratory function 2

Time: Day 0 till day 21

Description: Chest imaging will be taken at each time point.

Measure: The disease prorogation-respiratory function 3

Time: Day 0, 4, 7, 10, 14 and 21

Other Outcomes

Description: Blood pressure and heart rate will be followed everyday during time frame.

Measure: Patients health condition-routine test

Time: Day 0 till day 21

Description: Liver function will be assessed as AST, ALT and TBIL at each time point.

Measure: Patients health condition-liver function

Time: Day 0, 4, 7, 10, 14 and 21

Description: Kidney function will be assessed as eGFR and creatine clearance rate at each time point.

Measure: Patients health condition-kidney function

Time: Day 0, 4, 7, 10, 14 and 21

Description: Blood routine and myocardial enzyme will be measured at each time point.

Measure: Patients health condition-other blood routine test

Time: Day 0, 4, 7, 10, 14 and 21

Description: Flow cytometry classification and counting and cytokines will be measured at each time point.

Measure: Patients health condition-blood routine test

Time: Day 0, 4, 7, 10, 14 and 21

30 Viral Excretion in Contact Subjects at High/Moderate Risk of Coronavirus 2019-nCoV Infection

NCT04259892 Coronavirus Biological: 2019-nCoV PCR

MeSH:Coronavirus Infections

Primary Outcomes

Description: PCR at day 0, day 3, day 5, day 7 and day 12 following the last high/moderate risk contact

Measure: Time to SARS-CoV-2 nasopharyngeal excretion, from the day of the first high/moderate risk contact to 12 days after the last high/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case.

Time: 12 days (+/-2)

Secondary Outcomes

Description: Patient Reported Outcome assessed daily (fever > 38°C, asthenia/fatigue/malaise, headache, thrills/sweating, myalgia/aches, cough, dyspnea, Acute Respiratory Distress Syndrome, diarrhea, abdominal pain, ...)

Measure: Time to apparition of any symptom suggestive of SARS-CoV-2 from the day of the first high/moderate risk contact to 12 days after the last high/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case.

Time: 12 days (+/-2)

Description: nasopharyngeal excretion assessed by PCR at day 0, day 3, day 5, day 7 and day 12 following the last high/moderate risk contact

Measure: Factors associated with the time to SARS-CoV-2 nasopharyngeal excretion

Time: 12 days (+/-2)

Measure: Factors associated with the time to apparition of any symptom suggestive of SARS-CoV-2 infection

Time: 12 days (+/-2)

Measure: Proportion of contact subjects with apparition of any symptom suggestive of SARS-CoV-2 infection

Time: 12 days (+/-2)

Description: ELISA, microneutralisation essay

Measure: Proportion of contact subjects with positive serology defined as the presence of SARS-CoV-2 IgM or IgG at day 30 (+/-7) following last contact

Time: 30 days (+/-7)

Description: Whole exome sequencing

Measure: Host genetic variants

Time: 1 day

Description: ELISA, microneutralisation essay

Measure: The time (days) between the first positive SARS-CoV-2 serology and the first negative SARS-CoV-2 serology.

Time: 365 days (+/-30)

31 A Randomized, Open-label, Multi-centre Clinical Trial Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Confirmed Cases of Pneumonia Caused by Novel Coronavirus Infection

Base on Arbidol antiviral therapy,the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of ASC09 /ritonavir and lopinavir/ritonavir in patients with 2019-nCoV pneumonia.

NCT04261907 2019-nCoV Drug: ASC09/ritonavir group Drug: lopinavir/ritonavir group

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Defined as(one of them) SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤ 300mmHg or RR ≥ 30 breaths per.

Measure: The incidence of composite adverse outcome

Time: 14 days

Secondary Outcomes

Description: Clinical recovery was defined as( one of them): sustained (48 hours) alleviation of illness based on symptom scores (fever, cough,diarrhea, myalgia, dyspnea) all being absent and no evidence for progression (newly-presented dyspnea, SpO2 decline ≥3%, respiratory rate ≥ 24 breaths per min without supplemental oxygen). Or undectable viral RNA.

Measure: Time to recovery

Time: 14 days

Measure: Rate of no fever

Time: 14 days

Measure: Rate of no cough

Time: 14 days

Measure: Rate of no dyspnea

Time: 14 days

Measure: Rate of no requring supplemental oxygen

Time: 14 days

Measure: Rate of undectable viral RNA

Time: 14 days

Measure: Rate of mechanical ventilation

Time: 14 days

Measure: Rate of ICU admission

Time: 14 days

Measure: Time and rate of laboratory indicators related to disease improvement to return to normal

Time: 14 days

32 Clinical Characterisation Protocol for Severe Emerging Infections

Infectious disease is the single biggest cause of death worldwide. New infectious agents, such as the SARS, MERS and other novel coronavirus, novel influenza viruses, viruses causing viral haemorrhagic fever (e.g. Ebola), and viruses that affect the central nervous system (CNS) such as TBEV & Nipah require investigation to understand pathogen biology and pathogenesis in the host. Even for known infections, resistance to antimicrobial therapies is widespread, and treatments to control potentially deleterious host responses are lacking. In order to develop a mechanistic understanding of disease processes, such that risk factors for severe illness can be identified and treatments can be developed, it is necessary to understand pathogen characteristics associated with virulence, the replication dynamics and in-host evolution of the pathogen, the dynamics of the host response, the pharmacology of antimicrobial or host-directed therapies, the transmission dynamics, and factors underlying individual susceptibility. The work proposed here may require sampling that will not immediately benefit the participants. It may also require analysis of the host genome, which may reveal other information about disease susceptibility or other aspects of health status.

NCT04262921 Coronavirus Infections

MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Describe the clinical features of the illness or syndrome (cardio-respiratory signs or symptoms, and laboratory results) and complications, and determinants of severity. Assessment daily for 15 days, then weekly until max 100 days, then 3 and 6 months.

Measure: Clinical features

Time: 6 months

Description: Describe the response to treatments (including supportive care and novel therapeutics) by clinical, biological, radiological and virological assessments. Assessment daily for 15 days, then weekly until max 100 days, then 3 and 6 months.

Measure: Response to treatment

Time: 6 months

Description: high-throughput sequencing of pathogen genomes obtained from respiratory tract, blood, urine, stool, CSF and other samples. Assessment on Day 1, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15 then weekly until max 100 days, then 3 and 6 months.

Measure: Pathogen replication, excretion and evolution, within the host

Time: 6 months

Description: Characterise the innate and acquired immune responses, circulating levels of immune signalling molecules and gene expression profiling in peripheral blood. Assessment on Day 1, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15 then weekly until max 100 days, then 3 and 6 months.

Measure: Immune host responses to infection and therapy

Time: 6 months

Description: Identify host genetic variants associated with disease progression or severity

Measure: Host genetic variants

Time: Day 1

33 Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Severe COVID-19

The novel coronavirus pneumonia is a kind of new emerging respiratory infectious disease, characterized by fever, dry cough, and chest tightness, and caused by the infection of the 2019 novel coronavirus (2019-nCoV). In severe cases, there will be rapid respiratory system failure. The novel coronavirus pneumonia is extremely contagious and the disease progresses rapidly. It has become a urgent and serious public health event that threatens human life and health globally. Among them, severe pneumonia caused by novel coronavirus is characterized by extensive acute inflammation of the lungs and the patient is critically ill. At present, there is no effective treatment in clinical practice.Most of them should receive supportive care to help relieve symptoms. For severe cases, treatment should include care to support vital organ functions. This clinical trial is to inspect the safety and efficiency of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) therapy for severe pneumonia patients infected with 2019-nCoV.

NCT04273646 2019 Novel Coronavirus Pneumonia COVID-19 Biological: UC-MSCs Drug: Placebo

MeSH:Coronavirus Infections Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: Evaluation of Pneumonia Improvement

Measure: Pneumonia severity index

Time: From Baseline (0W) to 12 week after treatment

Description: Evaluation of Pneumonia Improvement

Measure: Oxygenation index (PaO2/FiO2)

Time: From Baseline (0W) to 12 week after treatment

Secondary Outcomes

Description: Incidence of acute and chronic treatment-related adverse events in patients with novel coronavirus severe pneumonia receiving UC-MSCs infusion as assessed.

Measure: Side effects in the UC-MSCs treatment group

Time: From Baseline (0W) to 96 week after treatment

Description: Marker for efficacy of treatment

Measure: 28-days survival

Time: Day 28

Description: Markers of organ function（Score each criterion on a scale of 0 to 4, and the higher the score, the worse the prognosis.）

Measure: Sequential organ failure assessment

Time: Day 28

Description: Markers of Infection

Measure: C-reactive protein

Time: From Baseline (0W) to 12 week after treatment

Description: Markers of Infection

Measure: Procalcitonin

Time: From Baseline (0W) to 12 week after treatment

Description: Marker of Immunological function

Measure: Lymphocyte count

Time: From Baseline (0W) to 12 week after treatment

Description: Marker of Immunological function

Measure: CD3+, CD4+ and CD8+ T celll count

Time: From Baseline (0W) to 12 week after treatment

Description: Marker of Immunological function

Measure: CD4+/CD8+ratio

Time: From Baseline (0W) to 12 week after treatment

34 Evaluating the Efficacy and Safety of Bromhexine Hydrochloride Tablets Combined With Standard Treatment/ Standard Treatment in Patients With Suspected and Mild Novel Coronavirus Pneumonia (COVID-19)

Compare the efficacy and safety of Bromhexine Hydrochloride Tablets combined with standard treatment/ standard treatment in patients with suspected and mild, or common novel coronavirus pneumonia (COVID-19). Random, open, group sequential design.

NCT04273763 Novel Coronavirus Pneumonia 2019-nCoV Drug: Bromhexine Hydrochloride Tablets Drug: Arbidol Hydrochloride Granules Drug: Recombinant Human Interferon α2b Spray

MeSH:Coronavirus Infections Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: Defined as random to fever, respiratory rate return to normal and cough remission over 48 hours.

Measure: Time to clinical recovery after treatment

Time: within 14 days from the start of medication

Description: Aggravation was defined as(one of them): respiratory distress, RR ≥ 30 times / min; SpO2 ≤ 93% in resting state; arterial partial pressure of oxygen (PaO2) /concentration of oxygen (FiO2) ≤ 300mmHg

Measure: Rate of aggravation

Time: within 14 days from the start of medication

Secondary Outcomes

Description: Clinical remission was defined as (one of them): sustained (more than 48 hours) alleviation of illness based on symptom (fever, cough, dyspnea, myalgia, diarrhea and so on) all being absent and no evidence for progression.

Measure: Clinical remission rate

Time: within 14 days from the start of medication

Description: oxygenation index

Measure: Dynamic changes of oxygenation index

Time: within 14 days from the start of medication

Description: time of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery

Measure: Time to cure

Time: within 14 days from the start of medication

Description: proportion of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery among infected patients

Measure: rate to cure

Time: within 14 days from the start of medication

Description: defervescence is defined as below 37 Celcius degrees（ear temperature）

Measure: Time to defervescence

Time: within 14 days from the start of medication

Measure: Time to cough remission

Time: within 14 days from the start of medication

Measure: Time to dyspnea remission

Time: within 14 days from the start of medication

Measure: Days of supplemental oxygenation

Time: within 14 days from the start of medication

Measure: Rate of patients with requring supplemental oxygen

Time: within 14 days from the start of medication

Measure: Rate of patients with mechanical ventilation

Time: within 14 days from the start of medication

Measure: Time of negative COVID-19 nucleic acid results

Time: within 14 days from the start of medication

Measure: Rate of negative COVID-19 nucleic acid results

Time: within 14 days from the start of medication

Measure: Rate of ICU admission

Time: within 14 days from the start of medication

Measure: 28-day mortality

Time: From the first day of screening to the day of follow-up (28 days)

35 Identifying Critically-ill Patients With COVID-19 Who Will Benefit Most From Nutrition Support Therapy: Validation of the NUTRIC Nutritional Risk Assessment Tool (COV_NUTRIC)

There was an interaction between mortality, nutritional intake and the Nutrition Risk in Critically ill (NUTRIC) score suggesting that those with higher NUTRIC scores benefited the most from increasing nutritional intake. Yet limited data were in Chinese patients. The current outbreak of novel coronavirus, named COVID-19, was first reported from Wuhan, China on Dec ember 31 , 2019. There are about 16% patients need ICU admission. The objective of this study is to validation of the "NUTRIC" nutritional risk assessment tool in Chinese ICU patients diagnosed as COVID-19.

NCT04274322 Critically Ill Coronavirus Infections Other: Nutrition support

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Critical Illness

Primary Outcomes

Measure: 28-day all cause mortality

Time: from admission to 28-day/discharge, an average of length of ICU stay is 28-day

Secondary Outcomes

Measure: All cause infection

Time: from admission to 28-day/discharge, an average of length of ICU stay is 28-day

Measure: The rate of complications

Time: from admission to 28-day/discharge, an average of length of ICU stay is 28-day

Measure: Length of ICU stay

Time: from admission to 28-day/discharge, an average of length of ICU stay is 28-day

Measure: Duration of mechanical ventilation

Time: from admission to 28-day/discharge, an average of length of ICU stay is 28-day

36 Retrospective Cohort to Evaluate the Effectiveness and Safety of Xiyanping Injection Combined With Conventional Treatment for New Coronavirus Infection Pneumonia (Common Type)

the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of Xiyanping injection in patients with 2019-nCoV pneumonia.

NCT04275388 2019 Novel Coronavirus Pneumonia Drug: Xiyanping injection Drug: Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride

MeSH:Coronavirus Infections Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: From the beginning of study drug use to fever, respiratory rate, blood oxygen saturation to normal and cough relief, and maintained for at least 72 hours or more, calculated in hours

Measure: Clinical recovery time

Time: Up to Day 14

Secondary Outcomes

Description: From the beginning of research drug use to body temperature <37.3 ℃ (underarm) or mouth temperature ≤37.5 ° C, or anal or ear temperature ≤37.8 ° C, and maintained for 24h or more

Measure: Complete fever time

Time: Up to Day 14

Description: Cough score "day + night" from the beginning of study medication to cough ≤ 1 point, and maintained for 24 hours and above

Measure: Cough relief time

Time: Up to Day 14

Description: From the beginning of the study drug to two consecutive times (sampling interval of at least 1 day)

Measure: Virus negative time

Time: Up to Day 14

Description: Defined as the proportion of subjects exacerbated during treatment and meeting the diagnostic criteria for severe or critical neocoronavirus pneumonia

Measure: Incidence of severe or critical neocoronavirus pneumonia

Time: Up to Day 14

37 A Pilot Study of Bevacizumab in the Treatment of Severe or Critical Patients With COVID-19 Pneumonia (BEST-CP)

The novel identified coronavirus (SARS-CoV-2) in 2019 causes an nationwide outbreak as well as public health crisis in China, and expands globally. Pulmonary edema is one of the most detrimental symptoms and usually presents in severe and critical coronavirus disease (COVID-19), resulting in dyspnea, acute lung injury (ALI) ,acute respiratory distress syndrome (ARDS), and even death. Recent evidence revealed higher levels of blood Vascular Endothelial Growth Factor (VEGF) in COVID-19 patients compared with healthy controls. VEGF is considered as the most potent vascular permeability inducers. Numerous studies have revealed that VEGF was a key factor and a potential therapeutic target in ALI and ARDS. Bevacizumab, an anti-VEGF drug, approved by the FDA on February 26, 2004 and widely used in clinical oncotherapy, is a promising drug for ALI/ARDS in COVID-19 through suppression of pulmonary edema.

NCT04275414 Coronavirus Infections Drug: Bevacizumab Injection

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio

Measure: Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio

Time: 24 hours

Description: Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio

Measure: Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio

Time: 72 hours

Description: Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio

Measure: Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio

Time: 7 days

Secondary Outcomes

Description: Liker scale: The patient grades his current breathing compared to when he first started the drug (from -3 to 3). "0" = no change, "1" =minimally better, "2" =moderately better, "3" =markedly better, "-1" =minimally worse, "-2" =moderately worse, "-3" =markedly worse

Measure: Degree of dyspnea (Liker scale)

Time: 72 hours

Description: The patient grades the current breathing condition of himself compared to when he first started the drug (from -3 to 3).

Measure: Degree of dyspnea (Liker scale)

Time: 7 days

Description: Visual analog scale (VAS): The patient draws a horizontal line on an axial graph (from 0 to 100) to show the degree of how he feels about breathing. The number "0" equals the worst breathing the patient has ever felt and the number "100" equals the best he has ever felt.

Measure: Degree of dyspnea (VAS)

Time: 72 hours

Measure: Degree of dyspnea (VAS)

Time: 7 days

Description: The degree of exudation on Chest CT

Measure: The area of lung lesions on Chest CT

Time: 7 days

Description: The degree of lung exudation on Chest CT

Measure: The degree of lung exudation on Chest CT

Time: 7 days

Description: transcutaneous oxygen saturation

Measure: SpO2

Time: 24 hours

Description: transcutaneous oxygen saturation

Measure: SpO2

Time: 72 hours

Description: transcutaneous oxygen saturation

Measure: SpO2

Time: 7 days

Description: Partial arterial oxygen pressure

Measure: PaO2

Time: 24 hours

Description: Partial arterial oxygen pressure

Measure: PaO2

Time: 72 hours

Description: Partial arterial oxygen pressure

Measure: PaO2

Time: 7 days

Description: CRP

Measure: CRP

Time: 72 hours

Description: CRP

Measure: CRP

Time: 7 days

Description: hs-CRP

Measure: hs-CRP

Time: 72 hours

Description: hs-CRP

Measure: hs-CRP

Time: 7 days

Description: All-cause mortality

Measure: All-cause mortality

Time: 7 days

Description: All-cause mortality

Measure: All-cause mortality

Time: 14 days

38 An Open-label Randomized Controlled Trial on Lopinavir/ Ritonavir, Ribavirin and Interferon Beta 1b Combination Versus Lopinavir/ Ritonavir Alone, as Treatment for 2019 Novel Coronavirus Infection

A combination of lopinavir/ ritonavir, ribavirin and interferon beta-1b will expedite the recovery, suppress the viral load, shorten hospitalisation and reduce mortality in patients with 2019-n-CoV infection compared with to lopinavir/ ritonavir

NCT04276688 Novel Coronavirus Infection Drug: Lopinavir/ritonavir Drug: Ribavirin Drug: Interferon Beta-1B

MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Time to negative NPS 2019-n-CoV RT-PCR

Measure: Time to negative NPS

Time: Up to 1 month

Secondary Outcomes

Description: Time to negative saliva 2019-n-CoV RT-PCR

Measure: Time to negative saliva

Time: Up to 1 month

Description: Time to NEWS of 0

Measure: Time to clinical improvement

Time: Up to 1 month

Description: Length of hospitalisation

Measure: Hospitalisation

Time: Up to 1 month

Description: 30-day mortality

Measure: Mortality

Time: Up to 1 month

Description: Cytokine/ chemokine changes

Measure: Immune reaction

Time: up to 1 month

Description: Adverse events during treatment

Measure: Adverse events

Time: up to 1 month

Description: Time to negative NPS, saliva, urine and stool 2019-n-CoV RT-PCR

Measure: Time to negative all clinical specimens

Time: up to 1 month

39 A Pilot Clinical Study on Aerosol Inhalation of the Exosomes Derived From Allogenic Adipose Mesenchymal Stem Cells in the Treatment of Severe Patients With Novel Coronavirus Pneumonia

In December 2019, a novel coronavirus infectious disease characterized by acute respiratory impairment due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) broke out in Wuhan city of Hubei province in China. So far no specific antiviral therapy can be available for patients with SARS-CoV-2 infection. Although symptomatic and supportive care, even with mechanical ventilation or extracorporeal membrane oxygenation (ECMO), are strongly recommended for severe infected individuals, those with advancing age and co-morbidities such as diabetes and heart disease remain to be at high risk for adverse outcomes. This pilot clinical trial will be performed to explore the safety and efficiency of aerosol inhalation of the exosomes derived from allogenic adipose mesenchymal stem cells (MSCs-Exo) in severe patients with novel coronavirus pneumonia (NCP).

NCT04276987 Coronavirus Biological: MSCs-derived exosomes

MeSH:Coronavirus Infections Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: Safety evaluation within 28 days after first treatment, including frequency of adverse reaction (AE) and severe adverse reaction (SAE)

Measure: Adverse reaction (AE) and severe adverse reaction (SAE)

Time: Up to 28 days

Description: Efficiency evaluation within 28 days, including time to clinical improvement (TTIC)

Measure: Time to clinical improvement (TTIC)

Time: Up to 28 days

Secondary Outcomes

Description: Number of patients weaning from mechanical ventilation within 28 days

Measure: Number of patients weaning from mechanical ventilation

Time: Up to 28 days

Description: Duration (days) of ICU monitoring within 28 days

Measure: Duration (days) of ICU monitoring

Time: Up to 28 days

Description: Duration (days) of vasoactive agents using within 28 days

Measure: Duration (days) of vasoactive agents usage

Time: Up to 28 days

Description: Duration (days) of mechanical ventilation supply among survivors

Measure: Duration (days) of mechanical ventilation supply

Time: Up to 28 days

Description: Number of patients with improved organ failure within 28 days, including cardiovascular system, coagulation system, liver, kidney and other extra-pulmonary organs

Measure: Number of patients with improved organ failure

Time: Up to 28 days

Description: Rate of mortality within 28 days

Measure: Rate of mortality

Time: Up to 28 days

Other Outcomes

Description: Records of daily sequential organ failure assessment (SOFA) score (From 0 to 24 points, higher scores mean a worse outcome)

Measure: Sequential organ failure assessment (SOFA) score

Time: Every day for 28 days

Description: Records of Blood routine test

Measure: Lymphocyte Count (10E9/L)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Measure: C-reactive protein (CRP) (mg/L)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Measure: Lactate dehydrogenase (U/L)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Description: Coagulation function

Measure: D-dimer (mg/L)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Description: Records of heart failure

Measure: pro-type B natriuretic peptide (pro-BNP) (pg/ml)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Description: Record of serum cytokine

Measure: IL-1β (pg/ml)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Description: Record of serum cytokine

Measure: IL-2R (ng/L)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Description: Record of serum cytokine

Measure: IL-6 (ng/L)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Description: Record of serum cytokine

Measure: IL-8 (ng/L)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Description: Computed tomography or X-ray

Measure: Chest imaging

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Description: Time to SARS-CoV-2 RT-PCR negativity in respiratory tract specimens

Measure: Time to SARS-CoV-2 RT-PCR negativity

Time: Up to 28 days

40 Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

NCT04278404 Coronavirus Infection (COVID-19) Pulmonary Arterial Hypertension Urinary Tract Infections in Children Hypertension Pain Hyperphosphatemia Primary Hyperaldosteronism Edema Hypokalemia Heart Failure Hemophilia Menorrhagia In Insomnia Pneumonia Skin Infection Arrythmia Asthma in Children Bronchopulmonary Dysplasia Adrenal Insufficiency Fibrinolysis; Hemorrhage Attention Deficit Hyperactivity Disorder Multisystem Inflammatory Syndrome in Children (MIS-C) Kawasaki Disease Coagulation Disorder Down Syndrome Drug: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:

MeSH:Infection Communicable Diseases Urinary Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Bronchopulmonary Dysplasia Down Syndrome Menorrhagia Hypertension Hemostatic Disorders Mucocutaneous Lymph Node Syndrome Blood Coagulation Disorders Hyperphosphatemia Hypokalemia Adrenal Insufficiency Hyperaldosteronism Disease Syndrome Hemorrhage Attention Deficit Disorder with Hyperactivity

HPO:Abnormality of coagulation Abnormality of the coagulation cascade Adrenal insufficiency Attention deficit hyperactivity disorder Hyperaldosteronism Hyperphosphatemia Hypertension Hypokalemia Menorrhagia Primary hyperaldosteronism

Primary Outcomes

Measure: Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling

Measure: Elimination rate constant (ke) as measured by PK sampling

Measure: Half-life (t1/2) as measured by PK sampling

Measure: Absorption rate constant (ka) as measured by PK sampling

Measure: AUC (area under the curve) as measured by PK sampling

Measure: Maximum concentration (Cmax) as measured by PK sampling

Measure: Time to achieve maximum concentration (Tmax) as measured by PK sampling

41 Investigation on Clinical Features of Suspected and Confirmed Patients of 2019 Novel Coronavirus Infection in Isolation Unit

Outbreak of 2019 Novel Coronavirus infection started in Wuhan and quickly spread to the world. Suspected patients were isolated and treated in our department. Clinical data was recorded to investigate the clinical features of patients confirmed and excluded diagnosed of 2019 Novel Coronavirus infection.

NCT04279782 Coronavirus Other: Comprehensive treatment

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: If the patient will survive after comprehensive treatment

Measure: Survival rate

Time: 28 days

Secondary Outcomes

Description: Images of chest computed tomography are obtained to find out the changes in the course of treatment

Measure: Chest computed tomography

Time: 28 days

Description: Time for recovery from admission to discharged

Measure: Recovery Time

Time: 28 days

Description: A self-rating depression scale (SCL-90) will be finished from patients and medical staff. There are 90 questions. Each question scores from 1 to 5. Minimum score is 90, maximun score is 450. High scores indicate poor condition.

Measure: Depression evaluation

Time: 28 days

42 Study on Detection of 2019 Novel Coronavirus in Multiple Organ System and Its Relationship With Clinical Manifestations in Patients

Outbreak of 2019 Novel Coronavirus infection quickly spread to the world. Confirmed patients were isolated and treated in our department. 2019 Novel Coronavirus was detected in multiple organ system. Clinical data was recorded to investigate the its relationship with viral detection.

NCT04279795 Coronavirus

MeSH:Coronavirus Infections

Primary Outcomes

Description: rate of positive results of detection 2019 Novel Coronavirus nucleic acid from urine, blood, anal swabs and pharyngeal swabs samples

Measure: Positive rate of 2019 Novel Coronavirus RNA

Time: 28 days

Secondary Outcomes

Description: If the patient will survive after comprehensive treatment

Measure: Survival rate

Time: 28 days

43 Clinical Investigation of Natural Killer Cells Treatment in Pneumonia Patients Infected With 2019 Novel Coronavirus

Since december 2019, acute respiratory disease due to 2019 novel coronavirus (2019-nCoV) emerged in Wuhan city and rapidly spread throughout China. There is no confirmed antivirus therapy for 2019-nCoV infection. Natural killer (NK) cells are innate lymphocytes that may serve as useful effectors against danger infection. The purpose of this clinical investigation is to evaluate the safety and efficiency of NK Cells in combination with standard therapy for pneumonia patients infected with 2019-nCoV.

NCT04280224 Novel Coronavirus Pneumonia Biological: NK Cells

MeSH:Coronavirus Infections Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: Evaluation of pneumonia improvement

Measure: Improvement of clinical symptoms including duration of fever

Time: Measured from day 0 through day 28

Description: Evaluation of pneumonia improvement

Measure: Improvement of clinical symptoms including respiratory frequency

Time: Measured from day 0 through day 28

Description: Safety evaluation

Measure: Number of participants with treatment-related adverse events evaluated with CTCAE,version 4.0

Time: Measured from day 0 through day 28

Secondary Outcomes

Description: Marker for 2019-nCoV

Measure: Time of virus nucleic acid test negative

Time: Measured from day 0 through day 28

Description: Marker of immunological function

Measure: CD4+ and CD8+ T cell count

Time: Measured from day 0 through day 28

Description: Marker for efficacy of treatment

Measure: Rate of mortality within 28-days

Time: Day 28

Description: Recovery of lung injury

Measure: Size of lesion area by thoracic imaging

Time: Measured from day 0 through day 28

44 Efficacy of Fingolimod in the Treatment of New Coronavirus Pneumonia (COVID-19)

Although immune-inflammatory treatment is not routinely recommended to be used for SARS-CoV-2 pneumonia, according to the pathological findings of pulmonary oedema and hyaline membrane formation, timely and appropriate use of immune modulator together with ventilator support should be considered for the severe patients to prevent ARDS development. The sphingosine-1-phosphate receptor regulators Fingolimod (FTY720) is an effective immunology modulator which has been widely used in multiple sclerosis.The aim of this study was to determine whether the efficacy of fingolimod for a novel coronavirus disease (COVID-19).

NCT04280588 Coronavirus Disease (COVID-19) Drug: Fingolimod 0.5 mg

MeSH:Coronavirus Infections

Primary Outcomes

Description: The lesion change on X-ray images from day 5 to baseline

Measure: The change of pneumonia severity on X-ray images

Time: 5 day after fingolimod treatment

45 Clinical Outcomes of Hospitalized Patients With Coronavirus Disease 2019

As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.

NCT04280913 Coronavirus Disease 2019 Other: retrospective analysis

MeSH:Coronavirus Infections

Primary Outcomes

Description: The primary outcome is the time to negative conversion of coronavirus

Measure: Time to negative conversion of severe acute respiratory syndrome coronavirus 2

Time: 1 month

Secondary Outcomes

Description: The time of hospitalization.

Measure: Length of stay in hospital

Time: 1 month

Description: The rate of survival within hospitalization of these patients will be tracked.

Measure: Survival

Time: 1 month

Description: The rate of intubation within hospitalization of these patients will be tracked.

Measure: Intubation

Time: 1 month

46 Identification of a New Screening Strategy for 2019 Novel Coronavirus Infection

Since Dec 2019, over 70000 novel coronavirus infection pneumonia (NCIP) patients were confirmed. 2019 novel coronavirus (2019 nCoV) is a RNA virus, which spread mainly from person-to-person contact. Most of the symptoms are non-specific, including fever, fatigue, dry cough. Sever NCIP patients may have shortness of breath and dyspnea, and progress to acute respiratory distress syndrome (ARDS) and multiple organ dysfunction syndrome (MODS). The mortality is reported to be around 2.3%. Thus, early detection and early treatment is very important to the improvement of NCIP patients' prognosis. At present, NCIP RNA detection of pharyngeal swab specimen by RT-PCR is recommended. However, due to the universal susceptibility to 2019 nCoV in general population and limited number of NCIP RNA detection kits available, to identify an efficient screening strategy is urgently needed. This study aim to develop and validate the diagnostic accuracy and screening efficiency of a new NCIP screening strategy, which can benefit the disease prevention and control.

NCT04281693 Novel Coronavirus Infection Pneumonia Diagnostic Test: Standard screening strategy Diagnostic Test: New screening strategy

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: The screening accuracy of the two screening strategies were calculated and compared.

Measure: Screening accuracy

Time: 1 month

Secondary Outcomes

Description: The costs of the two screening strategies were recorded. Cost-effectiveness analysis were performed and compared.

Measure: Cost-effectiveness analysis

Time: 1 month

47 A Randomized, Open-label Study to Evaluate the Efficacy and Safety of Pirfenidone in Patients With Severe and Critical Novel Coronavirus Infection

The acute lung injury caused by SARS and 2003 were both related to the inflammatory cytokine storm in patients. The biochemical test showed abnormal increase in related indicators such as interleukin-8, and CT images showed a medical "white" lung". According to the experience of SARS treatment in 2003, the use of hormones will indeed help the patients to alleviate their illness, but patients who survived SARS either had too much hormone at that time and took too long. Although the lungs could recover, but the femoral head was necrotic Either the amount of hormones was very conservative at the time, which kept the lungs in the storm of inflammatory factors, leading to the emergence of irreversible pulmonary fibrosis. So is there a medicine that can anti-inflammatory, reduce the load of hormone use, and have the effect of treating and preventing pulmonary fibrosis complicated by severe viral lung? At present, pirfenidone has achieved encouraging results in the treatment of idiopathic Pulmonary Fibrosis (CTD-ILD) diseases. It is particularly encouraging that the values announced at the 2019 ATS Annual Conference suggest that pirfenidone has more anti-inflammatory and anti-oxidant effects than its own outstanding anti-fibrotic ability. The data shows early use, Its strong anti-SOD activity can effectively inhibit IL-1beta and IL-4, and can open the prevention mode of pulmonary interstitial fibrosis. Based on the above, this project intends to make the following scientific assumptions: based on the homology of the pathogens of the new coronavirus-infected pneumonia and the coronavirus infection of pneumonia in 2003, the similarities in the occurrence and development of the disease, that is, the pulmonary inflammatory storm occurs first, and thereafter The progress of fibrosis and the progressive decline of lung function and mortality are higher than those of ordinary pneumonia. We hope that by adding pirfenidone as a treatment program in addition to standard treatment, it will be a new and severe type of coronavirus infection. Patient clinical treatment provides an effective and practical method.

NCT04282902 Novel Coronavirus Pneumonia Pneumonia Pirfenidone Drug: pirfenidone

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: Lesion area of chest CT image at 4 weeks

Measure: chest CT

Time: 4 weeks

Description: Absolute change in pulse oxygen from baseline

Measure: Finger pulse oxygen

Time: 4 weeks

Description: Absolute change in blood gas from baseline

Measure: blood gas

Time: 4 weeks

Description: Absolute change in total score of King's brief questionnaire for interstitial Absolute change in total score of King's brief questionnaire for interstitial pulmonary disease (k-bild) from baseline at week 4

Measure: K-BILD

Time: 4 weeks

Secondary Outcomes

Description: Time to death within 4 weeks due to respiratory problems

Measure: death

Time: 4 weeks

Description: Time to disease progression or death within 4 weeks

Measure: Time to disease progression or death within 4 weeks

Time: 4 weeks

Description: lymphocyte count

Measure: blood

Time: 4 weeks

Description: Absolute change in viral nucleic acid from baseline

Measure: viral nucleic acid

Time: 4 weeks

Description: Pulmonary fibrosis survival symptoms absolute changes in dyspnea score from baseline

Measure: dyspnea score

Time: 4 weeks

Description: changes in blood inflammatory indexes

Measure: blood

Time: 4 weeks

Description: Absolute change in cough scores for pulmonary fibrosis survival symptoms from baseline

Measure: cough scores

Time: 4 weeks

48 Study for Clinical Epidemiology and Methods of Diagnosis and Treatment of Novel Coronavirus Pneumonia (NCP)

To develop practical and effective clinical diagnosis and treatment schemes for the control of novel coronavirus pneumonia.

NCT04283396 Novel Coronavirus Pneumonia Combination Product: systemic treatment

MeSH:Coronavirus Infections Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: Number of patients recover from novel coronavirus pneumonia

Measure: recovery

Time: up to 24 weeks

49 The Therapeutic Efficacy of Psychological and Physical Rehabilitation Based Humanistic Care in Patients With Coronavirus Disease 2019

As of February 17th, 2020, China has 76396 confirmed cases of coronavirus disease 2019 (COVID-19), including 2348 deaths. Although the impact factors of clinical outcomes among hospitalized patients still need to be clarified, some of the therapeutic regimens have shown the potency in the treatment of severe cases. Investigators aim to evaluate the efficacy of psychological and physical rehabilitation based humanistic care in the treatment of COVID-2019.

NCT04283825 Coronavirus Disease 2019 Behavioral: Psychological and physical rehabilitation based humanistic care

MeSH:Coronavirus Infections

Primary Outcomes

Description: Time for recovery from admission to discharged

Measure: Recovery Time

Time: 1 month

Secondary Outcomes

Description: Self-rating depression scale will be finished from patients by a scale table designed by investigator

Measure: Self-rating depression scale

Time: 1 month

Description: Survival rate of the patient after treatment

Measure: Survival rate

Time: 1 month

50 The Effect of Humanistic Care in Healthcare Workers Participated in the Treatment of Coronavirus Disease 2019

As of February 17th, 2020, China has 76396 confirmed cases of coronavirus disease 2019 (COVID-19), including 2348 deaths. The impact factors of clinical outcomes among hospitalized patients still need to be clarified. The healthcare workers faced greater mental and physical pressure under long-term, high-intensity, high-risk working conditions. Investigators aim to evaluate the positive effect of humanistic care for healthcare workers participated in the treatment of COVID-19.

NCT04283838 Coronavirus Disease 2019 Behavioral: Humanistic Care

MeSH:Coronavirus Infections

Primary Outcomes

Description: Self-rating depression scale will be finished from healthcare workers by a scale table designed by investigator

Measure: Self-rating depression scale

Time: 1 month

Secondary Outcomes

Description: the incidence of post-traumatic stress disorder in healthcare workers

Measure: Incidence of PTSD

Time: 1 month

51 A Clinical Study to Investigate the Effect of T89 on Improving Oxygen Saturation and Clinical Symptoms in Patients With Coronavirus Disease 2019 (COVID-19)

This is an open-label, randomized, blank-controlled treatment clinical study. The objective of this study is to investigate the effect of T89 on improving oxygen saturation and clinical symptoms in patients with Coronavirus Disease 2019 (COVID-19). In this study, estimated total of 120-240 male and female patients who have been diagnosed with non-critical type of coronavirus pneumonia (COVID-19) will be enrolled and randomly assigned to one of two study groups, the T89 treatment group and the blank control group, to T89 or nothing on the base of a recommended standard treatment for up to 14 days . The primary efficacy parameters include the time to oxygen saturation recovery to normal level (≥97%), the proportion of patients with normal level of oxygen saturation after treatment, and the total duration of oxygen inhalation, oxygen flow change by time, oxygen concentration change by time during treatment.

NCT04285190 Coronavirus Disease 2019 Novel Coronavirus Pneumonia Drug: T89

MeSH:Coronavirus Infections Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: From screening to the end of treatment, for all patients randomized, oxygen saturation will be assessed for 3 times daily, the time to oxygen saturation recovery to normal level (≥97%) will be calculated finally based on that record and compared between two groups.

Measure: The time to oxygen saturation recovery to normal level (≥97%)

Time: Day -1 to 10

Description: The proportion of patients with normal level of oxygen saturation(≥97%) after treatment will be calculated finally based on that record and compared between two groups.

Measure: The proportion of patients with normal level of oxygen saturation(≥97%)

Time: Day -1 to 10

Secondary Outcomes

Description: From screening to the end of treatment, for all patients randomized, the symptoms will be assessed 2 times daily, and the time to achievement of remission for each symptom will be calculated finally based on the record and compared between two groups.

Measure: The degree of remission of symptoms of patients, including: fatigue, nausea, vomiting, chest tightness, shortness of breath, etc.

Time: Day -1 to 10

Description: From screening to the end of treatment, for all patients randomized, myocardial enzyme spectrum will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the myocardial enzyme spectrum recovery to normal will be calculated finally based on the record and compared between two groups.

Measure: The time to the myocardial enzyme spectrum recovery to normal after treatment

Time: Day -1, 3, 7 and 10

Description: From screening to the end of treatment, for all patients randomized, myocardial enzyme spectrum will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal myocardial enzyme spectrum after treatment will be calculated finally based on the record and compared between two groups.

Measure: The proportion of the patients with normal myocardial enzyme spectrum after treatment

Time: Day -1, 3, 7 and 10

Description: From screening to the end of treatment, for all patients randomized, 12-lead electrocardiogram will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the myocardial enzyme spectrum recovery to normal level will be calculated finally based on the record and compared between two groups.

Measure: The time to the electrocardiogram recovery to normal level after treatment

Time: Day -1, 3, 7 and 10

Description: From screening to the end of treatment, for all patients randomized, 12-lead electrocardiogram will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal electrocardiogram will be calculated finally based on the record and compared between two groups.

Measure: The proportion of the patients with normal electrocardiogram after treatment

Time: Day -1, 3, 7 and 10

Description: From screening to the end of treatment, for all patients randomized, the hemodynamics will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the hemodynamics recovery to normal will be calculated finally based on the record and compared between two groups.

Measure: The time to the hemodynamics recovery to normal after treatment

Time: Day -1 and 10

Description: From screening to the end of treatment, for all patients randomized, the hemodynamics will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal hemodynamics will be calculated finally based on the record and compared between two groups.

Measure: The proportion of the patients with normal hemodynamics after treatment

Time: Day -1 and 10

Description: From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The time to exacerbation or remission of the disease will be calculated finally based on the record and compared between two groups.

Measure: The time to exacerbation or remission of the disease after treatment;

Time: Day -1 to 10

Description: From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The proportion of patients whose disease get aggravated or alleviated will be calculated finally based on the record and compared between two groups.

Measure: The proportion of the patients with exacerbation or remission of disease after treatment

Time: Day -1 to 10

Description: From screening to the end of treatment, for all patients randomized, the need for additional treatment will be recorded and compared between two groups.

Measure: The proportion of patients who need other treatment (e.g. heparin, anticoagulants) due to microcirculation disorders

Time: Day -1 to 10

Description: For all patients, the mortality will be recorded in each group and the rate will be compared between two groups.

Measure: The all-cause mortality rate

Time: Day -1 to 10

Description: From screening to the end of treatment, for all patients randomized, the proportion of patients with acidosis will be compared between two groups based on the hemodynamics results.

Measure: The proportion of patients with acidosis

Time: Day -1 and 10

Description: For all patients, the duration of hospitalization will be recorded in each group and compared between two groups.

Measure: The total duration of the patients in-hospital

Time: Day -1 to 10

Description: From screening to the end of treatment, for all patients randomized, the total duration of oxygen inhalation during oxygen treatment will be assessed and compared, if applicable, between two groups.

Measure: The total duration of oxygen inhalation during treatment

Time: Day -1 to 10

Description: From screening to the end of treatment, for all patients randomized, the oxygen flow rate during oxygen treatment will be assessed and compared, if applicable, between two groups.

Measure: The oxygen flow rate during treatment

Time: Day -1 to 10

Description: From screening to the end of treatment, for all patients randomized, the oxygen concentration during oxygen treatment will be assessed and compared, if applicable, between two groups.

Measure: The oxygen concentration during treatment

Time: Day -1 to 10

52 The Efficacy and Safety of Carrimycin Treatment in Patients With Novel Coronavirus Infectious Disease (COVID-19) : A Multicenter, Randomized, Open-controlled Study

The novel coronavirus infectious disease ( COVID-19") induced by novel coronavirus(SARS-CoV-2) in December 2019 has outbreaked in Wuhan. It may lead to epidemic risk in global. As the COVID-19 is an emerging infectious disease, it has not scientifically recognized and has no effective drugs for treatment currently. Therefore, we will launch a scientific project "The efficacy and safety of carrimycin treatment in 520 patients with COVID-19 stratificated clinically: A multicenter, randomized (1:1), open-controlled (one of lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate) study" . We try to establish the criteria for clinical cure and the early predictive model of COVID-19 progression. The primary efficiency outcomes were:(1) Fever to normal time (day); (2) Pulmonary inflammation resolution time (HRCT) (day); and (3)Negative conversion (%) of SARS-CoV-2 RNA at the end of treatment. The secondary efficiency outcomes and adverse events were observed.

NCT04286503 Novel Coronavirus Infectious Disease (COVID-19) Drug: Carrimycin Drug: lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate Drug: basic treatment

MeSH:Communicable Diseases Infection Coronavirus Infections

Primary Outcomes

Description: Fever to normal time (day)

Measure: Fever to normal time (day)

Time: 30 days

Description: Pulmonary inflammation resolution time (HRCT) (day)

Measure: Pulmonary inflammation resolution time (HRCT) (day)

Time: 30 days

Description: Negative conversion (%) of 2019-nCOVRNA in gargle (throat swabs) at the end of treatment

Measure: Negative conversion (%) of 2019-nCOVRNA in gargle (throat swabs) at the end of treatment

Time: 30 days

53 A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Severe COVID-19 Patients

COVID-19 caused clusters of severe respiratory illness and was associated with 2% mortality. No specific anti-viral treatment exists. The mainstay of clinical management is largely symptomatic treatment, with organ support in intensive care for seriously ill patients. Cellular therapy, using mesenchymal stem cells has been shown to reduce nonproductive inflammation and affect tissue regeneration and is being evaluated in patients with ARDS. This clinical trial is to inspect the safety and efficiency of mesenchymal stem cells (MSCs) therapy for severe COVID-19.

NCT04288102 Corona Virus Disease 2019(COVID-19) Biological: UC-MSCs Biological: Saline containing 1% Human serum albumin（solution without UC-MSCs）

MeSH:Coronavirus Infections Virus Diseases

Primary Outcomes

Description: Evaluation of Pneumonia Improvement

Measure: Change in lesion proportion (%) of full lung volume from baseline to day 28.

Time: Day 28

Secondary Outcomes

Description: Evaluation of Pneumonia Improvement

Measure: Change in lesion proportion (%) of full lung volume from baseline to day 10 and 90

Time: Day 10, Day 90

Description: Evaluation of Pneumonia Improvement

Measure: Change in consolidation lesion proportion (%) of full lung volume from baseline to day 10, 28 and 90.

Time: Day 10, Day 28, Day 90

Description: Evaluation of Pneumonia Improvement

Measure: Change in ground-glass lesion proportion (%) of full lung volume from baseline to day 10, 28 and 90.

Time: Day 10, Day 28, Day 90

Description: Evaluation of Pneumonia Improvement

Measure: Pulmonary fibrosis - related morphological features in CT scan at day 90 a. cord-like shadow b. honeycomb-like shadows c. interlobular septal thickening d. intralobular interstitial thickening e. pleural thickening

Time: Day 90

Description: Evaluation of Pneumonia Improvement

Measure: Lung densitometry: Change in total voxel 'weight' in lesion area voxel 'weight'=voxel density (in HU) × voxel volume (in voxel)

Time: Day 10, Day 28, Day 90

Description: Evaluation of Pneumonia Improvement

Measure: Lung densitometry: volumes histogram of lung density distribution (<-750, -750~-300, -300~50, >50) at day 10, 28 and 90.

Time: Day 10, Day 28, Day 90

Description: Clinical improvement defined as a one-point deduction from baseline in a 6 ordinal scale: Not hospitalized; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.

Measure: Time to clinical improvement in 28 days.

Time: Day 28

Description: Evaluation of Pneumonia Improvement

Measure: Oxygenation index( PaO2/FiO2)

Time: Day 6, Day 10, Day 28

Description: Evaluation of Pneumonia Improvement

Measure: Duration of oxygen therapy(days)

Time: Day 28, Day 90

Description: Evaluation of Pneumonia Improvement

Measure: Blood oxygen saturation

Time: Day 6, Day 10, Day 28

Description: Evaluation of Pneumonia Improvement

Measure: 6-minute walk test

Time: Day 28, Day 90

Description: Evaluation of Pneumonia Improvement

Measure: Maximum vital capacity (VCmax)

Time: Baseline, Day 10, Day 14, Day 21, Day 28, Day 90

Description: Evaluation of Pneumonia Improvement

Measure: Diffusing Capacity (DLCO)

Time: Baseline, Day 10, Day 14, Day 21, Day 28, Day 90

Description: Evaluation of Pneumonia Improvement No limitation of activities, discharged from hospital =Score 1; Hospitalized, no oxygen therapy=Score 2; Oxygen by mask or nasal prongs-Score 3; Non-invasive ventilation or high-flow oxygen=Score 4; Mechanical ventilation or ECMO=Score 5; Death=Score 6.

Measure: mMRC (Modified Medical Research Council) dyspnea scale

Time: Day 28, Day 90

Description: Marker of Immunological function

Measure: Changes of absolute lymphocyte counts and subsets from baseline to day 6, 10, 28 and 90.

Time: Day 6, Day 10, Day 28, Day 90

Description: Marker of Immunological function

Measure: Changes of cytokine/chemokine levels from baseline to day 6, 10, 28 and 90.

Time: Day 6, Day 10, Day 28, Day 90

Description: Safety endpoints

Measure: Adverse events

Time: Day 0 through Day 90

Description: Safety endpoints

Measure: Serious adverse events

Time: Day 0 through Day 90

Description: Safety endpoints

Measure: All-cause mortality

Time: Day 0 through Day 90

54 Soliris to Stop Immune Mediated Death In Covid 19 Infected Patients. A Trial of Distal Complement Inhibition.

Covid-19 has spread rapidly throughout the world causing widespread panic, death, and injury. While this virus is the provocateur, it is often the patient's own disproportionate immune response which deals the most devastating (and often fatal) damage. A specific part of the immune system, known as the complement, has been shown to cause such damage in other types of coronaviruses. In the SOLID-C19 study, Soliris (Eculizumab) will be used to modulate the activity of the distal complement preventing the formation of the membrane attack complex. By modulating this portion of the immune response, mortality can be halted while the patient has time to recover from the virus with supportive medical care.

NCT04288713 Coronavirus Drug: Eculizumab

MeSH:Coronavirus Infections

55 Nitric Oxide Gas Inhalation Therapy in Spontaneous Breathing Patients With Mild/Moderate COVID19 Infection: a Randomized Clinical Trial

The scientific community is in search for novel therapies that can help to face the ongoing epidemics of novel Coronavirus (COVID-19) originated in China in December 2019. At present, there are no proven interventions to prevent progression of the disease. Some preliminary data on SARS pneumonia suggest that inhaled Nitric Oxide (NO) could have beneficial effects on COVID-19 due to the genomic similarities between this two coronaviruses. In this study we will test whether inhaled NO therapy prevents progression in patients with mild to moderate COVID-19 disease.

NCT04290858 Coronavirus Infections Pneumonia, Viral Dyspnea Drug: Nitric Oxide

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Dyspnea

HPO:Dyspnea Pneumonia Respiratory distress

Primary Outcomes

Description: The primary outcome will be the proportion of patients with mild COVID2019 who deteriorate to a severe form of the disease requiring intubation and mechanical ventilation. Patients with indication to intubation and mechanical ventilation but concomitant DNI (Do Not Intubate) or not intubated for any other reason external to the clinical judgment of the attending physician will be considered as meeting the criteria for the primary endpoint.

Measure: Reduction in the incidence of intubation and mechanical ventilation

Time: 28 days

Secondary Outcomes

Description: Mortality from all causes

Measure: Mortality

Time: 28 days

Description: Proportion of patients with a negative conversion of RT-PCR from an oropharyngeal or a nasopahryngeal swab

Measure: Negative conversion of COVID-19 RT-PCR from upper respiratory tract

Time: 7 days

Description: Time from initiation of the study to discharge or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air) and alleviation of cough (defined as mild or absent in a patient reported scale of severe >>moderate>>mild>>absent).

Measure: Time to clinical recovery

Time: 28 days

56 Nitric Oxide Gas Inhalation Therapy for Severe Acute Respiratory Syndrome Due to COVID-19.

The investigators will enroll 102 patients with a confirmed diagnosis of COVID-19. Patients will be randomized to receive either inhaled nitric oxide (per protocol) or placebo. ICU Standards of care will be the institution's own protocols (such as ventilation strategies and use and dose of antivirals and antimicrobials, steroids, inotropic and vasopressor agents).

NCT04290871 Coronavirus SARS (Severe Acute Respiratory Syndrome) Drug: Nitric Oxide Gas

MeSH:Coronavirus Infe Coronavirus Infections Severe Acute Respiratory Syndrome Syndrome

Primary Outcomes

Description: Percentage of patients that have a PaO2/FiO2 ratio steadily > 300 in ambient air

Measure: SARS-free patients at 14 days

Time: 14 days since beginning of treatment

Secondary Outcomes

Measure: Survival at 28 days

Time: 28 days

Measure: Survival at 90 days

Time: 90 days

Description: Composite outcome in which: Death=0, Days of treatment =1

Measure: SARS-free days at 28 days

Time: 28 days

Description: Composite outcome in which: Death=0, Days of treatment =1

Measure: SARS -free days at 90 days

Time: 90 days

Description: Incidence

Measure: Renal Replacement Therapy

Time: 28 days

Description: Incidence

Measure: Liver Failure

Time: 28 days

Description: Incidence of patients requiring VA-ECMO, LVAD, IABP

Measure: Mechanical Support of Circulation

Time: 28 days

Description: In ambient air if possible

Measure: PaO2/FiO2 ratio in ambient air

Time: daily for 28 days

57 Clinical Progressive Characteristics and Treatment Effects of 2019-novel Coronavirus(2019-nCoV)

Objects: The purpose of this study was to observe the characteristics of morbidity, disease progression and therapeutic effects of 2019-novel coronavirus pneumonia patients with different clinical types. Method: A single center, retrospective and observational study was used to collect COVID-19 patients admitted to Wuhan Infectious Diseases Hospital (Wuhan JinYinTan Hospital) from January 2020 to March 2020. The general information, first clinical symptoms, hospitalization days, laboratory examination, CT examination, antiviral drugs, immune enhancers, traditional Chinese medicine treatment and other clinical intervention measures were recorded, and the nutritional status and prognosis of the patients were recorded. confirm COVID-19 's disease progression, clinical characteristics, disease severity and treatment effects. To compare the characteristics of disease progression, clinical features, disease severity and therapeutic effect of different types of COVID-19. Outcomes: The characteristics of disease progression, clinical features, disease severity and therapeutic effect of different types of COVID-19. Conclusion: The characteristics of disease progression, clinical features and therapeutic effect of different types of COVID-19.

NCT04292327 Pneumonia Caused by Human Coronavirus

MeSH:Coronavirus Infections Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: The mortality of COVID-19 in 28 days

Measure: Mortality

Time: 28 day

Description: The time interval of COVID-19 form nucleic acid confirmed to the nucleic acid detection turn into negative.

Measure: The time interval of Nucleic acid detection become negative

Time: 28 day

58 The Efficacy and Safety of Anti-SARS-CoV-2 Inactivated Convalescent Plasma in the Treatment of Novel Coronavirus Pneumonia Patient (COVID-19) : An Observational Study

There is still no effective antiviral drugs and vaccines against SARS-CoV-2 yet now. This is an obsevational study, the investigators collected the clinical information and clinical outcomes of the COVID-19 patients using anti-2019-nCoV inactivated convalescent plasma.The study is to evaluate the efficacy and safety of anti-2019-nCoV inactivated convalescent plasma in the treatment of COVID-19 pneumonia.

NCT04292340 Coronavirus

MeSH:Coronavirus Infections

Primary Outcomes

Description: The SARS-CoV-2 nuclei acid was quantified using RT-PCR

Measure: The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 1

Time: 1 day after receiving plasma transmission

Measure: The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3

Time: 3 days after receiving plasma transmission

Measure: The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7

Time: 7 days after receiving plasma transmission

Description: Clinical outcomes include death, critical illness, recovery

Measure: Numbers of participants with different Clinical outcomes

Time: From receiving plasma transmission to 4 weeks

Secondary Outcomes

Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Time: 4 weeks after receiving plasma transmission

59 Randomized, Open, Blank Control Study on the Efficacy and Safety of Recombinant Human Interferon α1β in the Treatment of Patients With New Type of Coronavirus Infection in Wuhan

New coronavirus infection is an important cause of public health emergencies at home and abroad, which seriously affects people's health and social stability. The outbreak of SRAR-COV in China in 2003 caused serious social impact. From January 2002 to August 7, 2003, there were a total of 8,422 cases worldwide, involving 32 countries and regions, of which 919 cases were fatal, with a fatality rate of nearly 11%. The fatality rate of elderly patients and patients with underlying diseases was even more high.There is no precise and effective treatment for coronavirus infection. In vitro, IFN-α2β has inhibitory effects on MERS-CoV and closely related coronavirus severe acute respiratory syndrome (SARS) -CoV. A study showed the effects of interferon-α2β and ribavirin on the replication of nCoV isolates hCoV-EMC / 2012 in Vero and LLC-MK2 cells. The combined application may be useful for the management of patients with nCoV infection in the future. At present, the combination therapy of interferon α2β and ribavirin has been successfully applied in the initial treatment and prevention of SARS and MERS.The purpose of this study was to evaluate the efficacy and safety of recombinant human interferon α1β in treating patients with new coronavirus infection in Wuhan.

NCT04293887 COVID-19 Recombinant Human Interferon α1β Drug: Recombinant human interferon α1β

MeSH:Coronavirus Infections

Primary Outcomes

Description: dyspnea

Measure: The incidence of side effects

Time: Within 14 days after enrollment

Description: SPO2≤94%

Measure: The incidence of side effects

Time: Within 14 days after enrollment

Description: respiratory rate ≥24 breaths/min in oxygen state)

Measure: The incidence of side effects

Time: Within 14 days after enrollment

Secondary Outcomes

Description: the patient had a normal body temperature of > for 24 hours (without taking antipyretic drugs or hormones) without self-consciousness Dyspnea or reduced dyspnea;

Measure: Time from patient enrollment to clinical remission

Time: Within 14 days after enrollment

Description: Proportion of patients with normal body

Measure: Proportion of patients with normal body

Time: Within 14 days after enrollment

Description: Proportion of patients without dyspnea

Measure: Proportion of patients without dyspnea

Time: Within 14 days after enrollment

Description: Proportion of patients without cough

Measure: Proportion of patients without cough

Time: Within 14 days after enrollment

Description: Proportion of patients without oxygen treatment

Measure: Proportion

Time: Within 14 days after enrollment

Description: The negative conversion rate of new coronavirus nucleic acid

Measure: The negative conversion rate of new coronavirus nucleic acid

Time: Within 14 days after enrollment

Description: Proportion of patients hospitalized/hospitalized in ICU

Measure: Proportion

Time: within 28 days after enrollment

Description: Frequency of serious adverse drug events.

Measure: Frequency of serious adverse drug events.

Time: within 28 days after enrollment

60 Multicenter Clinical Study on the Efficacy and Safety of Xiyanping Injection in the Treatment of New Coronavirus Infection Pneumonia (General and Severe)

In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a real-time reverse transcription PCR (real time RT-PCR) diagnostic assay. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Xiyanping injection has anti-inflammatory and immune regulation effects. This study is a Randomized, Parallel Controlled Clinical Study to treat patients with COVID-19 infection.

NCT04295551 COVID-19 Drug: Lopinavir / ritonavir tablets combined with Xiyanping injection Drug: Lopinavir/ritonavir treatment

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: The time from study drug use to complete fever reduction and cough recovery is measured in hours.

Measure: Clinical recovery time

Time: Up to Day 28

61 Medical Masks Versus N95 Respirators to Prevent 2019 Novel Coronavirus Disease (COVID-19) in Healthcare Workers: A Randomized Trial

A randomized controlled trial in which nurses will be randomized to either medical masks or N95 respirators when providing care to patients with COVID-19.

NCT04296643 Coronavirus N95 Medical Mask Device: Medical Mask Device: N95 respirator

MeSH:Coronavirus Infections

Primary Outcomes

Description: Number of participants with RT-PCR confirmed COVID-19 infection

Measure: RT-PCR confirmed COVID-19 infection

Time: 6 months

Secondary Outcomes

Description: Number of participants with acute respiratory illness

Measure: Acute respiratory illness

Time: 6 months

Description: Number of participants with absenteeism

Measure: Absenteeism

Time: 6 months

Description: Number of participants with lower respiratory infection

Measure: Lower respiratory infection

Time: 6 months

Description: Number of participants with pneumonia

Measure: Pneumonia

Time: 6 months

Description: Number of participants with ICU admission

Measure: ICU admission

Time: 6 months

Description: Number of participants needing mechanical ventilation

Measure: Mechanical ventilation

Time: 6 months

Description: Number of participants that died

Measure: Death

Time: 6 months

62 Clinical Application of Stem Cell Educator Therapy for the Treatment of Viral Inflammation Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Currently, the growing epidemic of a new coronavirus infectious disease (Covid-19) is wreaking havoc worldwide, which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SARS-CoV-2 is a RNA virus that display high similarity in both genomic and proteomic profiling with SARS-CoV that first emerged in humans in 2003 in China. Therefore, preventing and controlling the pandemic occurrences are extremely urgent as a global top priority. Due to the lack of effective antiviral drugs, patients may be treated by only addressing their symptoms such as reducing fever. Clinical autopsies from SARS-CoV-infected patients demonstrated that there were major pathological changes in the lungs, immune organs, and small systemic blood vessels with vasculitis. However, the detection of SARS-CoV were primarily found in the lung and trachea/bronchus, but was undetectable in spleen, lymph nodes, bone marrow, heart and aorta, highlighting the overreaction of immune responses induced by viral infection were really harmful, resulting in the pathogenesis of lungs, immune organs, and small systemic blood vessels. To this respect, immune modulation strategy may be potentially beneficial to enhance anti-viral immunity and efficiently reduce the viral load, improve clinical outcomes, expedite the patient recovery, and decline the rate of mortality in patients after being infected with SARS-CoV-2. Tianhe Stem Cell Biotechnologies Inc. has developed a novel globally-patented Stem Cell Educator (SCE) technology designed to reverse the autoimmune response in Type 1 diabetes (T1D), Alopecia Areata (AA) and other autoimmune diseases. SCE therapy uses human multipotent cord blood stem cells (CB-SC) from human cord blood. Their properties distinguish CB-SC from other known stem cell types, including mesenchymal stem cells (MSC) and hematopoietic stem cells (HSC). Several clinical studies show that SCE therapy functions via CB-SC induction of immune tolerance in autoimmune T cells and restore immune balance and homeostasis in patients with T1D, AA and other inflammation-associated diseases. To correct the overreaction of overreaction of immune responses, the investigators plan to treat SARS-CoV-2 patients with Stem Cell Educator therapy.

NCT04299152 Severe Acute Respiratory Syndrome (SARS) Pneumonia Combination Product: Stem Cell Educator-Treated Mononuclear Cells Apheresis

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia Syndrome Inflammation

HPO:Pneumonia

Primary Outcomes

Description: The feasibility will be evaluated by the number of Covid-19 patients who were unable to complete SCE Therapy.

Measure: Determine the number of Covid-19 patients who were unable to complete SCE Therapy

Time: 4 weeks

Secondary Outcomes

Description: Measurements of immune markers' changes will be preformed by flow cytometry such as activated T cells. Peripheral blood mononuclear cells (PBMC) will be collected at 1, 3, 6, 9, 12, 28 day post the SCE therapy.

Measure: Examine the percentage of activated T cells after SCE therapy by flow cytometry

Time: 4 weeks

Description: Measurements of immune marker's changes will be preformed by flow cytometry such as the percentage of Th17 cells. Peripheral blood mononuclear cells (PBMC) will be collected at 1, 3, 6, 9, 12, 28 day post the SCE therapy.

Measure: Assess the percentage of Th17 cells after SCE therapy by flow cytometry

Time: 4 weeks

Description: Patients will be monitored for their chest imaging every 3 - 5 days for 4 weeks after receiving SCE therapy.

Measure: Chest imaging changes by computed tomography (CT) scan of the chest

Time: 4 weeks

Description: To determine the viral load by real time RT-PCR, samples of blood, sputum, nose / throat swab will be collected from patients during the follow-up studies after receiving SCE therapy.

Measure: Quantification of the SARS-CoV-2 viral load by real time RT-PCR

Time: 4 weeks

63 Intermediate-Size Patient Population Expanded Access Treatment Protocol for Coronavirus Disease 2019 (COVID-19) Remdesivir (RDV; GS-5734™)

Disease caused by 2019 Novel Coronavirus also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

NCT04302766 Coronavirus Disease 2019 Drug: Remdesivir

MeSH:Coronavirus Infections

64 Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting; a Randomised, Placebo-controlled Prophylaxis Study (COPCOV)

The study is a double-blind, randomised, placebo-controlled trial that will be conducted in healthcare settings and other facilities directly involved in COVID-19 case management. We will recruit healthcare workers and other staff working in a facility where there are cases of either proven, or suspected, COVID-19, who can be followed reliably for 5 months. 40,000 participants will be recruited and we predict an average of 400-800 participants per site in 50-100 sites. The participant will be randomised to receive either chloroquine or placebo (1:1 randomisation), or to hydroxychloroquine or placebo (1:1 randomisation). A loading dose of 10mg base/kg (four 155mg tablets for a 60kg subject), followed by 155 mg daily (250mg chloroquine phosphate salt/ 200mg hydroxychloroquine sulphate) will be taken for 3 months. If the participant is diagnosed with COVID-19, they will take continue to take the study medication until: - 90 days after enrolment (i.e., completion of kit) - hospitalised due to COVID-19 disease (i.e., not for quarantine purposes) in which case they will stop, or - advised to stop by their healthcare professional for other reasons Episodes of symptomatic respiratory illness, including symptomatic COVID-19, and clinical outcomes will be recorded in the Case Record Form during the follow-up period.

NCT04303507 COVID19 Coronavirus Acute Respiratory Illnesses Drug: Chloroquine or Hydroxychloroquine Drug: Placebo

MeSH:Coronavirus Infections

Primary Outcomes

Description: Number of symptomatic COVID-19 infections will be compared between the chloroquine or hydroxychloroquine and placebo groups

Measure: Number of symptomatic COVID-19 infections

Time: Approximately 90 days

Secondary Outcomes

Description: Symptoms severity of COVID-19 will be compared between the two groups using a respiratory severity score.

Measure: Symptoms severity of COVID-19

Time: Approximately 90 days

Description: Number of asymptomatic cases of COVID-19 will be determined by comparing serology in all participants at time of enrolment and at the end of follow up.

Measure: Number of asymptomatic cases of COVID-19

Time: Approximately 90 days

Description: Number of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.

Measure: Number of symptomatic acute respiratory illnesses

Time: Approximately 90 days

Description: Severity of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.

Measure: Severity of symptomatic acute respiratory illnesses

Time: Approximately 90 days

Other Outcomes

Description: Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, Acute Respiratory Infection and disease severity.

Measure: Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, ARI and disease severity.

Time: Approximately 90 days

Description: Number of days lost to work in relation to the treatment arm

Measure: Assess the impact of chloroquine or hydroxychloroquine prophylaxis on number of days lost to work during the pandemic.

Time: Approximately 90 days

Description: The trial will collect data on monetary costs associated with the use of healthcare resources and determine the effects between treatment groups.

Measure: Assess the impact of chloroquine or hydroxychloroquine prophylaxis on healthcare costs

Time: Approximately 90 days

Description: The trial will collect data on health-related quality of life using the quality of life questionnaire (EQ-5D-3L) to determine the effects between treatment groups.

Measure: Assess the impact of chloroquine or hydroxychloroquine prophylaxis on quality of life measures using the quality of life questionnaire (EQ-5D-3L)

Time: Approximately 90 days

65 Nitric Oxide Gas Inhalation Therapy in Spontaneous Breathing Patients With Mild/Moderate COVID-19: a Randomized Clinical Trial

The scientific community is in search for novel therapies that can help to face the ongoing epidemics of novel Coronavirus (SARS-Cov-2) originated in China in December 2019. At present, there are no proven interventions to prevent progression of the disease. Some preliminary data on SARS pneumonia suggest that inhaled Nitric Oxide (NO) could have beneficial effects on SARS-CoV-2 due to the genomic similarities between this two coronaviruses. In this study we will test whether inhaled NO therapy prevents progression in patients with mild to moderate COVID-19 disease.

NCT04305457 Coronavirus Infections Pneumonia, Viral Acute Respiratory Distress Syndrome Drug: Nitric Oxide

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: The primary outcome will be the reduction in the incidence of patients requiring intubation and mechanical ventilation, as a marker of deterioration from a mild to a severe form of COVID-19. Patients with indication to intubation and mechanical ventilation but concomitant DNI (Do Not Intubate) or not intubated for any other reason external to the clinical judgment of the attending physician will be considered as meeting the criteria for the primary endpoint.

Measure: Reduction in the incidence of patients with mild/moderate COVID-19 requiring intubation and mechanical ventilation

Time: 28 days

Secondary Outcomes

Description: Proportion of deaths from all causes

Measure: Mortality

Time: 28 days

Description: Time from initiation of the study to discharge or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air), alleviation of cough (defined as mild or absent in a patient reported scale of severe >>moderate>>mild>>absent) and resolution of hypoxia (defined as SpO2 ≥ 93% in room air or P/F ≥ 300 mmHg). All these improvements must be sustained for 72 hours.

Measure: Time to clinical recovery

Time: 28 days

Other Outcomes

Description: Proportion of patients with a negative conversion of RT-PCR from an oropharyngeal or oropharyngeal swab.

Measure: Negative conversion of COVID-19 RT-PCR from upper respiratory tract

Time: 7 days

66 Getting it Right: Towards Responsible Social Media Use During a Pandemic

The investigators plan to conduct a cross-sectional survey to examine how social media use during COVID-19 relates to: (1) information management, (2) assessment of the situation, and (3) affect.

NCT04305574 Coronavirus Depression Anxiety Stress Behavioral: Use of social media during COVID-19

MeSH:Coronavirus Infections Depressio Depression

Primary Outcomes

Description: 21-item validated scale assessing symptoms of depression, anxiety, and stress (DASS-21): Min score = 0, Max score = 21; higher score indicates a worse outcome

Measure: Depression, Anxiety and Stress Scale

Time: Single measurement (upon study enrolment)

Other Outcomes

Description: 3 items on fear of the situation, confidence the government can manage the situation, and assessed chance of being infected (each rated using 4-point scales: min = 1, max = 4; higher scores indicate increased confidence / likelihood / fear)

Measure: Assessment of COVID-19 situation

Time: Single measurement (upon study enrolment)

Description: Participants' self-report of their familiarity (yes/no) and belief of specific (yes/no), and whether they shared these on social media (yes/no)

Measure: Familiarity and trust in COVID-related rumours

Time: Single measurement (upon study enrolment)

67 Nitric Oxide Gas Inhalation Therapy for Mechanically Ventilated Patients With Severe Acute Respiratory Syndrome Caused by SARS-CoV2: a Randomized Clinical Trial.

Severe acute respiratory syndrome (SARS-CoV2) due to novel Coronavirus (2019-nCoV) related infection (COVID-19) is characterized by severe ventilation perfusion mismatch leading to refractory hypoxemia. To date, there is no specific treatment available for 2019-nCoV. Nitric oxide is a selective pulmonary vasodilator gas used in as a rescue therapy in refractory hypoxemia due to acute respiratory distress syndrome (ARDS). In-vitro and clinical evidence indicate that inhaled nitric oxide gas (iNO) has also antiviral activity against other strains of coronavirus. The primary aim of this study is to determine whether inhaled NO improves oxygenation in patients with hypoxic SARS-CoV2. This is a multicenter single-blinded randomized controlled trial with 1:1 individual allocation

NCT04306393 SARS (Severe Acute Respiratory Syndrome) Coronavirus Drug: Nitric Oxide Gas

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Syndrome

Primary Outcomes

Description: Difference within groups in terms of PaO2/FiO2 ratio. If a patient dies during the first 48 hours of treatment, the last available blood gas analysis will be used.

Measure: Change of arterial oxygenation at 48 hours from enrollment

Time: 48 hours

Secondary Outcomes

Description: Time to recover gas exchange to a PaO2/FiO2 =/> 300 for at least 24 hours during the first 28 days after enrollment, within each group and comparison between groups. If the patient dies before day 28, the patient will be considered as "never recovered".

Measure: Time to reach normoxemia during the first 28 days after enrollment

Time: 28 days

Description: Daily proportion of patients with a PaO2/FiO2 ratio > 300 for at least 24 hours within each group and comparison between groups. If a patient dies before day 28, the patient will be considered as "never recovered".

Measure: Proportion of SARS-nCoV-2 free patients during the first 28 days after enrollment

Time: 28 days

Description: Proportion of patients surviving at 28 days within each group and comparison between groups.

Measure: Survival at 28 days from enrollment

Time: 28 days

Description: Proportion of patients surviving at 90 days within each group and comparison between groups.

Measure: Survival at 90 days from enrollment

Time: 90 days

Other Outcomes

Description: Expressed as PaO2/FiO2 ratio within each group and comparison between groups.

Measure: Daily oxygenation in the two groups until day 28

Time: 28 days

Description: Proportion of patients needing RRT within each group and comparison between groups.

Measure: Need for new renal replacement therapy during the first 28 days

Time: 28 days

Description: Proportion of patients needing (i.e., ECMO, intra-aortic balloon pump, VADs) within each group and comparison between groups.

Measure: Mechanical support of circulation during the first 28 days

Time: 28 days

Description: Average days without need for vasopressors within each group and comparison between groups.

Measure: Days free of vasopressors during the first 28 days

Time: 28 days

Description: Average days without need for mechanical ventilation within each group and comparison between groups.

Measure: Ventilator-free day at 28 days

Time: 28 days

Description: Time to obtain first negative upper respiratory trait sample in the 2019-nCoV rt-PCR assay. Average within groups and comparison between groups.

Measure: Time to SARS-CoV-2 rt-PCR negative in upper respiratory tract specimen

Time: 28 days

Description: Average days out of ICU within each group and comparison between groups.

Measure: ICU-free days at 28 days

Time: 28 days

Description: Average days of ICU admission within each group and comparison between groups.

Measure: ICU length of stay

Time: 90 days

68 Acute Respiratory Failure and Continuous Positive Airway Pressure Therapy in Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: a Real Life Evaluation

In December 2019 a new kind of virus was identified in China as the responsible of severe acute respiratory syndrome (SARS) and interstitial pneumonia. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quickly spread around the world and in February 2020 became a pandemia in Europe. No pharmacological treatment is actually licensed for the SARS-CoV2 infection and at the current state of art there is a lack of data about the clinical management of the coronavirus 2019 disease (COVID-19). The aim of this observational study is to collect the data and the outcomes of COVID-19 patients admitted in the H. Sacco Respiratory Unit treated according to the Standard Operating Procedures and the Good Clinical Practice.

NCT04307459 Coronavirus Infections Respiratory Failure Ventilator Lung Other: standard operating procedures

MeSH:Infection Coronavirus Infections Severe Acute Respir Severe Acute Respiratory Syndrome Respiratory Insufficiency

Primary Outcomes

Description: Data collection about the real life management of patients affected by SARS-CoV-2 infection with acute respiratory distress syndrome

Measure: Real life data of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection

Time: 1-6 months

Secondary Outcomes

Description: How many patients died during the hospitalization

Measure: in-hospital mortality

Time: 1 month

Description: How many patients died 30 days after the discharge

Measure: 30 days mortality

Time: 1 month

Description: How many patients died 6 months after the discharge

Measure: 6 months mortality

Time: 6 months

Description: How many patients were intubated during the hospitalization

Measure: Intubation rate

Time: 7 days

Description: How many days/hours from admittance to intubation

Measure: Time to Intubation

Time: 7 days

Description: How many days/hours from admittance to the start of non invasive ventilation or CPAP therapy

Measure: Time to ventilation

Time: 7 days

Description: How many days/hours from the start of non invasive ventilation or CPAP therapy to the intubation

Measure: Non invasive to Invasive time

Time: 7 days

Description: How many patients were healed from the infection and discharged

Measure: Recovery rate

Time: 1 month

Description: How many patients underwent re-infection after previous recovery from COVID19

Measure: Recurrence rate

Time: 1 month

Description: Assessment of the risk factors for the infection and the admission to the hospital

Measure: Risk factor for COVID19

Time: retrospective

Description: What serological parameter could be used as predictor of good or negative prognosis.

Measure: Blood tests and outcome

Time: 1 month

Description: Impact of antiviral therapy on the clinical course of the disease

Measure: Antiviral therapy

Time: 1 month

Description: Assessment of bacterial, fungal or other coinfections rate

Measure: Coinfections

Time: 1 month

Description: Impact of radiological findings on the clinical course and the outcome

Measure: Radiological findings

Time: 1 month

Description: Impact of ultrasound findings on the clinical course and the outcome

Measure: Ultrasound findings

Time: 1 month

Description: Assessment of the evidence of myocardial injury in covid19+ patients

Measure: Myocardial injury

Time: 1 month

Description: impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course.

Measure: Medical management

Time: 1 month

69 Randomized Controlled Clinical Trials of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)

In vitro studies revealed that lopinavir/ritonavir and hydroxychloroquine have antiviral activity against Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, there is no clinical studies on the reduction of viral load in patients with COVID-19. This study investigate whether lopinavir/ritonavir or hydroxychloroquine reduces viral load from respiratory specimen in patients with mild COVID-19.

NCT04307693 COVID-19 Drug: Lopinavir/ritonavir Drug: Hydroxychloroquine sulfate

MeSH:Coronavirus Infections

Primary Outcomes

Description: Area under the curve (AUC) of Ct value or viral copies number per mL

Measure: Viral load

Time: hospital day 3, 5, 7, 10, 14, 18

Secondary Outcomes

Description: Viral load change (log10 viral load assessed by reverse transcription-PCR) during hospital day 3, 5, 7, 10, 14, 18)

Measure: Viral load change

Time: hospital day 3, 5, 7, 10, 14, 18

Description: Time to clinical improvement (TTCI) is defined as the time to normalization of fever, respiratory rate, and oxygen saturation, and alleviation of cough within at least 72 hours

Measure: Time to clinical improvement (TTCI)

Time: up to 28 days

Description: Percentage of progression to supplemental oxygen requirement by day 7

Measure: Percentage of progression to supplemental oxygen requirement by day 7

Time: hospital day 7

Description: Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7

Measure: Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7

Time: hospital day 7

Description: Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission

Measure: Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission

Time: up to 28 days

Description: Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7

Measure: Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7

Time: hospital day 7

Description: Safety and tolerability, as assessed by adverse effects

Measure: adverse effects

Time: up to 28 days

Description: Concentration of Lopinavir/ritonavir and hydroxychloroquine

Measure: Concentration of Lopinavir/ritonavir and hydroxychloroquine

Time: 1, 2, 4, 5, 12 hours after taking intervention medicine

70 Post-exposure Prophylaxis or Preemptive Therapy for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial

Study Objective: 1. To test if post-exposure prophylaxis with hydroxychloroquine can prevent symptomatic COVID-19 disease after known exposure to the SARS-CoV-2 coronavirus. 2. To test if early preemptive hydroxychloroquine therapy can prevent disease progression in persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom severity.

NCT04308668 Corona Virus Infection Acute Respiratory Distress Syndrome SARS-CoV Infection Coronavirus Coronavirus Infections Drug: Hydroxychloroquine Other: Placebo

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: Number of participants at 14 days post enrollment with active COVID19 disease.

Measure: Incidence of COVID19 Disease among those who are asymptomatic at baseline

Time: 14 days

Description: Repeated Measure mixed regression model of change in: Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)

Measure: Overall change in disease severity over 14 days among those who are symptomatic at baseline

Time: 14 days

Secondary Outcomes

Description: Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.

Measure: Incidence of Hospitalization

Time: 14 days

Description: Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease.

Measure: Incidence of Death

Time: 90 days

Description: Outcome reported as the number of participants in each arm who have confirmed SARS-CoV-2 infection.

Measure: Incidence of Confirmed SARS-CoV-2 Detection

Time: 14 days

Description: Outcome reported as the number of participants in each arm who self-report symptoms compatible with COVID19 infection.

Measure: Incidence of Symptoms Compatible with COVID19 (possible disease)

Time: 90 days

Description: Outcome reported as the number of participants in each arm who discontinue or withdraw medication use for any reason.

Measure: Incidence of All-Cause Study Medicine Discontinuation or Withdrawal

Time: 14 days

Description: Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)

Measure: Overall symptom severity at 5 and 14 days

Time: 5 and 14 days

Description: Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the percent of participants who fall into each category per arm.

Measure: Ordinal Scale of COVID19 Disease Severity at 14 days among those who are symptomatic at trial entry

Time: 14 days

71 Favipiravir Combined With Tocilizumab in the Treatment of Corona Virus Disease 2019-A Multicenter, Randomized and Controlled Clinical Trial Study

The purpose of this study is to evaluate the efficacy and safety of favipiravir combined with tocilizumab in the treatment of corona virus disease 2019.

NCT04310228 COVID-19 Drug: Favipiravir Combined With Tocilizumab Drug: Favipiravir Drug: Tocilizumab

MeSH:Coronavirus Infections Virus Diseases

Primary Outcomes

Description: Definition of clinical cure: The viral load of the respiratory specimen was negative for two consecutive times (the interval between the two tests was greater than or equal to one day), the lung image improved, and the body temperature returned to normal for more than 3 days, and the clinical manifestation improved.

Measure: Clinical cure rate

Time: 3 months

Secondary Outcomes

Measure: Viral nucleic acid test negative conversion rate and days from positive to negative

Time: 14 days after taking medicine

Measure: Duration of fever

Time: 14 days after taking medicine

Measure: Lung imaging improvement time

Time: 14 days after taking medicine

Measure: Mortality rate because of Corona Virus Disease 2019

Time: 3 months

Measure: Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs

Time: 3 months

Measure: Mean in-hospital time

Time: 3 months

72 Randomized Controlled Trial of Losartan for Patients With COVID-19 Not Requiring Hospitalization

This is a multi-center, double-blinded study of COVID-19 infected patients randomized 1:1 to daily losartan or placebo for 10 days or treatment failure (hospital admission).

NCT04311177 Corona Virus Infection Acute Respiratory Distress Syndrome SARS-CoV Infection Drug: Losartan Other: Placebo

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: Outcome reported as the number of participants per arm admitted to inpatient hospital care due to COVID-19-related disease within 15 days of randomization. Currently, there is a pre-planned pooled analysis with a national trial network under development.

Measure: Hospital Admission

Time: 15 days

Secondary Outcomes

Description: The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. In the 33-item Functional Limitations bank, 33 daily activities are rated in terms of degree of difficulty while engaging in the activity over the past 7 days (0 = no difficulty, 1 = a little difficulty, 2 = some difficulty, 3 = much difficulty). Total scores range from 0 to 99, with higher scores reflecting greater functional limitations.

Measure: Change in PROMIS Dyspnea Functional Limitations

Time: baseline, 10 days

Description: The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. The 33-item Severity bank assesses the severity of difficulty breathing during various specific activities (the same 33 activities assessed in Dyspnea Functional Limitations). Each activity is rated in terms of degree of dyspnea (0 = no shortness of breath, 1 = mildly short of breath, 2 = moderately short of breath, 3 = severely short of breath) while engaging in the activity over the past 7 days. Total scores range from 0 to 99 with higher scores reflecting greater levels of dyspnea during daily activity.

Measure: Change in PROMIS Dyspnea Severity

Time: baseline, 10 days

Description: Participants will report their maximum daily oral temperature to the study team. Outcome is reported as the mean maximum daily body temperature (in degrees Celsius) over 10 days.

Measure: Daily Maximum Temperature

Time: 10 days

Description: Outcome is reported as the mean number of emergency department and clinic presentations combined per participant in each arm.

Measure: Emergency Department/Clinic Presentations

Time: 28 days

Description: Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

Measure: Disease Severity Rating Day 7

Time: 7 days

Measure: Disease Severity Rating Day 15

Time: 15 days

Measure: Disease Severity Rating Day 28

Time: 28 days

Description: Participants will collect oropharyngeal swabs every third day for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.

Measure: Viral Load by Oropharyngeal Swab Day 9

Time: 9 days

Description: Participants will collect oropharyngeal swabs every third day for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.

Measure: Viral Load by Oropharyngeal Swab Day 15

Time: 15 days

Description: Outcome reported as the mean number of days participants in each arm did not require ventilator use.

Measure: Ventilator-Free Days

Time: 28 days

Description: Outcome reported as the mean number of days participants in each arm did not require therapeutic oxygen use.

Measure: Therapeutic Oxygen-Free Days

Time: 28 days

Description: Outcome reported as the percent of participants in each arm who require hospital admission by day 15 following randomization.

Measure: Need for Hospital Admission at 15 Days

Time: 15 days

Description: Outcome reported as the percent of participants in each arm who require oxygen therapy by day 15 following randomization.

Measure: Need for Oxygen Therapy at 15 Days

Time: 15 days

73 Development and Verification of a New Coronavirus Multiplex Nucleic Acid Detection System

Our project intends to independently develop a fully enclosed rapid detection system for a total of 22 pathogens, including SARS-CoV-2, on the basis of the QIAstat-Dx fully automatic multiple PCR detection platform. The reasonably designed experiments are used to verify the performance of the cartridge detection and prove its clinical application value. The 22 pathogens tested in this project includes 4 coronavirus subtypes, A / B flu, parainfluenza virus, respiratory syncytial virus, etc., which is of great significance for the differential diagnosis of similar patients.

NCT04311398 COVID-19 Diagnostic Test: New QIAstat-Dx fully automatic multiple PCR detection platform

MeSH:Coronavirus Infections

Primary Outcomes

Measure: Sensitivity， spectivity turnaround time of the New QIAstat-Dx fully automatic multiple PCR detection platform

Time: 3 months

74 Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure

Novel Corona Virus (SARS-CoV-2) is known to cause Respiratory Failure, which is the hallmark of Acute COVID-19, as defined by the new NIH/FDA classification. Approximately 50% of those who develop Critical COVID-19 die, despite intensive care and mechanical ventilation. Patients with Critical COVID-19 and respiratory failure, currently treated with high flow nasal oxygen, non-invasive ventilation or mechanical ventilation will be treated with Aviptadil, a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP) plus maximal intensive care vs. placebo + maximal intensive care. Patients will be randomized to intravenous Aviptadil will receive escalating doses from 50 -150 pmol/kg/hr over 12 hours.

NCT04311697 Critical COVID-19 With Respiratory Failure Acute Respiratory Distress Syndrome (ARDS) Corona Virus Infection Acute Lung Injury Drug: Aviptadil by intravenous infusion + standard of care Drug: Normal Saline Infusion + standard of care

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Lung Injury

Primary Outcomes

Description: Mortality

Measure: Mortality

Time: 5 Days with followup through 30 days

Description: Index of Respiratory Distress

Measure: PaO2:FiO2 ratio

Time: 5 Days with followup through the end of telemetry monitoring

Secondary Outcomes

Description: TNF alpha levels as measured in hospital laboratory

Measure: TNF alpha

Time: 5 Days

Description: Multi-system organ failure free days

Measure: Multi-system organ failure free days

Time: 5 days with followup through 30 days

75 Randomized Controlled Trial of Losartan for Patients With COVID-19 Requiring Hospitalization

This is a multi-center, double-blinded study of COVID-19 infected patients requiring inpatient hospital admission randomized 1:1 to daily Losartan or placebo for 7 days or hospital discharge.

NCT04312009 Corona Virus Infection Acute Respiratory Distress Syndrome SARS-CoV Infection Drug: Losartan Other: Placebo

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: Outcome calculated from the partial pressure of oxygen or peripheral saturation of oxygen by pulse oximetry divided by the fraction of inspired oxygen (PaO2 or SaO2 : FiO2 ratio). PaO2 is preferentially used if available. A correction is applied for endotracheal intubation and/or positive end-expiratory pressure. Patients discharged prior to day 7 will have a home pulse oximeter send home for measurement of the day 7 value, and will be adjusted for home O2 use, if applicable. Patients who died will be applied a penalty with a P/F ratio of 0.

Measure: Difference in Estimated (PEEP adjusted) P/F Ratio at 7 days

Time: 7 days

Secondary Outcomes

Description: Outcome reported as the mean number of daily hypotensive episodes (MAP < 65 mmHg) prompting intervention (indicated by a fluid bolus >=500 mL) per participant in each arm.

Measure: Daily Hypotensive Episodes

Time: 10 days

Description: Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.

Measure: Hypotension Requiring Vasopressors

Time: 10 days

Description: Outcome reported as the number of participants in each arm who experience acute kidney injury as defined by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines: Increase in serum creatinine by 0.3mg/dL or more within 48 hours OR Increase in serum creatinine to 1.5 times baseline or more within the last 7 days OR Urine output less than 0.5 mL/kg/h for 6 hours.

Measure: Acute Kidney Injury

Time: 10 days

Description: The SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). Total score is calculated by entering patient data into a SOFA calculator, a widely-available software. Total scores range from 0-24, with higher scores indicating greater chance of mortality.

Measure: Sequential Organ Failure Assessment (SOFA) Total Score

Time: 10 days

Description: Oxygen saturation (percent) is measured by pulse oximeter. Fraction of inspired oxygen (FiO2) (unitless) is the volumetric fraction of oxygen to other gases in respiratory support. The F/S ratio is unitless.

Measure: Oxygen Saturation / Fractional Inhaled Oxygen (F/S)

Time: 10 days

Description: Outcome reported as the number of participants who have expired at 28 days post enrollment.

Measure: 28-Day Mortality

Time: 28 days

Description: Outcome reported as the number of participants who have expired at 90 days post enrollment.

Measure: 90-Day Mortality

Time: 90 days

Description: Outcome reported as the number of participants in each arm who require admission to the Intensive Care Unit (ICU).

Measure: ICU Admission

Time: 10 days

Description: Outcome reported as the mean number of days participants in each arm did not require mechanical ventilation during an in-patient hospital admission.

Measure: Number of Ventilator-Free Days

Time: 10 days

Description: Outcome reported as the mean number of days participants in each arm did not require therapeutic oxygen usage during an in-patient hospital admission.

Measure: Number of Therapeutic Oxygen-Free Days

Time: 10 days

Description: Outcome reported as the mean number of days participants in each arm did not require vasopressor usage during an in-patient hospital admission.

Measure: Number of Vasopressor-Free Days

Time: 10 days

Description: Outcome reported as the mean length of stay (in days) in the Intensive Care Unit (ICU) for participants in each arm.

Measure: Length of ICU Stay

Time: 10 days

Description: Outcome reported as the mean length of in-patient hospital stay (in days) for participants in each arm.

Measure: Length of Hospital Stay

Time: 10 days

Description: Outcome reported as the number of participants requiring BiPAP OR high flow nasal cannula OR mechanical ventilation OR extracorporeal membranous oxygenation (ECMO) utilization during in-patient hospital care in each arm.

Measure: Incidence of Respiratory Failure

Time: 10 days

Measure: Change in PROMIS Dyspnea Functional Limitations

Time: 10 days

Description: The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. The 33-item Severity bank assesses the severity of difficulty breathing during various specific activities (the same 33 activities assessed in Dyspnea Functional Limitations). Each activity is rated in terms of degree of dyspnea (0 = no shortness of breath, 1 = mildly short of breath, 2 = moderately short of breath, 3 = severely short of breath) while engaging in the activity over the past 7 days. Total scores range from 0 to 99 with higher scores reflecting greater levels of dyspnea during daily activity.

Measure: Change in PROMIS Dyspnea Severity

Time: 10 days

Measure: Disease Severity Rating

Time: 10 days

Description: Nasopharyngeal swabs will be collected every third day for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.

Measure: Viral Load by Nasopharyngeal Swab Day 9

Time: 9 days

Description: Nasopharyngeal swabs will be collected every third day for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.

Measure: Viral Load by Nasopharyngeal Swab Day 15

Time: 15 days

Description: Blood will be collected every third day for viral load assessment for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.

Measure: Viral Load by Blood Day 9

Time: 9 days

Description: Blood will be collected every third day for viral load assessment for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.

Measure: Viral Load by Blood Day 15

Time: 15 days

76 Sequential Oxygen Therapy Strategy for Patients With COVID-19

All patients with COVID-19 were divided into three groups according to their illness: mild patient who receive conventional oxygen therapy, severe patients who receive nasal high flow oxygen inhalation or non-invasive positive pressure ventilation，all the oxygen therapy will be used as part of the standard of care. Each group will enroll 10 patients, the treatment of all patients will be continuously optimized during observation, and the incidence of respiratory failure, intubation rate, 28 day mortality rate, ICU hospitalization days, etc will be recorded and analyzed so to optimize the treatment time window of sequential oxygen therapy

NCT04312100 Coronavirus Disease-2019 Other: oxygen treatment

MeSH:Coronavirus Infections

Primary Outcomes

Description: Incidence of respiratory failure at day 28 after enrollment

Measure: Incidence of respiratory failure

Time: 28 day

Secondary Outcomes

Description: mortality rate at day 28 after enrollment

Measure: 28 day mortality rate

Time: 28 day

77 Nitric Oxide Gas Inhalation for Prevention of COVID-19 in Healthcare Providers

Thousands of healthcare workers have been infected with SARS-CoV-2 and contracted COVID-19 despite their best efforts to prevent contamination. No proven vaccine is available to protect healthcare workers against SARS-CoV-2. This study will enroll 470 healthcare professionals dedicated to care for patients with proven SARS-CoV-2 infection. Subjects will be randomized either in the observational (control) group or in the inhaled nitric oxide group. All personnel will observe measures on strict precaution in accordance with WHO and the CDC regulations.

NCT04312243 Coronavirus Infections Healthcare Associated Infection Drug: Inhaled nitric oxide gas

MeSH:Infection Communicable Diseases Cross Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Percentage of subjects with COVID-19 diagnosis in the two groups

Measure: COVID-19 diagnosis

Time: 14 days

Secondary Outcomes

Description: Percentage of subjects with a positive test in the two groups

Measure: Positive SARS-CoV-2 rt-PCR test

Time: 14 days

Other Outcomes

Description: Mean/ Median in the two groups

Measure: Total number of quarantine days

Time: 14 days

Description: Percentage in the two groups

Measure: Proportion of healthcare providers requiring quarantine

Time: 14 days

78 Changes in Organ Specific Biomarkers, Virus Expression and Prognosis of Covid-19

Covid-19 is associated with a wide range of symptoms and clinical trajectories, and early identification of patients at risk for developing severe disease is desirable. Several risk markers and comorbidity profiles have been proposed but their relative importance in unselected patients admitted to hospital with Covid-19 remains unclear. This study aims to assess the prognostic value organ specific biomarkers, viral dynamics and immune response markers in patients infected with SARS-CoV2.

NCT04314232 COVID Coronavirus Infection

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Combined outcome measure of either ICU admission or death

Measure: Number of participants with ICU admission or death

Time: From hospital admission (baseline) until the date of either admission to the ICU or death during the index hospitalization (up to 52 weeks)

Secondary Outcomes

Description: ICU admission

Measure: Number of participants with ICU admission

Time: From hospital admission (baseline) until the date of admission to the ICU during the index hospitalization (up to 52 weeks)

Description: Hospital mortality

Measure: Number of participants with death from all causes

Time: From hospital admission (baseline) unitl the date of death during the index hospitalization (up to 52 weeks)

Description: Total time admitted to the ICU

Measure: Total duration of ICU stay

Time: From admission to the ICU until transfer to another ward, discharge from the hospital or death during the index hospitalization (up to 52 weeks)

Measure: Total duration of hospital stay

Time: From hospital admission (baseline) until hospital discharge or death during the index hospitalization (up to 52 weeks)

79 The Observational Study of Cardiac and Pulmonary Ultrasound and Evaluation of Treatment of Severe Patients With Novel Coronavirus Pneumonia

Complete the examination of cardio-pulmonary ultrasound in accordance with the a-ccue process of patients with novel coronavirus bedside. To summarize and analyze the characteristics of cardiopulmonary ultrasound in patients with novel coronavirus pneumonia, and assess the relationship between pulmonary ultrasound imaging score and National Early Warning Score(NEWS) and prognosis. Auto line B is a method which is based on artificial intelligence is used to calculate the lungs ultrasonic B line numbers reviewing the status of patients with lung, and also evaluate patients' lungs using the traditional artificial semi-quantitative method, to evaluate those two kinds of evaluation methods for the evaluation of patients with lung condition effects are consistent or not, and verify consistency of ultrasonic evaluation method and the way of CT evaluation.

NCT04314271 Novel Coronavirus Pneumonia

MeSH:Coronavirus Infections Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: Complete the examination of cardio-pulmonary ultrasound in accordance with the a-ccue process of patients with novel coronavirus bedside. To summarize and analyze the characteristics of cardiopulmonary ultrasound in patients with novel coronavirus pneumonia

Measure: characteristics of cardiopulmonary ultrasound

Time: 30 mins

Secondary Outcomes

Description: assess the relationship between pulmonary ultrasound imaging score and National Early Warning Score(NEWS) and prognosis.

Measure: assess the relationship between pulmonary ultrasound imaging score and National Early Warning Score(NEWS) and prognosis.

Time: 2-3weeks

Other Outcomes

Description: Auto line B is a method which is based on artificial intelligence is used to calculate the lungs ultrasonic B line numbers reviewing the status of patients with lung, and also evaluate patients' lungs using the traditional artificial semi-quantitative method, to evaluate those two kinds of evaluation methods for the evaluation of patients with lung condition effects are consistent or not

Measure: evaluate two kinds of evaluation methods for the evaluation of patients with lung condition effects are consistent or not, and verify consistency of ultrasonic evaluation method and the way of CT evaluation.

Time: 3 hours

80 Adverse Events Related to Treatments Used Against Coronavirus Disease 2019

The outbreak of Covid-19 started several clinical trials and treatment experiments all over the world in the first months of 2020. This study investigates reports of adverse events related to used molecules, including but not limited to protease inhibitors (lopinavir/ritonavir), chloroquine, azithromycin, remdesivir and interferon beta-1a. Analyses of reports also include the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

NCT04314817 Coronavirus Iatrogenic Disease Acute Kidney Injury ARDS, Human Drug: Any drug used to treat Covid-19

MeSH:Coronavirus Infections Respiratory Distress Syndrome, Adult Acute Kidney Injury Iatrogenic Disease

HPO:Acute kidney injury

Primary Outcomes

Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms

Measure: Renal failure

Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020

Secondary Outcomes

Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms

Measure: Heart failure

Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020

Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms

Measure: EKG disturbance

Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020

Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms

Measure: Hepatic failure

Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020

Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms

Measure: Anemia

Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020

Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms

Measure: Leucopenia

Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020

Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms

Measure: Vascular disease

Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020

Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms

Measure: Toxidermia

Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020

Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms

Measure: Osteoarticular adverse event

Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020

Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms

Measure: Death

Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020

Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms

Measure: Acute respiratory distress syndrome

Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020

Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms

Measure: Pulmonary embolism or pulmonary hypertension

Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020

81 Clinical Characteristics of Coronavirus Disease 2019 (COVID-19) in Pregnancy: The Italian Registry on Coronavirus in Pregnancy

The Novel Coronavirus (2019-nCoV), also known as Wuhan coronavirus, causes the 2019-nCoV acute respiratory disease. The number of patients infected by 2019-nCoV in Italy closely followed an exponential trend, and Italy reported the highest number of infected patients and deaths in the world excluding China.

NCT04315870 Infection Viral Other: pregnant women with laboratory-confirmed 2019-n-CoV

MeSH:Coronavirus Infections Virus Diseases

Primary Outcomes

Description: different maternal and perinatal outcomes were evaluated including: admission to ICU, use of mechanical ventilation, maternal death, early pregnany loss, perinatal death, intrauterine growth restriction (IUGR), preterm birth, mode of delivery, LBW, admission to neonatal ICU (NICU), and clinical or serologic evidence of vertical trasmission

Measure: Maternal and perinatal outcomes

Time: during gestation and at the time of delivery of the baby

82 Hydroxychloroquine Treatment for Severe COVID-19 Respiratory Disease: Randomised Clinical Trial (HYDRA Trial)

Double blinded randomized clinical trial designed to evaluate the security and efficacy of hydroxychloroquine as treatment for COVID-19 severe respiratory disease. The investigators hypothesize that a 400mg per day dose of hydroxychloroquine for 10 days will reduce all-cause hospital mortality in patients with severe respiratory COVID-19 disease.

NCT04315896 COVID-19 Severe Acute Respiratory Syndrome Drug: Hydroxychloroquine Drug: Placebo oral tablet

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: incidence of all-cause mortality

Measure: All-cause hospital mortality

Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days

Secondary Outcomes

Description: Days from ER admission to hospital discharge

Measure: Length of hospital stay

Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days

Description: need of invasive or non invasive mechanical ventilation

Measure: Need of mechanical ventilation

Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days

Description: 28 minus days without invasive ventilation support in patients with invasive mechanical ventilation at randomization

Measure: Ventilator free days

Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days

Description: Adverse Reactions

Measure: Grade 3-4 adverse reaction

Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days

83 Multi-centre, Adaptive, Randomized Trial of the Safety and Efficacy of Treatments of COVID-19 in Hospitalized Adults

This study is a multi-centre, adaptive, randomized, open clinical trial of the safety and efficacy of treatments for COVID-19 in hospitalized adults. The study is a multi-centre/country trial that will be conducted in various sites in Europe with Inserm as sponsor. Adults (≥18 year-old) hospitalized for COVID-19 with SpO2 ≤ 94% on room air OR acute respiratory failure requiring supplemental oxygen or ventilatory support will be randomized between 4 treatment arms, each to be given in addition to the usual standard of care (SoC) in the participating hospital: SoC alone versus SoC + Remdesivir versus SoC + Lopinavir/Ritonavir versus SoC (this treatment arm has been ceased since June 29, 2020) + Lopinavir/Ritonavir plus interferon ß-1a versus SoC (this treatment arm has been ceased since June 29, 2020) + Hydroxychloroquine (this treatment arm has been ceased since May 24, 2020). Randomization will be stratified by European region and severity of illness at enrollment (moderate disease: patients NOT requiring non-invasive ventilation NOR high flow oxygen devices NOR invasive mechanical ventilation NOR ECMO and severe disease: patients requiring non-invasive ventilation OR high flow oxygen devices OR invasive mechanical ventilation OR ECMO). The interim trial results will be monitored by a Data Monitoring Committee, and if at any stage evidence emerges that any one treatment arm is definitely inferior then it will be centrally decided that that arm will be discontinued. Conversely, if good evidence emerges while the trial is continuing that some other treatment(s) should also be being evaluated then it will be centrally decided that one or more extra arms will be added while the trial is in progress. The primary objective of the study is to evaluate the clinical efficacy and safety of different investigational therapeutics relative to the control arm in patients hospitalized with COVID-19, the primary endpoint is the subject clinical status (on a 7-point ordinal scale) at day 15.

NCT04315948 Corona Virus Infection Drug: Remdesivir Drug: Lopinavir/ritonavir Drug: Interferon Beta-1A Drug: Hydroxychloroquine Other: Standard of care

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.

Measure: Percentage of subjects reporting each severity rating on a 7-point ordinal scale

Time: Day 15

Secondary Outcomes

Description: Time to an improvement of one category from admission on an ordinal scale. Time to an improvement of two categories from admission on an ordinal scale. Time to discharge (categories 1 or 2 of ordinal scale) from admission. Subject clinical status on an ordinal scale at days 3, 5, 8, 11, and 29. Mean change in the ranking on an ordinal scale from baseline to days 3, 5, 8, 11, 15 and 29 from baseline.

Measure: Percentage of subjects reporting each severity rating on a 7-point on an ordinal scale

Time: Days 3, 5, 8, 11, 15 and 29

Description: • Change from baseline to days 3, 5, 8, 11, 15, and 29 in NEWS.

Measure: The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first.

Time: Days 3, 5, 8, 11, 15 and 29

Measure: Number of oxygenation free days in the first 28 days

Time: 29 days

Measure: Incidence of new oxygen use, non-invasive ventilation or high flow oxygen devices during the trial.

Time: 29 days

Measure: Duration of new oxygen use, non-invasive ventilation or high flow oxygen devices during the trial.

Time: 29 days

Measure: Ventilator free days in the first 28 days

Time: 29 days

Measure: Incidence of new mechanical ventilation use during the trial.

Time: 29 days

Description: • Duration of hospitalization (days).

Measure: Hospitalization

Time: 29 days

Description: Rate of mortality

Measure: Mortality

Time: In hospital, Day 28, Day 90

Measure: Cumulative incidence of serious adverse events (SAEs)

Time: 29 days

Measure: Cumulative incidence of Grade 3 and 4 adverse events (AEs)

Time: 29 days

Measure: Number of participants with a discontinuation or temporary suspension of study drugs (for any reason)

Time: 29 days

Measure: Changes from baseline in blood white cell count

Time: 29 days

Measure: Changes from baseline in haemoglobin

Time: 29 days

Measure: Changes from baseline in platelets

Time: 29 days

Measure: Changes from baseline in creatinine

Time: 29 days

Measure: Changes from baseline in blood electrolytes (including kaliemia)

Time: 29 days

Measure: Changes from baseline in prothrombine time

Time: 29 days

Measure: Changes from baseline in international normalized ratio (INR)

Time: 29 days

Measure: Changes from baseline in glucose

Time: 29 days

Measure: Changes from baseline in total bilirubin

Time: 29 days

Measure: Changes from baseline in alanine aminotransferase (ALT)

Time: 29 days

Measure: Changes from baseline in aspartate aminotransferase (AST)

Time: 29 days

Other Outcomes

Measure: Percent of subjects with SARS-CoV-2 detectable in nasopharyngeal sample

Time: Days 3, 5, 8, 11, 15, 29

Measure: Quantitative SARS-CoV-2 virus in nasopharyngeal sample

Time: Days 3, 5, 8, 11, 15, 29

Measure: Quantitative SARS-CoV-2 virus in blood

Time: Days 3, 5, 8 and 11

Description: On Day 1, plasma concentration 4 hours after the first administration (peak), and before the second administration (trough at H12) On Days 3, 5, 8 and 11, trough plasma concentration (before dose administration) while hospitalized

Measure: Plasma concentration of lopinavir

Time: Days 1, 3, 5, 8 and 11

Measure: Plasma concentration of hydroxychloroquine

Time: Days 1, 3, 5, 8 and 11

84 Norwegian Coronavirus Disease 2019 Study: An Open Labeled Randomized Controlled Pragmatic Trial to Evaluate the Antiviral Effect of Chloroquine in Adult Patients With SARS-CoV-2 Infection

In the current proposal, the investigators aim to investigate the virological and clinical effects of chloroquine treatment in patients with established COVID-19 in need of hospital admission. Patients will be randomized in a 1:1 fashion to standard of care or standard of care with the addition of therapy with chloroquine.

NCT04316377 Corona Virus Infection Drug: Hydroxychloroquine Sulfate

MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Virus Diseases

Primary Outcomes

Description: Viral load assessed by real time polymerase chain reaction in oropharyngeal samples

Measure: Rate of decline in SARS-CoV-2 viral load

Time: Baseline (at randomization) and at 96 hours

Secondary Outcomes

Description: National Early Warning Score score determines the degree of illness of a patient. Scores range from 0-20, with a higher score representing further removal from normal physiology and a higher risk of morbidity and mortality.

Measure: Change in National Early Warning Score score

Time: Baseline (at randomization) and at 96 hours

Description: Transfer from regular ward to intensive care unit during index admission

Measure: Admission to intensive care unit

Time: At all times after randomization during index admission (between admission and discharge, approximately 21 days)

Description: All-cause mortality during index admission

Measure: In-hospital mortality

Time: At all times after randomization during index admission (between admission and discharge, approximately 21 days)

Description: Total days admitted to the hospital (difference between admission date and discharge date of index admission)

Measure: Duration of hospital admission

Time: During index admission (between admission and discharge, approximately 21 days)

Description: All-cause mortality assessed at 30 and 90 days

Measure: Mortality at 30 and 90 days

Time: At follow-up 30 and 90 days

Description: Percentage of subjects reporting each severity rating on a 7-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized, but unable to resume normal activities Not hospitalized, with resumption of normal activities

Measure: Clinical status

Time: 14 days after randomization

Description: Change in C-reactive protein concentrations from randomization to 96 hours after randomization

Measure: Change in C-reactive protein concentrations

Time: Baseline (at randomization) and at 96 hours

Description: Change in alanine aminotransferase concentrations from randomization to 96 hours after randomization

Measure: Change in alanine aminotransferase concentrations

Time: Baseline (at randomization) and at 96 hours

Description: Change in aspartate aminotransferase concentrations from randomization to 96 hours after randomization

Measure: Change in aspartate aminotransferase concentrations

Time: Baseline (at randomization) and at 96 hours

Description: Change in bilirubin concentrations from randomization to 96 hours after randomization

Measure: Change in bilirubin concentrations

Time: Baseline (at randomization) and at 96 hours

Description: Change in estimated glomerular filtration rate from randomization to 96 hours after randomization

Measure: Change in estimated glomerular filtration rate

Time: Baseline (at randomization) and at 96 hours

Description: Change in cardiac troponin concentrations from randomization to 96 hours after randomization

Measure: Change in cardiac troponin concentrations

Time: Baseline (at randomization) and at 96 hours

Description: Change in natriuretic peptide concentrations from randomization to 96 hours after randomization

Measure: Change in natriuretic peptide concentrations

Time: Baseline (at randomization) and at 96 hours

85 Clinical Performance of the VivaDiag ™ COVID-19 lgM / IgG Rapid Test in a Cohort of Negative Patients for Coronavirus Infection for the Early Detection of Positive Antibodies for COVID-19

This study aim to evaluate the immune response of negative patients during a COVID-19 outbreak. Patients are serially tested with a VivaDiag ™ COVID-19 lgM / IgG Rapid Test to evaluate the immune response in negative patients and the reliability of the test in those patients who develop clinical signs of COVID-19 during the trial.

NCT04316728 Coronavirus Infections Device: VivaDiag™ COVID-19 lgM/IgG Rapid Test

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of patients with negative results in the three measurements, compared to the number of patients with at least one positive test

Measure: Number of patients with constant negative results

Time: 30 days

Description: Number of patients that present at least one positive VivaDiag test that when subsequently tested with PCR remain positive

Measure: Number of patients with positive test with a positive PCR for COVID-19

Time: 30 days

Description: Where available, number of patients positive for COVID-19 IgG and IgM and positive for COVID-19 PCR

Measure: Overall Number of patients positive for COVID-19

Time: six months

Description: Where available, number of patients negative for COVID-19 IgG and IgM and negative for COVID-19 PCR

Measure: Overall Number of patients negative for COVID-19

Time: six months

Description: Where available, number of patients positive for COVID-19 IgG and IgM and negative for COVID-19 PCR, or negative for COVID-19 IgG and IgM and positive for COVID-19 PCR

Measure: Number of patients with contrasting results

Time: 30 days

Secondary Outcomes

Description: Number of Invalid results

Measure: Reliability of the test

Time: 30 days

Description: Number of healthcare workers that become positive for COVID-19 IgM or IgG

Measure: Positive HCW

Time: 60 days

Description: Number of Chronic Patients that become positive for COVID-19 IgM or IgG

Measure: Number of Chronic Patients

Time: 60 days

86 A Randomized, Double-blind, Placebo-controlled, Multi-site, Phase III Study to Evaluate the Safety and Efficacy of CD24Fc in COVID-19 Treatment

The study is designed as a randomized, placebo-controlled, double blind, multicenter, Phase III trial to compare two COVID-19 treatment regimens in hospitalized adult subjects who are diagnosed with severe COVID 19. Arm A: CD24Fc/Best Available Treatment; Arm B: placebo/ Best Available Treatment. CD24Fc will be administered as single dose of 480 mg via IV infusion on Day 1. Total of 230 subjects will be enrolled and randomized in 1:1 ratio to receive CD24Fc or placebo. All subjects will be treated with the best available treatment. The follow up period is 28 days.

NCT04317040 Severe Coronavirus Disease (COVID-19) Drug: CD24Fc Drug: Placebo

MeSH:Coronavirus Infections

Primary Outcomes

Description: Time to improve in clinical status: the time (days) required from the start of treatment to the improvement of clinical status "severe" to "moderate/mild"; or improvement from "scale 3 or 4" to "scale 5 or higher" based on NIAID ordinal scales.

Measure: Improvement of COVID-19 disease status

Time: 29 days

Secondary Outcomes

Description: Proportion of patients who died or had respiratory failure, defined as the need for mechanical ventilation, ECMO, non-invasive ventilation, or high flow oxygen devices, at Day 29

Measure: Proportion of patients who died or had respiratory failure.

Time: 29 days

Description: Time for disease progression from NIAID scale 3 or 4 to need to be on invasive mechanical ventilation, or ESMO, or death.

Measure: Disease progression of COVID-19

Time: 29 days

Description: All cause of death

Measure: All cause of death

Time: 29 days

Description: Proportion of clinical relapse, as defined by rate of return to oxygen support for more than 1 day within 29 days from randomization after initial recovery

Measure: Proportion of clinical relapse

Time: 29 days

Description: Conversion rate of clinical status on days 8 (proportion of subjects who changed from NIAID ordinal "scale 3 or 4" to "scale 5 or higher")

Measure: Conversion rate of clinical status at Day 8

Time: 8 days

Description: Conversion rate of clinical status on days 15 (proportion of subjects who changed from NIAID ordinal "scale 3 or 4" to "scale 5 or higher")

Measure: Conversion rate of clinical status at Day 15

Time: 15 days

Description: The discharge time, calculated after the randomization.

Measure: Hospital discharge time

Time: 29 days

Description: Duration of mechanical ventilation (IMV, NIV) (days)

Measure: Duration of mechanical ventilation

Time: 29 days

Description: Duration of pressors (days)

Measure: Duration of pressors

Time: 29 days

Description: Duration of extracorporeal membrane oxygenation (days)

Measure: Duration of ECMO

Time: 29 days

Description: Duration of oxygen therapy (oxygen inhalation by high flow nasal cannula or mask) (days)

Measure: Duration of high flow oxygen therapy

Time: 29 days

Description: Changes of absolute lymphocyte count in peripheral blood

Measure: Absolute lymphocyte count

Time: 29 days

Description: The changes of plasma concentration of D-dimers

Measure: Change of D-dimers

Time: 15 and 29 days

87 Chemoprophylaxis With Hydroxychloroquine in Healthcare Personnel in Contact With COVID-19 Patients: A Randomized Controlled Trial (PHYDRA Trial)

Triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) aiming to prove hydroxychloroquine's security and efficacy as prophylaxis treatment for healthcare personnel exposed to COVID-19 patients.

NCT04318015 COVID-19 Severe Acute Respiratory Syndrome Drug: Hydroxychloroquine Drug: Placebo oral tablet

MeSH:Severe Acute Respiratory Syndrome Corona Coronavirus Infections

Primary Outcomes

Description: Symptomatic infection rate by COVID-19 defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive COVID-19 real-time polymerase chain reaction test.

Measure: Symptomatic COVID-19 infection rate

Time: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start

Secondary Outcomes

Description: Symptomatic infection rate by other non-COVID-19 viral etiologies defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive viral real time polymerase chain reaction test.

Measure: Symptomatic non-COVID viral infection rate

Time: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start

Description: Number of days absent from labor due to COVID-19 symptomatic infection

Measure: Days of labor absenteeism

Time: From date of randomization until study completion 60 days after treatment start

Description: Absenteeism from labor rate due to COVID-19 symptomatic infection

Measure: Rate of labor absenteeism

Time: From date of randomization until study completion 60 days after treatment start

Description: Rate of severe respiratory COVID-19 disease in healthcare personnel

Measure: Rate of severe respiratory COVID-19 disease in healthcare personnel

Time: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start

88 COVID-19: Healthcare Worker Bioresource: Immune Protection and Pathogenesis in SARS-CoV-2

Modelling repurposed from pandemic influenza is currently informing all strategies for SARS-CoV-2 and the disease COVID-19. A customized disease specific understanding will be important to understand subsequent disease waves, vaccine development and therapeutics. For this reason, ISARIC (the International Severe Acute Respiratory and Emerging Infection Consortium) was set up in advance. This focuses on hospitalised and convalescent serum samples to understand severe illness and associated immune response. However, many subjects are seroconverting with mild or even subclinical disease. Information is needed about subclinical infection, the significance of baseline immune status and the earliest immune changes that may occur in mild disease to compare with those of SARS-CoV-2. There is also a need to understand the vulnerability and response to COVID-19 of the NHS workforce of healthcare workers (HCWs). HCW present a cohort with likely higher exposure and seroconversion rates than the general population, but who can be followed up with potential for serial testing enabling an insight into early disease and markers of risk for disease severity. We have set up "COVID-19: Healthcare worker Bioresource: Immune Protection and Pathogenesis in SARS-CoV-2". This urgent fieldwork aims to secure significant (n=400) sampling of healthcare workers (demographics, swabs, blood sampling) at baseline, and weekly whilst they are well and attending work, with acute sampling (if hospitalised, via ISARIC, if their admission hospital is part of the ISARIC network) and convalescent samples post illness. These will be used to address specific questions around the impact of baseline immune function, the earliest immune responses to infection, and the biology of those who get non-hospitalized disease for local research and as a national resource. The proposal links directly with other ongoing ISARIC and community COVID projects sampling in children and the older age population. Reasonable estimates suggest the usable window for baseline sampling of NHS HCW is closing fast (e.g. baseline sampling within 3 weeks).

NCT04318314 Health Care Worker Patient Transmission Coronavirus Coronavirus Infections Immunological Abnormality Diagnostic Test: COPAN swabbing and blood sample collection

MeSH:Coronavirus Infections Severe Acute Respiratory Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Home-isolation or hospital admission

Measure: Seroconversion to SARS-CoV-2 positivity

Time: Within 6 months

89 Study to Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response

Collection and analysis of demographic, clinical, radiographic and laboratory characteristics of CoViD-19 patients to identify predictors of disease severity, mortality and treatment response, and to identify subgroup of patients that might benefit from specific therapeutic interventions

NCT04318366 Coronavirus Infections Other: Observational Study

MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response

Measure: Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response

Time: Hospital stay (2-3 weeks)

90 Hydroxychloroquine Post Exposure Prophylaxis (PEP) for Household Contacts of COVID-19 Patients: A NYC Community-Based Randomized Clinical Trial

The purpose of this study is to test the hypothesis that post-exposure prophylaxis with hydroxychloroquine will reduce the symptomatic secondary attack rate among household contacts of known or suspected COVID-19 patients.

NCT04318444 COVID-19 Corona Virus Infection Drug: Hydroxychloroquine Drug: Placebo oral tablet

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: This is defined as either 1. COVID-19 infection confirmed within 14 days of enrollment, following self-report of COVID-19 symptoms to the research study; OR, 2. COVID-19 infection confirmed within 14 days of enrollment, with self-report of COVID-19 symptoms to a treating physician.

Measure: Number of participants with symptomatic, lab-confirmed COVID-19.

Time: Date of enrollment to 14 days post-enrollment date

91 Multicentric Study of Coronavirus Disease 2019 (COVID-2019) in Solid Organ Transplant Recipients

The overall purpose of this project is to better understand the incidence, risk factors, etiology, clinical manifestations and outcome of tCOVID19 in solid organ transplant recipients. The results obtained will allow us to gain insight on the need of antiviral treatment, on the strategy for complications surveillance, on how to adjust the immunosuppressant therapy and on the level of care in which each patient should be treated. In order to attain the objectives previously described we will develop a multicenter prospective study of consecutive cases of COVID-19 among solid organ transplant recipients.

NCT04319172 Transplant Recipient Infections, Coronavirus

MeSH:Coronavirus Infections

Primary Outcomes

Description: Number of Solid Organ Transplant Recipients positive to coronavirus

Measure: Incidence of coronavirus infection in Solid Organ Transplant Recipients

Time: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus

Description: Number of participants who present clinical symptoms possibly related to coronavirus infection in Solid Organ Transplant Recipients

Measure: Clinical manifestations of coronavirus infection in Solid Organ Transplant Recipients

Time: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus

Description: Gathering possible risk factors in coronavirus infection in Solid Organ Transplant

Measure: Presence of other risk factors

Time: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus

Description: Establish the frequency and type of complications related to the net state of the patient immunosuppression

Measure: Establish the frequency and type of complications related to the net state of the patient immunosuppression

Time: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus

Secondary Outcomes

Description: Another infections at the time of coronavirus positive infection will be gathered

Measure: Frequency of co-infections

Time: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus

Description: Number of deaths caused or complicated by coronavirus infection in patients who has recceived Solid Organ Transplant

Measure: Mortality

Time: From baseline at the time of signature of informed consent form up to study completion at 3 months folllow-up

Description: Biochemical analysis, hemogram,

Measure: Laboratory characteristics

Time: At inclusion and at 28 days of follow up

Description: Nasopharyngeal swabs

Measure: Determination of coronavirus viral load

Time: At inclusion at 14 days and at 28 days

Description: According to the clinical manifestations at blood culture, pleural liquid culture, gram stain and culture of sputum, detection of pneumococcus and Legionella pneumophila antigen in urine, in cases of pneumonia

Measure: Microbiological testing

Time: At inclusion at 14 days and at 28 days

92 Investigation of Physical Activity, Quality of Life and Stress Levels of Individuals Who Live in Their Homes Isolated Because of Coronavirus (COVID-19) Disease

The aim of our study is to investigate the physical activity, quality of life and stress levels of individuals living in their homes isolated due to coronavirus (COVID-19) disease. The last three sections of the International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants. Parameters such as housework, home care and family care, rest, sports and leisure physical activities, sitting time will be evaluated. Short Form 12 (Short Form12- SF12) quality of life scale will be used to evaluate health-related quality of life. Beck Depression Scale will be applied to investigate the stress levels of the individuals participating in our study.

NCT04319211 Healthy People Other: Determination of physical activity, quality of life, stress levels of isolated people at home with the danger of coronavirus.

MeSH:Coronavirus Infections

Primary Outcomes

Description: The International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants. The survey validity and reliability studies have been conducted in Turkey by Ozturk. The survey consists of 27 questions and 5 parts.

Measure: International Physical Activity Questionnaire (IPAQ)

Time: 4 weeks

Description: Short Form 12 (Short Form12- SF12) quality of life scale will be used to evaluate health-related quality of life. SF-12 is an easy-to-apply 12-question scale that has been validated and reliable and obtained by shortening and simplifying SF-36, which evaluates the last 4 weeks.

Measure: Health-Related Quality of Life SF-12 Scale

Time: 4 weeks

Description: The individuals participating in our study will be evaluated with the Beck Depression Scale developed in 1961 by Beck et al. The scale validity and reliability studies have been conducted in Turkey by Hisli. The scale is a likert-type scale consisting of 21 items, each scored between 0-3.

Measure: Beck Depression Scale

Time: 4 weeks

93 Clinical Trial of Favipiravir Tablets Combine With Chloroquine Phosphate in the Treatment of Novel Coronavirus Pneumonia

This study is a multi-centered, three-armed, randomized, double-blinded, controlled study, namely, the oral trial drug favipiravir tablets plus chloroquine phosphatetablets tablets group (combined group), the oral trial drug favipiravir tablets group (pirovir group), and the oral placebo treatment group (control group). The total number of enrolled cases in this study was set at 150. During the treatment, the clinical data of the subjects were collected, the changes of viral load and biochemical indicators were detected, and the outcome of the subjects was monitored. The main indicators of efficacy include improvement or recovery of respiratory symptoms and viral nucleic acid shedding. The rate of progression to severe disease, duration of fever, peripheral blood index and improvement time of pulmonary imaging were the secondary indicators to evaluate the efficacy. Statistical analysis was performed at the middle and final stages of the study to evaluate the efficacy and safety of favipiravir tablets combined with chloroquine phosphatetablets tablets in the treatment of novel coronavirus pneumonia.

NCT04319900 Novel Coronavirus Pnuemonia Drug: favipiravir tablets+chloroquine phosphatetablets tablets Drug: Favipiravir tablets Drug: Placebo

MeSH:Coronavirus Infections Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: Time of improvement or recovery of respiratory symptoms

Measure: Time of Improvement or recovery of respiratory symptoms

Time: 10 days during the intervention period

Description: Number of days from positive to negative for test of swab or sputum virus nucleic acid

Measure: Number of days virus nucleic acid shedding

Time: 10 days during the intervention period

Description: Frequency of improvement or recovery of respiratory symptoms

Measure: Frequency of Improvement or recovery of respiratory symptoms

Time: 10 days during the intervention period

Secondary Outcomes

Description: Duration of fever after recruitment

Measure: Duration of fever

Time: 10 days during the intervention period

Description: Disease is defined as severe if it meets any of the following criteria: 1.Respiratory rate ≥30/min; 2. Oxygen saturation ≤93%; 3. Arterial partial oxygen pressure (PaO2)/oxygen absorption concentration (FiO2) ≤300 mmHg (1 mmHg=0.133 kPa)

Measure: Frequencies of progression to severe illness

Time: 10 days during the intervention period

Description: Time of improvement of pulmonary imaging

Measure: Time of improvement of pulmonary imaging

Time: 10 days during the intervention period

Description: Peripheral blood c-reactive protein concentration

Measure: Peripheral blood c-reactive protein concentration

Time: day-1,3,7,14 after the intervention period

Description: Absolute value of peripheral blood lymphocytes

Measure: Absolute value of peripheral blood lymphocytes

Time: day-1,3,7,14 after the intervention period

Description: percentage of peripheral blood lymphocytes

Measure: percentage of peripheral blood lymphocytes

Time: day-1,3,7,14 after the intervention period

94 An Clinic Trial of Recombinant Human Interferon Alpha Nasal Drops to Prevent Coronavirus Disease 2019 in Medical Staff in Epidemic Area

The investigators plan to carry out an experimental study on the preventive effect of recombinant human interferon alpha nasal drops on the infection of 2019 new coronavirus in medical staff.

NCT04320238 2019 Novel Coronavirus Infection Drug: recombinant human interferon Alpha-1b Drug: thymosin alpha 1

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: new-onset coronavirus disease-2019

Measure: new-onset COVID-19

Time: From date of randomization until the diagnosis of COVID-19, assessed up to 6 weeks.

Secondary Outcomes

Description: new-onset fever or respiratory symptoms but with negative pulmonary images evidence.

Measure: Number of Participants with coronavirus related symptoms

Time: during 28-day intervention.

Description: adverse effect of interferon α

Measure: Number of Participants with adverse effect

Time: during 28-day intervention.

95 COVID CT, Beaumont Quantitative Lung Function Imaging to Characterize Patients With SARS-COV 2

The goal of this study is to evaluate if CT (Computerized Tomography) can effectively and accurately predict disease progression in patients with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). You may be eligible if you have been diagnosed with SARS-CoV-2, are an inpatient at Beaumont Hospital-Royal Oak and meet eligibility criteria. After consent and determination of eligibility, enrolled patients will have a CT scanning session. After the CT scan, patients are followed for 30 days by reviewing their medical records and by phone after discharge from hospital.

NCT04320511 SARS-COV2 Severe Acute Respiratory Syndrome COVID-19 Device: CT-V

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: Disease progression will be characterized as requiring mechanical ventilator support, non-invasive positive pressure ventilation, high flow nasal cannula or mortality within 30 days.CT-V and PBM scores will be calculated at a voxel level from inhalation-exhalation CT scan. Several CT-V pulmonary function metrics, including the volume of identified "cold spots" (areas with decreased ventilation and perfusion), total ventilation and perfusion and radiographic fibrosis score will be calculated to assess regional ventilation/perfusion and compared to disease progression. The number of participants with correlation between these factors will be reported.

Measure: Predictive association between CT-V, PBM score and disease progression

Time: 30 days

96 Risk Factors for Community- and Workplace Transmission of COVID-19

The project is an epidemiological observational study based on an electronic questionnaire on risk factors for COVID-19 in the community and healthcare setting.

NCT04320732 Coronavirus Behavioral: Observation of behavior and COVID-19 infection will be conducted.

MeSH:Coronavirus Infections

Primary Outcomes

Description: Diagnosed with serology or direct viral detection

Measure: Rate of COVID-19 infection

Time: 1 year

97 The Impact of Camostat Mesilate on COVID-19 Infection: An Investigator-initiated Randomized, Placebo-controlled, Phase IIa Trial

SARS-CoV-2, one of a family of human coronaviruses, was initially identified in December 2019 in Wuhan city. This new coronavirus causes a disease presentation which has now been named COVID-19. The virus has subsequently spread throughout the world and was declared a pandemic by the World Health Organisation on 11th March 2020. As of 18 March 2020, there are 198,193 number of confirmed cases with an estimated case-fatality of 3%. There is no approved therapy for COVID-19 and the current standard of care is supportive treatment. SARS-CoV-2 exploits the cell entry receptor protein angiotensin converting enzyme II (ACE-2) to access and infect human cells. The interaction between ACE2 and the spike protein is not in the active site. This process requires the serine protease TMPRSS2. Camostat Mesilate is a potent serine protease inhibitor. Utilizing research on severe acute respiratory syndrome coronavirus (SARS-CoV) and the closely related SARS-CoV-2 cell entry mechanism, it has been demonstrated that SARS-CoV-2 cellular entry can be blocked by camostat mesilate. In mice, camostat mesilate dosed at concentrations similar to the clinically achievable concentration in humans reduced mortality following SARS-CoV infection from 100% to 30-35%.

NCT04321096 Corona Virus Infection Drug: Camostat Mesilate Drug: Placebo oral tablet

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Clinical improvement defined as live hospital discharge OR a 2 point improvement (from time of enrolment) in disease severity rating on the 7-point ordinal scale

Measure: Cohort 1: Days to clinical improvement from study enrolment

Time: 30 days

Description: Days to clinical improvement from study enrolment defined no fever for at least 48 hrs AND improvement in other symptoms (e.g. cough, expectoration, myalgia, fatigue, or head ache)

Measure: Cohort 2: Days to clinical improvement from study enrolment

Time: 30 days

Secondary Outcomes

Measure: Safety evaluation, as measured by AEs, Adverse Reactions (ARs), SAEs, Serious ARs (SARs)

Time: 30 days

Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

Measure: Cohort 1: Clinical status as assessed by the 7-point ordinal scale at day 7, 14 and 30

Time: 30 days

Description: Mortality

Measure: Cohort 1: Day 30 mortality

Time: 30 days

Description: NEWS2

Measure: Cohort 1: Change in NEW(2) score from baseline to day 30

Time: 30 days

Description: ICU

Measure: Cohort 1: Admission to ICU

Time: 30 days

Description: invasive mechanical ventilation or ECMO

Measure: Cohort 1: Use of invasive mechanical ventilation or ECMO

Time: 30 days

Description: Nasal or high-flow oxygen

Measure: Cohort 1: Duration of supplemental oxygen (days)

Time: 30 days

Description: Subjective clinical improvement

Measure: Cohort 1+2: Days to self-reported recovery (e.g. limitations in daily life activities) during telephone interviews conducted at day 30

Time: 30 days

Description: No of new COVID-19 infections in the household

Measure: Cohort 2: Number participant-reported secondary infection of housemates

Time: 30 days

Description: Hospital admission

Measure: Cohort 2: Time to hospital admission related to COVID-19 infection

Time: 30 days

98 COVID-19 Ring-based Prevention Trial With Lopinavir/Ritonavir

COVID-19 has rapidly evolved into a generalized global pandemic. Post-exposure prophylaxis (PEP) against on COVID-19 was identified as an urgent research priority by the WHO, and lopinavir/ritonavir (LPV/r) is a promising candidate for both COVID-19 treatment and PEP, with a good safety profile and global availability. This is a cluster randomized controlled trial (RCT) of oral LPV/r as PEP against COVID-19, that will address the immediate need for preventive interventions, generate key data on COVID-19 transmission, and serve as a research platform for future vaccines and preventive agents.

NCT04321174 Coronavirus Infections Post-exposure Prophylaxis Drug: Lopinavir/ritonavir

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary outcome is microbiologically confirmed COVID-19 infection, ie. detection of viral RNA in a respiratory specimen (mid-turbinate swab, nasopharyngeal swab, sputum specimen, saliva specimen, oral swab, endotracheal aspirate, bronchoalveolar lavage specimen) by day 14 of the study.

Measure: Microbiologic evidence of infection

Time: 14 days

Secondary Outcomes

Description: a) Adverse events: as defined using the DAIDS Table for Grading the Severity of Adverse Events, at 7, 14, 28 & 90 days

Measure: Adverse events

Time: 90 days

Description: fever, cough or other respiratory/ systemic symptoms (including but not limited to fatigue, myalgias, arthralgias, shortness of breath, sore throat, headache, chills, coryza, nausea, vomiting, diarrhea) by day 14 in a patient with laboratory confirmed infection, combined with microbiologic confirmation of COVID-19 infection in the participant.

Measure: Symptomatic COVID-19 disease

Time: 14 days

Description: Reactive serology to SARS-CoV-2

Measure: Seropositivity

Time: 28 days

Description: The number of days (or partial days) spent admitted to an acute care hospital will be tabulated both at day 28 and day 90

Measure: Days of hospitalization attributable to COVID-19 disease

Time: 90 days

Description: The number of days (or partial days) requiring i) non-invasive and ii) endotracheal intubation with ventilation will be tabulated both at day 28 and day 90.

Measure: Respiratory failure requiring ventilatory support attributable to COVID-19 disease

Time: 90 days

Description: Death attributable to COVID-19 disease and all-cause mortality

Measure: Mortality

Time: 90 days

Description: Short-term psychological distress will be measured using the K10, with a standard cutoff score of ≥16.

Measure: Short-term psychological impact of exposure to COVID-19 disease

Time: 28 days

Description: Long-term impact will be measured at day 90 using the Impact of Event Scale, a validated measure of traumatic stress response, using a standard cutoff score of ≥26

Measure: Long-term psychological impact of exposure to COVID-19 disease

Time: 90 days

Description: Health-related quality of life will be measured using the EQ-5D-5L (EuroQol-5D). The EQ-5D consists of two pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The tool will be administered to participants at 1, 14, 28 and 90 days.

Measure: Health-related quality of life

Time: 90 days

99 Evaluation of the Safety and Clinical Efficacy of Hydroxychloroquine Associated With Azithromycin in Patients With Pneumonia Caused by Infection by the SARS-CoV2 Virus - Coalition COVID-19 Brasil II - SEVERE - Patients

The Severe Acute Respiratory Syndrome COronaVirus 2 (SARS-CoV2) is a new and recognized infectious disease of the respiratory tract. Around 20% of those infected have severe pneumonia and currently there is no specific or effective therapy to treat this disease. Therapeutic options using malaria drugs chloroquine and hydroxychloroquine have shown promising results in vitro and in vivo test. But those efforts have not involved large, carefully-conducted controlled studies that would provide the global medical community the proof that these drugs work on a significant scale. In this way, the present study will evaluate the effectiveness and safety of the use of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in patients hospitalized with pneumonia by SARS-CoV2 virus.

NCT04321278 Coronavirus Infections Pneumonia, Viral Drug: Hydroxychloroquine + azithromycin Drug: Hydroxychloroquine

MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: Evaluation of the clinical status of patients on the 15th day after randomization defined by the Ordinal Scale of 6 points (score ranges from 1 to 6, with 6 being the worst score)

Measure: Evaluation of the clinical status

Time: 15 days after randomization

Secondary Outcomes

Description: All-cause mortality rates at 29 days after randomization

Measure: All-cause mortality

Time: 29 days after randomization

Description: Evaluation of the clinical status of patients on the 7th and 29th day after randomization defined by the Ordinal Scale of 6 points (score ranges from 1 to 6, with 6 being the worst score)

Measure: Evaluation of the clinical status

Time: 7 and 29 days after randomization

Description: Number of days free from mechanical ventilation at 29 days after randomization

Measure: Number of days free from mechanical ventilation

Time: 29 days after randomization

Description: Number of days that the patient was on mechanical ventilation after randomization

Measure: Duration of mechanical ventilation

Time: 29 days after randomization

Description: Length of hospital stay on survivors

Measure: Duration of hospitalization

Time: 29 days after randomization

Description: Presence of other secondary infections

Measure: Other secondary infections

Time: 29 days after randomization

Description: Time from treatment start to death

Measure: Time from treatment start to death

Time: 29 days after randomization

Description: Morbimortality, daily life activities, mental health, and quality of life

Measure: Medium and long-term outcomes of SARS-CoV2 infection on morbimortality, daily life activities, mental health, and quality of life

Time: 3, 6, 9 and 12 months

Description: Leucocyte transcriptome

Measure: Assess whether the tested therapies may be affected by leucocyte phenotype

Time: Baseline

Other Outcomes

Description: Occurrence of QT interval prolongation

Measure: QT interval prolongation

Time: 29 days after randomization

Description: Occurrence of gastrointestinal intolerance

Measure: Gastrointestinal intolerance

Time: 29 days after randomization

Description: Occurrence of laboratory hematimetric parameters, creatinine and bilirubin

Measure: Laboratory abnormalities

Time: 29 days after randomization

Description: Occurrence of adverse events related to the use of the investigational products

Measure: Adverse events

Time: 29 days after randomization

100 The (Norwegian) NOR Solidarity Multicenter Trial on the Efficacy of Different Anti-viral Drugs in SARS-CoV-2 Infected Patients

The (World Health Organization) WHO NOR- (Coronavirus infectious disease) COVID 19 study is a multi-centre, adaptive, randomized, open clinical trial to evaluate the safety and efficacy of hydroxychloroquine, remdesivir and standard of care in hospitalized adult patients diagnosed with COVID-19. This trial will follow the core WHO protocol but has additional efficacy, safety and explorative endpoints.

NCT04321616 SARS-CoV Infection COVID 19 Acute Respiratory Distress Syndrome ARDS Drug: Hydroxychloroquine Drug: Remdesivir Other: (Standard of Care) SoC

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: All cause in-hospital mortality

Measure: In-hospital mortality

Time: 3 weeks

Secondary Outcomes

Measure: Occurrence and duration of mechanical ventilation

Time: 3 weeks

Measure: Occurrence and duration of intensive care unit (ICU) treatment

Time: 3 weeks

Measure: Duration of hospital admittance

Time: 1 month

Measure: 28 Day mortality

Time: 3 weeks

Measure: Viral clearance as assessed by SARS-CoV-2 PCR in peripheral blood and nasopharyngeal airway speciemen

Time: 3 weeks

Measure: Occurrence of co-infections

Time: 3 weeks

Measure: Occurrence of organ dysfunction

Time: 3 months

Other Outcomes

Measure: Inflammatory and anti-inflammatory mediators as assessed in serum and plasma

Time: Throughout hospitalization

Measure: Markers of extracellular matrix remodeling

Time: Throughout hospitalization and 3 months after remission

Measure: Markers of endothelial activation

Time: Throughout hospitalization

Measure: Markers of platelet activation

Time: Throughout hospitalization

101 A PATIENT-CENTRIC OUTCOMES REGISTRY OF PATIENTS WITH KNOWN OR SUSPECTED NOVEL CORONAVIRUS INFECTION SARS-COV-2 (COVID-19)

Background: During the current COVID-19 pandemic there is urgent need for information about the natural history of the infection in non-hospitalized patients, including the severity and duration of symptoms, and outcome from early in the infection, among different subgroups of patients. In addition, a large, real-world data registry can provide information about how different concomitant medications may differentially affect symptoms among patient subgroups. Such information can be invaluable for clinicians managing chronic diseases during this pandemic, as well as identify interventions undertaken in a naturalistic setting that have differential effects. Such factors may include patient diet, over the counter or prescription medications, and herbal and alternative treatments, among others. Identifying the natural disease history in patients from different demographic and disease subgroups will be important for identifying at-risk patients and effectiveness of interventions undertaken in the community. Objectives: The purpose of this study is to understand at the population level the symptomatic course of known or suspected COVID-19 patients while sheltering-in-place or under quarantine. Symptoms will be measured using a daily report derived from the CTCAE-PRO as well as free response. Outcomes will be assessed based on the duration and severity of infection, hospitalization, lost-to-follow-up, or death. As a patient-centric registry, patients themselves may propose, suggest, and/or submit evidence or ideas for relevant collection.

NCT04321811 Coronavirus Other: Observation of patients with known, suspected, or at risk for COVID-19 infection

MeSH:Coronavirus Infections

Primary Outcomes

Description: Daily survey of symptoms known or reported to be associated with COVID-19 infection based including: Headache, Sore throat, Runny nose, Stuffy nose, Gritty/itch eyes, Watery eyes, Nausea, Vomiting, Diarrhea, Sneezing, Coughing, Shortness of breath, Difficulty breathing, Pain or pressure in your chest, Fever, Chills, Body aches, Fatigue, or other issues. Symptoms are rated by participants on a scale of none, mild, moderate, severe, or very severe.

Measure: Define Natural Symptom Course

Time: Cumulative symptom score from first onset of symptoms to resolution of symptoms (realistic timeframe of 14 days)

Secondary Outcomes

Description: Time (in days) from onset of symptoms to hospitalization

Measure: Time to Hospitalization

Time: Realistic timeframe of 14 days

Description: Time (in days) from onset of symptoms to resolution of symptoms

Measure: Time to Symptomatic Recovery

Time: Realistic timeframe of 14 days

102 Personalized Health Education Against the Health Damage of COVID-19 Epidemic in Hungary (PROACTIVE-19)

The additional effect of personalized health education compared to general education following the internationally accepted principles will be evaluated in the prevention of the serious course of the novel coronavirus infection. It is hypothesised that personalized health education provides a greater degree of lifestyle change, thus the risk of a serious course of infection decreases.

NCT04321928 SARS-CoV-2 Coronavirus COVID-19 2019-nCoV 2019nCoV Behavioral: Personalized health education Behavioral: General health education

MeSH:Coronavirus Infections

Primary Outcomes

Description: The primary endpoint will be the composite of the rate of the followings in COVID-19 positive cases (verified by an accredited laboratory): the number of pariticipants with ICU (intensive care unit) admission; 48 hours of hospitalisation and/or death. 48 hours of hospitalisation for the following reasons: (I) arrhythmia (causing hemodynamic instability and requiring continuous monitoring and/or cardiac support, as indicated by mean arterial pressure <65 mm Hg, and/or serum lactate >2 mmol/L) and/or (II) Acute Respiratory Distress Syndrome (ARDS): severe hypoxaemic respiratory failure indicated by a Partial Pressure of Oxygen (PaO2)/Fraction of inspired oxygen (FiO2) <300 mmHg according to the Berlin definition and/or (III) circulatory shock (the requirement of continuous vasopressor support to maintain mean arterial pressure <65 mmHg and/or serum lactate >2 mmol/L)

Measure: Primary composite rate of intensive care unit (ICU) admission, 48 hours of hospital admission, death in COVID-19 positive cases

Time: 12 months

Secondary Outcomes

Description: The number of participants, who required general practitioner visit assessed by the investigator.

Measure: The number of general practitioner visits

Time: 12 months

Description: The number of participants, who required the admission to each type of level of care assessed by the investigator.

Measure: The number of emergency, hospital admission and intensive care admission

Time: 12 months

Description: The time spent in hospital and on the intensive care unit in days collected at the end of the trial from medical records.

Measure: Length of hospitalization and intensive care unit stay

Time: 12 months

Description: The number of cases, where the organ dysfunction (central nervous system, cardiovascular, respiratory, renal, liver, hematological) was present, measured daily during the hospital stay , assessed by the physician at the hospital/ICU.

Measure: Organ dysfunction

Time: 12 months

Description: The reached changes in lifestyle including mental and physical status will be assessed by a questionnaire. The questions related to the coronavirus epidemic in will cover in 3 fields: concerns for self, concerns for family, feeling of being overwhelmed on account of news on the epidemic. The answers can be given by a scale ranging from 1-10 points. Higher score indicates greater level of distress. One question assessess the subjective feeling of being supported, where yes indicates adequate feeling of support and no indicates feeling of being unsupported and/or lonely.

Measure: Lifestyle changes

Time: 12 months

Description: The financial demand of the treatment of COVID-19 infection spent on each patient will be calculated by a healthcare economist after the trial is completed.

Measure: The cost of care

Time: 12 months

103 Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients

Investigational medications adjunct to clinical standard of care treatment will be assessed to evaluate safety and effectiveness as an anti-COVID-19 treatment. All hospitalized persons with moderate to severe COVID-19 disease that meet eligibility criteria will be offered participation.

NCT04321993 COVID-19 Drug: Baricitinib (janus kinase inhibitor)

MeSH:Coronavirus Infections

Primary Outcomes

Measure: Clinical status of subject at day 15 (on a 7 point ordinal scale).

Time: Up to 15 days

Secondary Outcomes

Measure: Status on an ordinal scale assessed daily while hospitalized and on days 15 and 29 and 180.

Time: Up to 180 days

Description: Time to clinical improvement is defined as the time to normalization of respiratory rate, fever, and oxygen saturation, and alleviation of cough within 72 hours.

Measure: Length of time to clinical improvement

Time: Up to 29 days

Measure: Number of participants with normal pulmonary function and normal O2 saturation on days 11, 15 and 29

Time: Up to 29 days

Measure: Number of participants that developed Acute Respiratory Distress Syndrome (ARDS) after treatment

Time: Up to 24 weeks

Description: Time to clinical progression, defined as the time to death, mechanical ventilation, or ICU admission

Measure: Length of time to clinical progression

Time: Up to 29 days

Measure: Cause of death (if applicable)

Time: Up to 24 weeks

Measure: Sequential Organ Failure Assessment (SOFA) score, daily while hospitalized and on days 15 and 29. (Initial, highest, deltas and mean)

Time: Up to 29 days

Description: Fever normalization as defined by: Temperature < 36.6 °C armpit, < 37.2 °C oral, or < 37.8 °C rectal sustained for minimum 24 hours

Measure: Length of time to normalization of fever

Time: Up to 29 days

Description: Oxygen normalization as defined by: peripheral capillary oxygen saturation (Sp02) > 94% sustained minimum 24 hours.

Measure: Length of time to normalization of oxygen saturation

Time: Up to 29 days

Measure: Duration of supplemental oxygen (if applicable)

Time: Up to 29 days

Measure: Duration of mechanical ventilation (if applicable)

Time: Up to 29 days

Measure: Duration of hospitalization

Time: Up to 29 days

Measure: Adverse events

Time: Up to 180 days

Other Outcomes

Measure: Global and SARS-CoV-2-specific immune responses before, during and after intervention and in standard of care treatment arm

Time: Up to 180 days

Measure: Percent of subjects with SARS-CoV-2 detectable in blood at days 3, 5, 8, 11, 15, 29 and 180.

Time: Up to 180 days

Measure: Quantitative SARS-CoV-2 viral load in blood at days 3, 5, 8, and 11, 15, 29, and 180.

Time: Up to 180 days

104 An Open-label, Randomized Controlled Trial of Hydroxychloroquine and Azithromycin for COVID-19 Infection on Hospitalized, Noncritical Patients

Coronavirus (COVID-19) is a somewhat new and recognized infectious disease that is now spreading to several countries in the world, including Brazil. Hydroxychloroquine and azithromycin may be useful for treating those patients. COALITION I study aims to compared standard of care, hydroxychloroquine plus azithromycin and hydroxychloroquine monotherapy for treatment of hospitalized patients with COVID-19. COALITION I will recruit 630 patients with infection by COVID-19 (210 per arm). Ordinal endpoint of status at 15 days will be the primary endpoint.

NCT04322123 Coronavirus Infections Drug: Hydroxychloroquine Oral Product Drug: Hydroxychloroquine + azithromycin

MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Evaluation of the clinical status of patients on the 15th day after randomization defined by the Ordinal Scale of 7 points. Alive at home without limitations on activities Alive at home without limitations on activities In the hospital without oxygen In the hospital using oxygen In the hospital using high-flow nasal catheter or non-invasive ventilation In hospital, on mechanical ventilation Dead

Measure: Evaluation of the clinical status

Time: 15 days after randomization

Secondary Outcomes

Description: Evaluation of the clinical status of patients on the 7th day after randomization defined by the Ordinal Scale of 7 points. Alive at home without limitations on activities Alive at home without limitations on activities In the hospital without oxygen In the hospital using oxygen In the hospital using high-flow nasal catheter or non-invasive ventilation In hospital, on mechanical ventilation Dead

Measure: Ordinal scale in 7 days

Time: 7 days after randomization

Description: Need of intubation and mechanical ventilation up to the 7th day after randomization

Measure: Need of intubation and mechanical ventilation

Time: 7 days after randomization

Description: Use of mechanical ventilation during hospital stay

Measure: Use of mechanical ventilation during hospital stay

Time: 15 days after randomization

Description: Use of non-invasive ventilation up to the 7th day after randomization

Measure: Use of non-invasive ventilation

Time: 7 days after randomization

Description: Hospital Length of Stay

Measure: Hospital Length of Stay

Time: 28 days after randomization

Description: All-cause mortality rates during hospital stay

Measure: All-cause mortality

Time: 28 days after randomization

Description: Occurrence of thromboembolic complications such as: Deep vein thrombosis Pulmonary Embolism Stroke

Measure: Thromboembolic complications

Time: 15 days after randomization

Description: Occurrence of renal dysfunction, defined as an increase in creatinine above 1.5 times the baseline value

Measure: Acute renal disfunction

Time: 15 days after randomization

Description: Number of days alive and free of respiratory support up to 15 days (DAFOR15), defined as the sum of days patients did not require supplementary oxygen, non-invasive ventilation, high-flow nasal catheter neither mechanical ventilation at 15 -days. Patients that perished during the 15-day window will receive zero DAFOR15.

Measure: Number of days alive and free of respiratory support up to 15 days

Time: 15 days

Other Outcomes

Description: Corrected QT interval

Measure: Safety outcome on corrected QT interval

Time: At day 3 and 7 after enrollment

105 An Observational Study of the Use of Siltuximab (SYLVANT) in Patients Diagnosed With COVID-19 Infection Who Have Developed Serious Respiratory Complications

This observational study will collect data from patients treated with siltuximab program for treatment of SARS-CoV-2 infection complicated with serious respiratory complications. This observational study will group the patients into two cohorts receiving siltuximab.. Outcome of patients will be compared to a cohort of patients receiving standard treatment without siltuximab. The patients will be divided into 2 cohorts. Those contained in Cohort A were treated after the use of continuous positive airways pressure (CPAP) or non-invasive ventilation (NIV). Patients in Cohort B were treated after intubation

NCT04322188 Severe Acute Respiratory Syndrome (ARDS) Secondary to SARS-COV-2 Infection

MeSH:Infection Communicable Diseases Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: The main objective of this study is to evaluate mortality in siltuximab treated patients and compare the results with the control cohort

Measure: mortality in siltuximab treated patients

Time: 30 days

Secondary Outcomes

Description: Assess the need of invasive ventilation in siltuximab patients treated in cohort A and compare the results with the control cohort

Measure: the need of invasive ventilation in siltuximab patients Reduction of the need of time of ventilatory support

Time: 30 days

Description: Describe the clinical course of patients treated with siltuximab (Cohort A and B) in terms of ventilatory support and compare the results with the control cohort

Measure: clinical course of patients treated with siltuximab Percentage of patients that undergo to tracheostomy

Time: 30 days

Description: Safety of siltuximab treatment

Measure: Safety Improvement of the lung function assessed by radiologic findings

Time: 30 days

Description: Evaluate the effect of siltuximab on inflammatory parameters (CRP)

Measure: the effect on inflammatory parameters

Time: 30 days

Description: Correlation of outcomes with IL-6 levels

Measure: Correlation of outcomes with IL-6 levels

Time: 30 days

106 Factors Associated With a Positive SARS-CoV-2 Serology in Contact Subjects at High/Moderate Risk of Coronavirus SARS-CoV-2 Infection. (CoV-CONTACT-SERO)

In December 2019, a pneumonia due to a novel coronavirus (SARS-CoV-2) emerged in the city of Wuhan, in China. In a few weeks, the number of confirmed cases of SARS-CoV-2 infection has dramatically increased, with almost 150'000 cases and more than 6'000 reported deaths on March, 16th 2020. Little is known on the rate of human-to-human transmission of this new coronavirus SARS-CoV-2 in the community and within the hospital. Depending on the country, contact subjects considered to be at high or moderate risk of SARS-CoV-2 are, either isolated at home for a period of time defined by the health authorities or, on the contrary, continue their professional activity on the condition that they adopt measures to prevent transmission to those around them. In most European countries, healthcare workers adopt this second option. In all cases, it is most often recommended that contact persons monitor their state of health and communicate it to the persons dedicated to this action. Whether such subjects become spreaders of the virus is not known, nor is the proportion of viral spreader who will develop a symptomatic infection. In this study, we aim to evaluate the virological and clinical outcomes of subjects following a contact at high/moderate risk of SARS-CoV-2 acquisition, in community-subjects and/or healthcare workers. The study population is represented by all subjects who had a contact with laboratory-confirmed SARS-CoV-2 cases and whose contact was considered to be at high/moderate risk of SARS-CoV-2 acquisition. This include both children and adult subjects, subject without social security, and healthcare workers.

NCT04322279 Coronavirus Diagnostic Test: Serology Genetic: Sequencing

MeSH:Coronavirus Infections

Primary Outcomes

Description: Positive serology defined as the presence of SARS-CoV-2 IgM or IgG and assessed by ELISA, microneutralisation assay

Measure: Proportion of subjects with SARS-CoV-2 positive serology at day 30 following the last high/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case.

Time: 30 days (+/-7)

Secondary Outcomes

Description: Positive serology defined as the presence of SARS-CoV-2 IgM or IgG and assessed by ELISA, microneutralisation assay

Measure: Factors associated with a SARS-CoV-2 positive serology at day 30 (+/-7);

Time: 30 days (+/-7)

Description: ELISA, microneutralisation assay

Measure: Time (days) between the first positive SARS-CoV-2 serology and the first negative SARS-CoV-2 serology.

Time: 365 days (+/-30)

107 Efficacy and Safety of Escin as add-on Treatment in Covid-19 Infected Patients

In December 2019,a new type of pneumonia caused by the coronavirus (COVID-2019) broke out in Wuhan ,China, and spreads quickly to other Chinese cities and 28 countries. More than 70000 people were infected and over 2000 people died all over the world. There is no specific drug treatment for this disease. Considering that lung damage is related to both viral infection and burst of cytokines, our idea is to evaluate the efficacy and safety of escin as add-on treatment to conventional antiviral drugs in COVID-19 infected patients.

NCT04322344 Coronavirus Infections Drug: Escin Drug: standard therapy

MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: All cause mortality

Measure: Mortality rate

Time: up to 30 days

Description: mild type：no No symptoms, Radiological examination: no pneumonia; possible mild increase in C-reactive portein 2, moderate type: fever, cough, or other respiratory symptoms. Radiological examination: pneumonia, SpO2＞93% without oxygen inhalation ; increase in C reactive protein, 3: severe type: a. Rate ≥30bpm；b. Pulse Oxygen Saturation (SpO2)≤93% without oxygen inhalation，c. PaO2/FiO2(fraction of inspired oxygen )≤300mmHg ；4. Critically type：match any of the follow: a. need mechanical ventilation; b. shock; c. (multiple organ dysfunction syndrome) MODS

Measure: Clinical status evaluated in agreement with guidelines

Time: up to 30 days

Secondary Outcomes

Description: Pulse Oxygen Saturation(SpO2)＞93%，1. No need for supplemental oxygenation; 2. nasal catheter oxygen inhalation（oxygen concentration%,The oxygen flow rate：L/min）；3. Mask oxygen inhalation（oxygen concentration%,The oxygen flow rate：L/min）；4. Noninvasive ventilator oxygen supply（Ventilation mode,oxygen concentration%,The oxygen flow rate：L/min,）；5. Invasive ventilator oxygen supply（Ventilation mode,oxygen concentration%,The oxygen flow rate：L/min,）

Measure: The differences in oxygen intake methods

Time: up to 30 days

Description: days

Measure: Time of hospitalization (days)

Time: up to 30 days

Description: days

Measure: Time of hospitalization in intensive care units

Time: up to 30 days

Description: forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge

Measure: Pulmonary function

Time: up to 3 months after discharge

108 Proactive Prophylaxis With Azithromycin and hydroxyChloroquine in Hospitalized Patients With COVID: A Randomized, Placebo-controlled Double-blinded Trial Evaluating Treatment With Azithromycin and Hydroxychloroquine to Patients With COVID-19

This study explores whether patients acutely hospitalized may have shorter hospitalization and fewer admittances at Intensive Care Units by treatment with azithromycin and hydroxychloroquine.

NCT04322396 Virus Diseases Infection Viral Corona Virus Infection Drug: Azithromycin Drug: Hydroxychloroquine Drug: Placebo oral tablet Drug: Placebo oral tablet

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Severe Acute Respiratory Syndrome Virus Diseases

Primary Outcomes

Measure: Number of days alive and discharged from hospital within 14 days

Time: 14 days

Secondary Outcomes

Description: The patient will becategorized into one of the following 8 categories depending on status of their hospitalization: Dead (yes/no) Hospitalized and receiving mechanical ventilation or ExtraCorporalMembraneOxygenation (ECMO) (yes/no) Hospitalized and receiving Non-invasive ventilation or "high-flow oxygen device" (yes/no) Hospitalized and given oxygen supplements different from (2) and (3) (yes/no) Hospitalized and without oxygen treatment, but receiving other treatment (both related to COVID-19 or other) (yes/no) Hospitalized for observation (yes/no) Discharged from hospital with restriction of activity level (yes/no) Discharged from hospital without any restrictions of activity level (yes/no) Only one category can be "yes".

Measure: Categorization of hospitalization status

Time: 14 days

Measure: Admitted to intensive care unit, if admitted to ICU then length of stay

Time: 14 days

Measure: Have used Non-invasive ventilation (NIV) during hospitalization

Time: 14 days

Measure: Mortality

Time: 30 days

Measure: Length of hospitalization

Time: 14 days

Measure: Days alive and discharged from hospital

Time: 30 days

Measure: Mortality

Time: 90 days

Measure: Mortality

Time: 365 days

Measure: Number of readmissions (all causes)

Time: 30 days

Measure: Number of days using non-invasive ventilation (NIV)

Time: 14 days

Description: Delta PaO2 measured in arterial puncture

Measure: Change in patient's oxygen partial pressure

Time: 4 days

Description: Delta PaCO2 measured in arterial puncture

Measure: Change in patient's carbondioxid partial pressure

Time: 4 days

Description: pH measured in arterial puncture

Measure: Level of pH in blood

Time: 4 days

Measure: Time for no oxygen supplement (or regular oxygen supplement "LTOT")

Time: 14 days

109 Biomarkers Identification for Diagnosis and Treatment of SARS-COV-2 Infection

Acute lung injury represents the most severe form of the viral infection sustained by coronavirus disease 2019 (Covid-19) also named as SARS-CoV-2, a new virus emerged in December 2019 in Wuhan (China). The diagnosis is clinical and patients develop flu-like syndrome with fever and cough; patients with clinical symptoms can perform a swab test for diagnosis of positivity to Covid-19. Even if diagnosis and treatment are well described, to date, this viral pandemic infection induces an increased mortality in the world. The aim of the present project is to evaluate specific biomarkers that could be used for patient stratification and for tailor therapy in COVID-19 infected patients.

NCT04322513 Coronavirus Diagnostic Test: Biomarkers expression

MeSH:Infection Coronavirus Infections

Primary Outcomes

Description: Change in biomarkers (microRNAs, oxidative stress, Neuron-Specific Enolase, IL-2, IL-6, TNF-alfa, leukocytes, subtypes lymphocytes) in covid-19 positive patients vs covid-negative patients

Measure: Biomarkers expression

Time: up to 30 days

Description: Change in CYP450 expression in covid-19 positive patients that develop adverse drug reactions or drug inefficacy

Measure: Liver Biomarkers expression

Time: up to 30 days

Secondary Outcomes

Description: Changes in biomarkers in covid-19 patients before and after standard treatment

Measure: biomarkers expression (microRNAs, oxidative stress, Neuron-Specific Enolase, IL-2, IL-6, TNF-alfa, leukocytes, subtypes lymphocytes) after treatment

Time: 60 days

110 Colchicine to Counteract Inflammatory Response in COVID-19 Pneumonia

Cytokines and chemokines are thought to play an important role in immunity and immunopathology during virus infections [3]. Patients with severe COVID-19 have higher serum levels of pro-inflammatory cytokines (TNF-α, IL-1 and IL-6) and chemokines (IL-8) compared to individuals with mild disease or healthy controls, similar to patients with SARS or MERS . The change of laboratory parameters, including elevated serum cytokine, chemokine levels, and increased NLR in infected patients are correlated with the severity of the disease and adverse outcome, suggesting a possible role for hyper-inflammatory responses in COVID-19 pathogenesis. Importantly, previous studies showed that viroporin E, a component of SARS-associated coronavirus (SARS-CoV), forms Ca2C-permeable ion channels and activates the NLRP3 inflammasome. In addition, another viroporin 3a was found to induce NLRP3 inflammasome activation . The mechanisms are unclear. Colchicine, an old drug used in auto-inflammatory disorders (i.e., Familiar Mediterranean Fever and Bechet disease) and in gout, counteracts the assembly of the NLRP3 inflammasome, thereby reducing the release of IL-1b and an array of other interleukins, including IL-6, that are formed in response to danger signals. Recently, colchicine has been successfully used in two cases of life-threatening post-transplant capillary leak syndrome. These patients had required mechanically ventilation for weeks and hemodialysis, before receiving colchicine, which abruptly restored normal respiratory function and diuresis over 48 hrs [4].

NCT04322565 Coronavirus Infections Pneumonia, Viral Drug: Colchicine

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: Time to clinical improvement: defined as time from randomization to an improvement of two points from the status at randomization on a seven-category ordinary scale

Measure: Clinical improvement

Time: Day 28

Description: Live discharge from the hospital (whatever comes first)

Measure: Hospital discharge

Time: Day 28

Secondary Outcomes

Description: Number of death patients

Measure: Death

Time: Day 28

Description: 7-category ordinal scale

Measure: Clinical status

Time: Day 7, Day 14

Description: Number of patients with mechanical ventilhation

Measure: Mechanical ventilhation

Time: Day 28

Description: Days of hospitalization

Measure: Hospitalization

Time: Day 28

Description: Days to death from treatment initiation

Measure: Time from treatment initiation to death

Time: Day 28

Description: negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart

Measure: Time to Negativization COVID 19

Time: Day 21

Description: Time to remission of fever in patients with T>37.5°C at enrollment

Measure: Fever

Time: Day 1,4,7,14,21,28

111 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)

This is a phase 3, multi-center, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of colchicine in adult patients diagnosed with COVID-19 infection and have at least one high-risk criterion. Approximately 6000 subjects meeting all inclusion and no exclusion criteria will be randomized to receive either colchicine or placebo tablets for 30 days.

NCT04322682 Corona Virus Infection Drug: Colchicine Drug: Placebo oral tablet

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary endpoint will be the composite of death or the need for hospitalization due to COVID-19 infection in the first 30 days after randomization.

Measure: Number of participants who die or require hospitalization due to COVID-19 infection

Time: 30 days post randomization

Secondary Outcomes

Description: The secondary endpoint is the occurrence of death in the 30 days following randomization.

Measure: Number of participants who die

Time: 30 days post randomization

Description: The secondary endpoint is the need for hospitalization due to COVID-19 infection in the 30 days following randomization.

Measure: Number of participants requiring hospitalization due to COVID-19 infection

Time: 30 days post randomization

Description: The secondary endpoint is the need for mechanical ventilation in the 30 days following randomization.

Measure: Number of participants requiring mechanical ventilation

Time: 30 days post randomization

112 The Efficacy of Natural Honey in Patients Infected With Novel Coronavirus (COVID-19) : A Randomized, Controlled ,Single Masked , Investigator Initiated, Multi-center Trial

The novel coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) has been discovered recently in December 2019 from wuhan city in China to spread in more than 40 countries allover the world. This disease has gain the attention of all nations after it has been stated as a pandemic by the World Health Organization (WHO) in March 12, 2020. Currently no treatment has been proved to be efficient in the treatment of infected patients by COVID-19. Natural honey has been demonstrated as potent antimicrobial in many research investigations and has been considered a good alternative for antiviral drugs for the treatment of some viral infections. The investigators aim to study the efficacy of natural honey in the treatment of COVID-19 patients in this randomized , multicenter, controlled trial, comparing honey in one arm to standard care in the other arm.

NCT04323345 COVID-19 Dietary Supplement: Natural Honey Other: Standard Care

MeSH:Coronavirus Infections

Primary Outcomes

Description: Percentage of patients turned from positive to negative swaps at day 14

Measure: Rate of recovery from positive to negative swaps

Time: 14 days

Description: Number of days till no fever

Measure: Fever to normal temperature in days

Time: 14 days

Description: Number of days till lungs recovery in chest X ray or CT

Measure: Resolution of lung inflammation in CT or X ray

Time: 30 days

Secondary Outcomes

Description: mortality rate in each group at 30 days

Measure: 30 days mortality rate

Time: 30 days

Description: Number of days from initiation of intervention till changing of the swap test result from positive to negative

Measure: Number of days till reaching negative swab results

Time: 30 days

113 Efficacy and Safety of Chloroquine Diphosphate for the Treatment of Hospitalized Patients With Severe Acute Respiratory Syndrome Secondary to SARS-CoV2: a Phase IIb, Double-blind, Randomized Adaptive Clinical Trial

In December 2019, the Municipal Health Committee of Wuhan, China, identified an outbreak of viral pneumonia of unknown cause. This new coronavirus was called SARS-CoV-2 and the disease caused by that virus, COVID-19. Recent numbers show that 222,643 infections have been diagnosed with 9115 deaths, worldwide. Currently, there are no approved therapeutic agents available for coronaviruses. In this scenario, the situation of a global public health emergency and evidence about the potential positive effect of chloroquine (CQ) in most coronaviruses, including SARS-CoV-1, and recent data on small trials on SARS-CoV-2, the investigators intend to investigate the efficacy and the safety of CQ diphosphate in the treatment of hospitalized patients with severe acute respiratory syndrome in the scenario of SARS-CoV2. Preliminary in vitro studies and uncontrolled trials with low number of patients of CQ repositioning in the treatment of COVID-19 have been encouraging. The main hypothesis is that CQ diphosphate will reduce mortality in 50% in those with severe acute respiratory syndrome infected by the SARS-COV2. Therefore, the main objective is to assess whether the use of chloroquine diphosphate reduces mortality by 50% in the study population. The primary outcome is mortality in day 28 of follow-up. According to local contingency plan, developed by local government for COVID-19 in the State of Amazonas, the Hospital Pronto-Socorro Delphina Aziz, located in Manaus, is the reference unit for the admission of serious cases of the new virus. The unit currently has 50 ICU beds, with the possibility of expanding to 335 beds, if needed. The hospital also has trained multiprofessional human resources and adequate infrastructure. In total, 440 participants (220 per arm) will receive either high dose chloroquine 600 mg bid regime (4x150 mg tablets, every 12 hours, D1-D10) or low dose chloroquine 450mg bid regime (3x150mg tablets + 1 placebo tablet every 12 hours on D1, 3x150mg tablets + 1 placebo followed by 4 placebo tablets 12h later from D2 to D5, and 4 placebo tablets every 12 hours, D6-D10). Placebo tablets were used to standardize treatment duration and blind research team and patients. All drugs administered orally (or via nasogastric tube in case of orotracheal intubation). Both intervention and placebo drugs will be produced by Farmanguinhos. Clinical and laboratory data during hospitalization will be used to assess efficacy and safety outcomes.

NCT04323527 SARS-CoV Infection Severe Acute Respiratory Syndrome (SARS) Pneumonia Drug: Chloroquine diphosphate

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia Syndrome

HPO:Pneumonia

Primary Outcomes

Description: proportion of deaths at day 28 between groups compared

Measure: Mortality rate reduction of 50% by day 28

Time: 28 days after randomization

Secondary Outcomes

Description: number of deaths at days 7 and 14 between groups compared

Measure: Absolute mortality on days 7 and 14

Time: 7 and 14 days after first dose

Description: clinical status

Measure: Improvement in overall subject's clinical status assessed in standardized clinical questionnaires on days 14 and 28

Time: 14 and 28 days after first dose

Description: clinical status

Measure: Improvement in daily clinical status assessed in standardized clinical questionnaires during hospitalization

Time: during and after intervention, up to 28 days

Description: supplemental oxygen

Measure: Duration of supplemental oxygen (if applicable)

Time: during and after intervention, up to 28 days

Description: mechanical ventilation

Measure: Duration of mechanical ventilation (if applicable)

Time: during and after intervention, up to 28 days

Description: hospitalization

Measure: Absolute duration of hospital stay in days

Time: during and after intervention, up to 28 days

Description: adverse events grade 3 and 4

Measure: Prevalence of grade 3 and 4 adverse events

Time: during and after intervention, up to 28 days

Description: adverse events

Measure: Prevalence of serious adverse events

Time: during and after intervention, up to 28 days

Description: increase or decrease in serum creatinine compared to baseline

Measure: Change in serum creatinine level

Time: during and after intervention, up to 28 days

Description: increase or decrease in serum troponin I compared to baseline

Measure: Change in serum troponin I level

Time: during and after intervention, up to 28 days

Description: increase or decrease in serum aspartate aminotransferase compared to baseline

Measure: Change in serum aspartate aminotransferase level

Time: during and after intervention, up to 28 days

Description: increase or decrease in serum aspartate aminotransferase compared to baseline

Measure: Change in serum CK-MB level

Time: during and after intervention, up to 28 days

Description: virus clearance from respiratory tract secretion

Measure: Change in detectable viral load in respiratory tract swabs

Time: during and after intervention, up to 28 days

Description: viremia in blood detected through RT-PCR

Measure: Viral concentration in blood samples

Time: during and after intervention, up to 28 days

Description: death

Measure: Absolute number of causes leading to participant death (if applicable)

Time: during and after intervention, up to 28 days

114 Prolonged Low Doses of Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome

COVID-19 infection is overwhelming Italian healthcare. There is an urgent need for a solution to the lack of ICU beds and increasing deaths day after day. A recent retrospective Chinese paper (JAMA Intern Med, online March 13, 2020) showed impressive positive effect of methylprednisolone (MP) on survival of SARS-CoV-2 critically ill patients. Moreover, the Italian Infectious Disease leading institution guidelines for COVID-19 clinical management included as an option for patients with "incipient worsening of respiratory functions" methylprednisolone treatment at an approximate dose of 80mg. The main objective of this multi-centre observational trial is to analyse the association of low dose prolonged infusion of methylprednisolone (MP) for patients with severe acute respiratory syndrome with composite primary end-point (ICU referral, need for intubation, in-hospital death at day 28).

NCT04323592 Severe Acute Respiratory Syndrome (SARS) Pneumonia Coronavirus Infections ARDS, Human Drug: Methylprednisolone Other: standard care

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Respiratory Distress Syndrome, Adult Syndrome

HPO:Pneumonia

Primary Outcomes

Description: We reported below the number of participants meeting at least one of three among death or ICU admission or Invasive mechanical ventilation.

Measure: Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28

Time: 28 days

Description: We reported below the number of participants who died within 28 days, during the hospital stay.

Measure: In-hospital Death Within 28 Days

Time: 28 days

Description: We reported below the number of participants admitted to ICU within 28 days.

Measure: Admission to Intensive Care Unit (ICU)

Time: 28 days

Description: We reported below the number of participants who needed endotracheal intubation during ICU admission

Measure: Endotracheal Intubation (Invasive Mechanical Ventilation)

Time: 28 days

Secondary Outcomes

Description: Change in C-reactive protein after 7 days from baseline. A reduction of CRP reveals a laboratory improvement.

Measure: Change in C-reactive Protein (CRP)

Time: 7 days

Description: number of days free from mechanical ventilation (both invasive and non-invasive) by day 28

Measure: Number of Days Free From Mechanical Ventilation

Time: 28 days

115 Outcomes of Surgery in COVID-19 Infection: International Cohort Study (CovidSurg)

CovidSurg will capture real-world international data, to determine 30-day mortality in patients with COVID-19 infection who undergo surgery. This shared international experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, ultimately improving their clinical care.

NCT04323644 COVID-19 Coronavirus Surgery Procedure: Surgery

MeSH:Coronavirus Infections

Primary Outcomes

Description: Death up to 30-days post surgery

Measure: 30-day mortality

Time: 30 days

Secondary Outcomes

Description: Death up to 7-days post surgery

Measure: 7-day mortality

Time: 7 days post surgery

Description: Reoperation up to 30-days post surgery

Measure: 30-day reoperation

Time: Up to 30-days post surgery

Description: Admission to ICU post surgery

Measure: Postoperative ICU admission

Time: Up to 30 days post surgery

Description: Respiratory failure post surgery

Measure: Postoperative respiratory failure

Time: Up to 30 days post surgery

Description: Acute respiratory distress syndrome post surgery

Measure: Postoperative acute respiratory distress syndrome (ARDS)

Time: Up to 30 days post surgery

Description: Sepsis post surgery

Measure: Postoperative sepsis

Time: Up to 30 days post surgery

116 Convalescent Plasma to Stem Coronavirus: A Randomized, Blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune Plasma) Among Adults Exposed to COVID-19

Evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to Coronavirus disease (COVID-19) at day 28.

NCT04323800 Coronavirus Convalescence Biological: Anti- SARS-CoV-2 Plasma Biological: SARS-CoV-2 non-immune Plasma

MeSH:Coronavirus Infections Convalescence

Primary Outcomes

Description: Comparison of proportions of cumulative incidence of development of SARS-Cov-2 infection (symptoms compatible with infection and/or + molecular testing) regardless of disease severity, following high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to COVID-19.

Measure: Efficacy of treatment at Day 28

Time: Day 28

Description: Cumulative incidence of serious adverse events categorized separately as either severe infusion reactions and Acute Respiratory Distress Syndrome during the study period.

Measure: Safety of treatment with high-titer Anti- SARS-CoV-2 plasma versus control - 1

Time: Up to Day 28

Description: Cumulative incidence of grade 3 and 4 adverse events during the study period

Measure: Safety of treatment with high-titer Anti- SARS-CoV-2 plasma versus control - 2

Time: Up to Day 28

Secondary Outcomes

Description: Cumulative incidence of disease severity between the anti-SARS-CoV-2 convalescent plasma and control groups after individuals develop SARS-CoV-2 infection. Severity of disease will be measured using a clinical event scale of disease severity (evaluated up to Day 28): Death Requiring mechanical ventilation and/or in ICU non-ICU hospitalization, requiring supplemental oxygen; non-ICU hospitalization, not requiring supplemental oxygen; Not hospitalized, but with clinical and laboratory evidence of COVID-19 infection

Measure: Cumulative incidence of disease severity

Time: up to Day 28

Other Outcomes

Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day -1 or day 0 (baseline).

Measure: Anti-SARS-CoV-2 titers Day 0

Time: Day 0

Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day 1.

Measure: Anti-SARS-CoV-2 titers Day 1

Time: Day 1

Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day 7.

Measure: Anti-SARS-CoV-2 titers Day 7

Time: Day 7

Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day 14.

Measure: Anti-SARS-CoV-2 titers Day 14

Time: Day 14

Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day 90.

Measure: Anti-SARS-CoV-2 titers Day 90

Time: Day 90

Description: Compare the rates of SARS-CoV-2 PCR positivity (RT-PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 7, 14 and 28.

Measure: Rates of SARS-CoV-2 PCR positivity

Time: Up to day 28

Description: Compare the duration (days) of SARS-CoV-2 PCR positivity (RT-PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 7, 14 and 28.

Measure: Duration of SARS-CoV-2 PCR positivity

Time: Up to day 28

Description: Compare the peak quantity levels of SARS-CoV-2 RNA amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 1, 7, 14 and 28 days.

Measure: Peak quantity levels of SARS-CoV-2 RNA

Time: Up to day 28

117 PRIORITY (Pregnancy Coronavirus Outcomes Registry)

PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY) is a prospective cohort study of pregnant and recently pregnant women who are: either patients under investigation for COVID-19 or a confirmed case of COVID-19. Data from PRIORITY will be used to evaluate the impact of COVID-19 on the clinical course and pregnancy outcomes of pregnant women and women within 6 weeks of pregnancy.

NCT04323839 Pregnancy Coronavirus COVID-19 Other: Pregnant women under investigation for Coronavirus or diagnosed with COVID-19 Other: Postpartum women under investigation for Coronavirus or diagnosed with COVID-19

MeSH:Coronavirus Infections

Primary Outcomes

Description: presenting symptoms and testing

Measure: Clinical presentation

Time: Baseline to 12 months

Description: Clinical outcomes with resolution of illness

Measure: Disease prognosis outcomes

Time: Baseline to 12 months

Description: Pregnancy outcomes among women infected with COVID-19

Measure: Pregnancy outcomes

Time: Baseline to 12 months

Description: Obstetric outcomes among women infected with COVID-19

Measure: Obstetric outcomes

Time: Baseline to 12 months

Description: Neonatal outcomes among infants born to women with COVID-19

Measure: Neonatal outcomes

Time: Baseline to 12 months

Description: Transmission of COVID-19 from mother to infant

Measure: Modes of transmission of COVID-19

Time: Baseline to 12 months

118 Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients

The overall objective of the study is to determine which treatments (e.g. immune modulator drugs) have the most favorable benefit-risk in adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. The specific aims of this Covid19 cohort are to collect observational data at regular intervals on an ongoing basis in order to embed a series of randomized controlled trials evaluating a various set of interventions for patients with COVID-19 pneumonia. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design.

NCT04324047 Corona Virus Infection

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Overall Survival

Measure: Survival

Time: 14 days

Description: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10

Measure: WHO progression scale COVID 19

Time: 14 days

119 Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Sarilumab Trial - CORIMUNO-19 - SARI

The overall objective of the study is to determine the therapeutic effect and tolerance of Sarilumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Sarilumab is a human IgG1 monoclonal antibody that binds specifically to both soluble and membrane-bound IL-6Rs (sIL-6Rα and mIL-6Rα) and has been shown to inhibit IL-6-mediated signaling through these receptors. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Sarilumab administration to patients enrolled in the CORIMUNO-19 cohort. Sarilumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Sarilumab will receive standard of care. Outcomes of Sarilumab-treated patients will be compared with outcomes of standard of care-treated patients as well as with outcomes of patients treated with other immune modulators.

NCT04324073 Corona Virus Infection Drug: Sarilumab

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Thus, events considered are needing ventilator utilization (including Non Invasive Ventilation, NIV or high flow), or death. New DNR order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.

Measure: Survival without needs of ventilator utilization at day 14.

Time: 14 days

Description: Proportion of patients alive without non-invasive ventilation of high low at day 4 (WHO progression scale ≤ 5). A patient with new DNR order at day 4 will be considered as with a score > 5. WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10

Measure: WHO progression scale <=5 at day 4

Time: 4 days

Measure: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14

Time: 14 days

Description: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 if patients have been intubated before day 14 ; or removal of NIV or high flow (for > 48h) if they were included under oxygen by NIV or High flow (score 6) and remained without intubation. Death or new DNR order (if given after the inclusion of the patient) will be considered as a competing event. Scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9

Measure: WHO progression scale at day 4

Time: 4 days

Secondary Outcomes

Description: WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10

Measure: WHO progression scale

Time: 7 and 14 days

Description: Overall survival

Measure: Survival

Time: 14, 28 and 90 days

Measure: 28-day ventilator free-days

Time: 28 days

Description: arterial blood pH of <7.25 with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours

Measure: respiratory acidosis at day 4

Time: 4 days

Description: evolution of PaO2/FiO2 ratio

Measure: PaO2/FiO2 ratio

Time: day 1 to day 14

Description: time to oxygen supply independency

Measure: time to oxygen supply independency

Time: 14 days

Description: duration of hospitalization

Measure: duration of hospitalization

Time: 90 days

Description: time to negative viral excretion

Measure: time to negative viral excretion

Time: 90 days

Description: time to ICU discharge

Measure: time to ICU discharge

Time: 90 days

Description: time to hospital discharge

Measure: time to hospital discharge

Time: 90 days

120 Anti-Coronavirus Therapies to Prevent Progression of COVID-19, a Randomized Trial

ACT is a randomized clinical trial to assess therapies to reduce the clinical progression of COVID-19.

NCT04324463 Coronavirus Severe Acute Respiratory Syndrome Drug: Colchicine Drug: Interferon-Beta Drug: Aspirin Drug: Rivaroxaban

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: composite of hospitalization or death

Measure: Outpatient trial - Colchicine vs. control and Aspirin vs. control

Time: 45 days post randomization

Description: invasive mechanical ventilation or death

Measure: Inpatient trial - Interferon-β vs. control and Colchicine vs. control

Time: 45 days post randomization

Description: invasive mechanical ventilation or death

Measure: Inpatient trial - Aspirin and rivaroxaban vs. control

Time: 45 days post randomization

Secondary Outcomes

Description: disease progression by 2 points on a 7-point scale

Measure: Outpatient and Inpatient trials - Colchicine vs. control, Interferon-β vs. control

Time: 45 days post randomization

Description: composite of major adverse cardiovascular events (MI, stroke, ALI, VTE, death), and disease progression by 2 points on a 7-point scale

Measure: Outpatient and Inpatient trials - Aspirin vs. control, Aspirin and rivaroxaban vs. control

Time: 45 days post randomization

121 Cytokine Adsorption in Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation

In December 2019 in the city of Wuhan in China, a series of patients with unclear pneumonia was noticed, some of whom have died of it. In virological analyses of samples from the patients' deep respiratory tract, a novel coronavirus was isolated (SARS-CoV-2). The disease spread rapidly in the city of Wuhan at the beginning of 2020 and soon beyond in China and, in the coming weeks, around the world. Initial studies described numerous severe courses, particularly those associated with increased patient age and previous cardiovascular, metabolic and respiratory diseases. A small number of the particularly severely ill patients required not only highly invasive ventilation therapy but also extracorporeal membrane oxygenation (vv-ECMO) to supply the patient's blood with sufficient oxygen. Even under maximum intensive care treatment, a very high mortality rate of approximately 80-100% was observed in this patient group. In addition, high levels of interleukin-6 (IL-6) could be detected in the blood of these severely ill patients, which in turn were associated with poor outcome. From experience in the therapy of severely ill patients with severe infections and respiratory failure, we know that treatment with a CytoSorb® adsorber can lead to a reduction of the circulating pro- and anti-inflammatory cytokines and thus improve the course of the disease and the outcome of the patients. Our primary goal is to investigate the efficacy of treatment with a CytoSorb® adsorber in patients with severe COVID-19 disease requiring venous ECMO over 72 hours after initiation of ECMO. The primary endpoint is the reduction of plasma interleukin-6 levels 72 hours after initiation of ECMO support. As secondary endpoints we investigate 30-day survival, vasopressor and volume requirements, lactate in terms of lactate and platelet function. As safety variables, we further investigate the levels of the applied antibiotics (usually ampicillin and sulbactam).

NCT04324528 Coronavirus COVID-19 SARS-CoV Infection Respiratory Failure Cytokine Storm Device: vv-ECMO + cytokine adsorption (Cytosorb adsorber) Device: vv-ECMO only (no cytokine adsorption)

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Respiratory Insufficiency

HPO:Pneumonia

Primary Outcomes

Description: measurement of IL-6 levels in patient blood after 72 hours of cytokine adsorption (in relation to level before initiation of cytokine adsorption)

Measure: interleukin-6 (IL-6) level after 72 hours

Time: 72 hours

Secondary Outcomes

Description: survival after 30 days

Measure: 30-day-survival

Time: 72 hours

Description: needed dosage of norepinephrine and other vasopressors

Measure: vasopressor dosage

Time: 72 hours

Description: fluid balance levels during cytokine adsorption

Measure: fluid balance

Time: 72 hours

Description: serum-lactate levels during cytokine adsorption

Measure: lactate

Time: 72 hours

122 A Phase I/II Study to Determine Efficacy, Safety and Immunogenicity of the Candidate Coronavirus Disease (COVID-19) Vaccine ChAdOx1 nCoV-19 in UK Healthy Adult Volunteers

A phase I/II single-blinded, randomised, multi-centre study to determine efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in UK healthy adult volunteers aged 18-55 years. The vaccine will be administered intramuscularly (IM).

NCT04324606 Coronavirus Biological: ChAdOx1 nCoV-19 Biological: MenACWY Biological: ChAdOx1 nCoV-19 full boost Biological: ChAdOx1 nCoV-19 half boost Biological: MenACWY boost Drug: Paracetamol

MeSH:Coronavirus Infec Coronavirus Infections

Primary Outcomes

Description: Number of virologically confirmed (PCR positive) symptomatic cases of COVID-19

Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19: Number of virologically confirmed (PCR positive) symptomatic cases

Time: 6 months

Description: Occurrence of serious adverse events (SAEs) throughout the study duration

Measure: Assess the safety of the candidate vaccine ChAdOx1 nCoV: Occurrence of serious adverse events (SAEs)

Time: 6 months

Secondary Outcomes

Description: Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination

Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited local reactogenicity signs and symptoms

Time: 7 days following vaccination

Description: Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination

Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited systemic reactogenicity signs and symptoms

Time: 7 days following vaccination

Description: Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination

Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of unsolicited adverse events (AEs)

Time: 28 days following vaccination

Description: Change from baseline for safety laboratory measures (haematology and biochemistry blood results)

Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV through standard blood tests

Time: 6 months

Description: Occurrence of disease enhancement episodes

Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV by measuring the number of disease enhancement episodes

Time: 6 months

Description: Number of deaths associated with COVID-19

Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19

Time: 6 months

Description: Number of hospital admissions associated with COVID-19

Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19

Time: 6 months

Description: Number of intensive care unit admissions associated with COVID-19

Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19

Time: 6 months

Description: Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study

Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates

Time: 6 months

Description: Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein

Measure: Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays

Time: 6 months

Description: Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)

Measure: Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19

Time: 6 months

Other Outcomes

Description: Virus neutralising antibody (NAb) assays against live and/or pseudotype SARS-CoV-2 virus

Measure: Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through Virus neutralising antibody assays

Time: 6 months

Description: All safety, reactogenicity, immunogenicity and efficacy endpoints

Measure: Assess safety, reactogenicity, immunogenicity and efficacy endpoints, for participants receiving prophylactic paracetamol

Time: 6 months

Description: Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) post boost

Measure: Assess immunogenicity of ChAdOx1 nCoV-19 given as homologous prime-boost

Time: 6 months

123 "Coronavirus SARS-CoV2 and Diabetes Outcomes" : CORONADO

COVID-19 (Coronavirus Disease-2019) is a life-threatening infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that appeared in December 2019 in the Wuhan district. COVID-19 has since affected more than 150 countries across the world and especially France. The first epidemiological data, mostly from Chinese studies, indicate that diabetes is one of the most common comorbidities, with high blood pressure, in patients with COVID-19. Moreover, the presence of diabetes at admission would be a risk factor for both ICU hospitalization and death. Nevertheless, specific data on people with diabetes and COVID-19 are fragmentary, justifying the achievement of a dedicated prospective observational study. The French nationwide CORONADO study aims to specifically describe the phenotypic characteristics of patients with diabetes admitted to hospital with COVID-19 infection. Particular attention will be devoted to glycemic control at admission (i.e. the level of HbA1c), the diabetic complications, as well as anti-diabetic and antihypertensive therapies. This study will provide answers to caregivers and patients with diabetes regarding the risk factors related to diabetes for COVID-19 prognosis. This pilot study will be used for the development of new studies and for the establishment of recommendations for the cost of care in patients with diabetes and COVID-19.

NCT04324736 Coronavirus Diabetes Other: no interventional study

MeSH:Coronavirus Coronavirus Infections Diabetes Mellitus

HPO:Diabetes mellitus

Primary Outcomes

Description: Prevalence of severe forms among all COVID-19 patients with diabetes

Measure: Assess the prevalence of severe forms among hospitalized patients with diabètes and COVID-19

Time: 1 month

Secondary Outcomes

Description: Use the body weight, type of diabetes, tglycemic control (HbA1C at admission), the comorbidities and complications associated with diabetes and finally the usual therapies.

Measure: describe the clinical and biological characteristics of hospitalized subjects with diabetes and COVID-19

Time: 1 month

Description: death at 7 days after admission, hospital death and date of death, total length of hospitalization and discharge procedures, serious form requiring the use of artificial ventilation with tracheal intubation and date of use of this treatment, decision to limit

Measure: describe the prognosis of hospitalized subjects with diabetes and COVID-19

Time: 1 month

Description: care service where the patient is taken care of, insulin therapy (IVSE or multi-injection) and dose of insulin required on D2 and D7

Measure: describe the care management of hospitalized subjects with diabetes and COVID-19

Time: 1 month

124 Prevalence and Incidence of COVID-19 Infection in Patients With Chronic Plaque Psoriasis on Immunosuppressant Therapy

This study will assess the prevalence and incidence of COVID-19 infection in patients with chronic plaque psoriasis on immunosuppressant therapy.

NCT04324866 Coronavirus Infection Diagnostic Test: Nasopharyngeal swab

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Psoriasis

HPO:Palmoplantar pustulosis Psoriasiform dermatitis

Primary Outcomes

Measure: Point prevalence of COVID-19 infection

Time: Baseline up to 6 months

Secondary Outcomes

Measure: Incidence of COVID-19 infection

Time: Baseline up to 6 months

Measure: Percentage of subjects presenting fever or respiratory symptoms

Time: Baseline up to 6 months

Measure: Evaluate the relationship between COVID-19 infection and chronic pharmacological treatments

Time: Baseline up to 6 months

Measure: Evaluate the relationship between COVID-19 infection and comorbid medical conditions

Time: Baseline up to 6 months

125 Single-Arm Observational Study Designed to Clinically Evaluate Cordio Application in Adult Patients Positive to COVID-19

Study on adult patients positive to COVID-19 virus. After signing informed consent and undergoing screening assessments, eligible patients will record few times a day several pre-defined sentences to the Cordio App installed in a smartphone/tablet. The app will upload the vocal data to the sponsor's servers for analysis. The patient will record at hospital admittance (COVID-19 positive) until patient defined as COVID-19 negative and free of relevant clinical symptoms.

NCT04325048 Coronavirus Infection Device: Cordio App

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: patient voice that is recorded during the study will be anylaysis with specific algorithms

Measure: Voice anaysis

Time: 1-2 years

126 Cardiac complicAtions in Patients With SARS Corona vIrus 2 regisTrY

CAPACITY (www.capacity-covid.eu) is a registry of patients with COVID-19 across Europe and has been established to answer questions on the role of cardiovascular disease in this pandemic. It is an extension of the Case Record Form (CRF) that was released by the ISARIC (International Severe Acute Respiratory and Emerging Infection Consortium) and WHO (World Health Organisation) in response to the emerging outbreak of COVID-19.

NCT04325412 COVID-19; Cardiovascular Diseases

MeSH:Coronaviru Coronavirus Infections Cardiovascular Diseases

HPO:Abnormality of the cardiovascular system

Primary Outcomes

Measure: The incidence of cardiovascular complications in patients with COVID-19

Time: 30 days

127 Sero-epidemiological Study of the SARS-CoV-2 Virus in France: Constitution of a Collection of Human Biological Samples

On January 2020, the discovery of a new coronavirus (SARS-CoV-2) was officially announced by the Chinese health authorities and the World Health Organization (WHO). Its complete genome was sequenced by the laboratory of respiratory infection viruses at the Institut Pasteur on 29 January 2020 in France. This will allow the identification of antigenic structures involved in the immune response and the development of serological diagnostic tests. Many questions are being asked about this new virus and the infection it causes, including questions about the percentage of asymptomatic and pauci-symptomatic forms. Serological studies can provide answers to these questions. There is no serological test for SARS-COV-2 yet, but the laboratory of respiratory infection viruses at the Institut Pasteur is working on its development. This study proposes to carry out a collection of samples taken from subjects who travelled to China before the epidemic outbreak or suspected of being infected with SARS-CoV-2. As soon as it is available, serology will be performed on the collected samples.

NCT04325646 SARS (Severe Acute Respiratory Syndrome) COVID-19 Other: Human Biological samples

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: Description of the serological status of individuals by different detection tests

Measure: Presence of specific anti-SARS-CoV-2 antibodies in the different study groups.

Time: One year

Secondary Outcomes

Description: Proportion of asymptomatic subjects into seropositive population

Measure: Percentage of asymptomatic forms in individuals with anti-SARS-CoV-2 antibodies

Time: One year

128 Convalescent Plasma to Limit Coronavirus Associated Complications: An Open Label, Phase 2A Study of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19

Researchers are trying to assess the treatment potential and safety of anti-SARS-CoV-2 convalescent plasma in patients with acute respiratory symptoms with confirmed COVID-19.

NCT04325672 Coronavirus Biological: Convalescent Plasma

MeSH:Coronavirus Infections

Primary Outcomes

Description: Change in RNA levels of SARS-CoV-2 from nasopharyngeal using RT-PCR (reverse transcriptase polymerase chain reaction) across time.

Measure: RNA in SARS-CoV-2

Time: Days 0, 1, 3, 7, 14, 28, 60 and 90 after transfusion

Description: Total number of subjects to be admitted to the ICU after the anti-SARS-CoV-2 convalescent plasma transfusion.

Measure: ICU Admissions

Time: 90 days after transfusion

Description: Total number of subject deaths.

Measure: Hospital Mortality

Time: 90 days after transfusion

Description: The total number of days subjects were admitted to the hospital.

Measure: Hospital Length of Stay (LOS)

Time: 90 days after transfusion

Secondary Outcomes

Description: The type of supplemental oxygen support (e.g. nasal cannula, high flow nasal cannula, noninvasive ventilation, intubation and invasive mechanical ventilation, rescue ventilation) of the anti-SARS-CoV-2 convalescent plasma group across time.

Measure: Type of respiratory support

Time: 90 days after transfusion or until hospital discharge (whichever comes first)

Description: The total number of days subjects required respiratory support.

Measure: Duration of respiratory support

Time: 90 days after transfusion or until hospital discharge (whichever comes first)

129 Hydroxychloroquine Versus Placebo in Patients Presenting COVID-19 Infection and at Risk of Secondary Complication: a Prospective, Multicentre, Randomised, Double-blind Study

A new human coronavirus responsible for pneumonia, SARS-CoV-2, emerged in China in December 2019 and has spread rapidly. COVID-19, the disease caused by this virus, has a very polymorphous clinical presentation, which ranges from upper respiratory tract infections to acute respiratory distress syndrome. It may appear serious straightaway or may evolve in two stages, with a worsening 7 to 10 days after the first clinical signs, potentially linked to a cytokine storm and accompanied by a high risk of thrombosis. The global mortality rate of COVID-19 is between 3% and 4%, with severe forms being more frequent among older patients. Management is symptomatic as no antiviral treatment has demonstrated any clinical benefit in this condition. Hydroxychloroquine is a derivative of chloroquine commonly used in some autoimmune diseases, such as systemic lupus erythematosus. It is active in vitro in cellular models of infection by many viruses such as HIV, hepatitis C or SARS-CoV. However, its interest in viral infections in humans has not been demonstrated. Very recently, a preliminary uncontrolled study evaluated the effect of hydroxychloroquine on viral shedding in subjects with COVID-19. Among 20 patients treated with hydroxychloroquine at a dose of 600 mg per day, the percentage of patients with detectable SARS-CoV-2 RNA in the nasopharynx decreased from 100% at inclusion (start of treatment) to 43% six days later. In comparison, 15 of 16 untreated patients had a positive RT-PCR six days after inclusion. Furthermore, hydroxychloroquine has immunomodulating and anti-inflammatory properties, which could theoretically prevent or limit secondary worsening. The research hypothesis is that treatment with hydroxychloroquine improves prognosis and reduces the risk of death or use for invasive ventilation in patients with COVID-19.

NCT04325893 Coronavirus Drug: Hydroxychloroquine Drug: Placebo

MeSH:Coronavirus Infections

Primary Outcomes

Measure: Number of death from any cause, or the need for intubation and mechanical ventilation during the 14 days following inclusion and start of treatment.

Time: Day 14

Secondary Outcomes

Measure: Number of death from any cause, or the need for intubation and mechanical ventilation during the 28 days following inclusion and start of treatment.

Time: Day 28

Description: WHO Ordinal Scale for Clinical Improvement ranges from 0 to 8, higher score meaning poorer outcome

Measure: Clinical evolution on the WHO Ordinal Scale for Clinical Improvement for COVID-19 between day 0 and day 14

Time: Day 14

Description: WHO Ordinal Scale for Clinical Improvement ranges from 0 to 8, higher score meaning poorer outcome

Measure: Clinical evolution on the WHO Ordinal Scale for Clinical Improvement for COVID-19 between day 0 and day 28.

Time: Day 28

Measure: Number of all-cause mortality at day 14

Time: Day 14

Measure: Number of all-cause mortality at day 28

Time: Day 28

Measure: Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal samples at day 5

Time: Day 5

Measure: Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal samples at day 10

Time: Day 10

Measure: The rate of venous thromboembolic events at day 28, documented and confirmed by an adjudication committee.

Time: Day 28

Measure: Number of all-cause mortality at day 28 in patients aged 75 and older

Time: day 28

Measure: Clinical evolution on the WHO OSCI scale for COVID-19 between day 0 and day 28 for patients aged 75 or older

Time: day 28

Measure: Rate of severe adverse events at day 28

Time: day 28

Measure: Number of all-cause mortality at day 14 in patients aged 75 and older

Time: day 14

130 Early Prone Positioning Combined With High-Flow Nasal Cannula Versus High-Flow Nasal Cannula in COVID-19 Induced Moderate to Severe ARDS

Coronavirus disease 2019 (COVID-19) is an emerging infectious disease that was first reported in Wuhan, China, and had subsequently spread worldwide. Twenty-nine percent of COVID-19 patients may develop ARDS. Based on the potential beneficial mechanisms of HFNC and PP, whether early use of prone positioning combined with HFNC can avoid the need for intubation in COVID-19 induced moderate to severe ARDS patients needs to be further investigated.

NCT04325906 Prone Positioning High Flow Nasal Cannula Acute Respiratory Distress Syndrome Corona Virus Infection Device: high flow nasal cannula (HFNC) Procedure: Prone positioning (PP)

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: the treatment failure rate of HFNC/HFNC+PP support and clinical requirement for advanced respiratory support

Measure: Treatment failure

Time: 28 days

Measure: Intubation rate

Time: 28 days

Secondary Outcomes

Description: the improvement of SpO2/FIO2 or PaO2/FiO2 from HFNC alone to HFNC+PP

Measure: Efficacy of PP

Time: 28 days

131 Comprehensive Clinical, Virological, Microbiological, Immunological and Laboratory Monitoring of Patients Hospitalized With Coronavirus Disease 2019 (COVID-19)

COVID-19 may cause another world-wide epidemic. This study is divided into 2 arms: (1) Prospective longitudinal observational study involving patients with laboratory-confirmed COVID-19 and (2) Retrospective study on patients with laboratory-confirmed COVID-19. Arm 1: We will collect EDTA blood, stool samples, rectal swab, urine, saliva, and specimens from upper respiratory tract (nasopharyngeal aspirate or flocked swab), and lower respiratory tract (sputum or tracheal aspirate) on daily, alternate day, or weekly basis as appropriate. Arm 2: The remainder of specimens that were submitted for laboratory investigation as part of clinical management will be retrieved. Those specimens will only be used after all clinically indicated testing and confirmation procedures have been completed. Assistance from the Public Health Laboratory Service, Department of Health, will be invited to retrieve samples as well as participate in this study. Patients hospitalized for pneumonia in medical wards and ICU at the Prince of Wales Hospital tested negative for COVID-19 will be recruited as controls. Understanding the clinical, virological, microbiological and immunological profiles of this infection is urgently needed to facilitate its management and control.

NCT04325919 Coronavirus Infections Other: No intervention

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Patients' treatment and management during hospitalization.

Measure: Clinical

Time: 6 months

Description: Serial viral load changes during hospitalization.

Measure: Virological

Time: 6 months

Description: Alterations in fecal microbiota composition (including virome, bacteria and fungi) in COVID-19 patients compared with healthy controls.

Measure: Microbiological

Time: 6 months

132 Use of cSVF For Residual Lung Damage (COPD/Fibrotic Lung Disease After Symptomatic COVID-19 Infection For Residual Pulmonary Injury or Post-Adult Respiratory Distress Syndrome Following Viral (SARS-Co-2) Infection

COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure and functionality. A short review includes: - Early December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office. - January 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern. - February 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus. - February 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19. - February 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives.. - March 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland. - March 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control." March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up.. March 24th, 2020 - Hot spots are evolving and identified, particularly in the areas of New York-New Jersey, Washington, and California. Immediate attention is turned to testing, diagnosis, epidemiological containment, clinical trials for drug testing started, and work on a long-term vaccine started. The recovering patients are presenting with mild to severe lung impairment as a result of the viral attack on the alveolar and lung tissues. Clinically significant impairment of pulmonary function appears to be a permanent finding as a direct result of the interstitial lung damage and inflammatory changes that accompanied. This Phase 0, first-in-kind for humans, is use of autologous, cellular stromal vascular fraction (cSVF) deployed intravenously to examine the anti-inflammatory and structural potential to improve the residual, permanent damaged alveolar tissues of the lungs.

NCT04326036 Pulmonary Alveolar Proteinosis COPD Idiopathic Pulmonary Fibrosis Viral Pneumonia Coronavirus Infection Interstitial Lung Disease Procedure: Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Device: Centricyte 1000 Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution Drug: Liberase Enzyme (Roche) Drug: Sterile Normal Saline for Intravenous Use

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Lung Diseases Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Lung Diseases, Interstitial Pulmonary Alveolar Proteinosis

HPO:Abnormal lung morphology Interstitial pneumonitis Interstitial pulmonary abnormality Intraalveolar phospholipid accumulation Pulmonary fibrosis

Primary Outcomes

Description: Reporting of Adverse Events or Severe Adverse Events Assessed by CTCAE v4.0

Measure: Incidence of Treatment-Emergent Adverse Events

Time: 1 month

Secondary Outcomes

Description: High Resolution Computerized Tomography of Lung (HRCT Lung) for Fluidda Analysis comparative at baseline and 3 and 6 months post-treatment comparative analytics

Measure: Pulmonary Function Analysis

Time: baseline, 3 Month, 6 months

Description: Finger Pulse Oximetry taken before and after 6 minute walk on level ground, compare desaturation tendency

Measure: Digital Oximetry

Time: 3 months, 6 months

133 Audio Data Collection for Identification and Classification of Coughing

An open access study that will define and collect digital measures of coughing in multiple populations and public spaces using various means of audio data collection.

NCT04326309 COVID-19 Coronavirus Infections Hay Fever Asthma Chronic Obstructive Pulmonary Disease Influenza Common Cold Respiratory Tract Infections Healthy

MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Common Cold Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive

HPO:Chronic pulmonary obstruction Pulmonary obstruction Respiratory tract infection

Primary Outcomes

Description: Size of collected audio dataset measured as number of collected cough sounds, targeting ≥10,000 identified coughs.

Measure: Dataset size

Time: 14 days

Secondary Outcomes

Description: Identification of cough sounds by the existing mathematical model with ≥ 99% specificity and ≥ 60% sensitivity

Measure: Cough sound identification

Time: 14 days

Description: Increase in the sensitivity of the mathematical model to cough sounds to ≥ 70% while retaining the specificity of ≥ 99%

Measure: Improvement of the existing model

Time: 14 days

Description: Determination of the level of acceptance and satisfaction of the solution by patients by means of a Standard Usability Questionnaire to provide feedback. The score ranges from 10 to 50, higher score indicating a better usability.

Measure: Evaluate the usability of the application

Time: 14 days

134 Evaluation of Novel Diagnostic Tests for 2019-nCOV

COVID-19 (also known as Coronavirus) originated in the Wuhan China and has since spread to at least 159 countries around the world. It was declared a pandemic by the World health organisation on the 11th of March 2020. The cases in the United Kingdom continue to increase exponentially with up to 5 683 people diagnosed as on the 22nd of March 2020. It is estimated that 1 in 5 people diagnosed will require hospital admission and 1 in 20 intensive care treatment. By developing and improving diagnostic testing, we can accurately diagnose infected cases to triage appropriate treatments, identify individuals for quarantine in order to prevent transmission and obtain information regarding patient's immune systems. At present, the diagnostic test is a highly specific method of genetic amplification called 'Reverse Transcription - Polymerase Chain Reaction' or RT-PCR, which allows detection of very small amounts of genetic mutations caused by the COVID-19 virus. However, this method must be completed in highly specialised facilities, which are few and far between, increasing time to diagnosis (currently 48-72 hours), increasing exposure to non-infected individuals, and overburdening the analysing facilities. The ideal solution is a point of care (POC) test that can give results immediately. This study aims to harness the point of care technology of the SAMBA II device (Diagnostics for the Real World Ltd.), which is a CE-marked device that has been used with success in the identification of Human Immunodeficiency Virus (HIV), by amplifying genetic material without the need to increase and decrease temperatures during the amplification process. In the COVIDx study, 200 patients meeting the Public Health England's (PHE) inpatient definition of having suspected COVID-19 will be approached, consented and a sample from throat and nasal swab (combined) or tracheal fluid taken and tested using the SAMBA II method. A combination of the standard PHE RT-PCR and an additional validated laboratory PCR technique will be used as a control in line with standard clinical practice. Patients will undergo an additional serum tests on existing samples as made available after routine clinical assessments to monitor antibody response. Patients will be followed for clinical outcomes at 28 days post-admission.

NCT04326387 Acute Disease Coronavirus Respiratory Viral Infection Diagnostic Test: SAMBA II (Diagnostic for the Real World) Diagnostic Test: Public Health England Gold Standard Diagnostic Test: Cambridge Validated Viral Detection Method Diagnostic Test: Radiological Detection

MeSH:Coronavirus Infections Acute Disease Virus Diseases

Primary Outcomes

Description: Measuring the diagnostic accuracy of the SAMBA II POC-sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) tested against a dual composite reference standard

Measure: SAMBA COVID-19 POC PCR Test

Time: 28 days

Secondary Outcomes

Description: Evaluating the participant acceptability of the SAMBA swab intervention using a participant reported discomfort scale

Measure: Patient acceptability

Time: 28 days

Description: Time to positive IgM/IgG test positivity

Measure: Immune Response Positivity

Time: 40 days

135 Active Monitoring And Determinants of Incidence Infection of COVDI-19 in a Hospital Population (AMADIICH) Study Protocol

7. Objectives To apply e-health methods to perform active monitoring and assess determinants of incident Infection of COVID-19 in a hospital population. 8. Study design Prospective, Single-centre, observational clinical study. 9. Disease or disorder under study Healthy people in risk of COVID-19 infection. 10. Main variable. Symptoms related to infection caused by SARS-Cov2. 11. Study population and total number of patients Men and women in general god health status aged between 18 and 80 years that currently are employees of Hospital de La Princesa . 12. Duration of treatment Each subject will be monitored, since its recruitment, for a period of 12 weeks. 13. Timetable and expected date of completion The overall duration of the study is estimated at about 6 months, from patient recruitment to the last data recorded by last subject. The aim is to carry out this study from March 2020 onwards.

NCT04326400 Coronavirus Infection

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary objective of this trial is to investigate whether the use of a cell phone App-based platform is a useful tool to monitor the symptoms of a population in risk of SARS-Cov2 infection. The final aim is to assess determinants of incidence of infection of COVID-19 in people working in Hospital during the pandemia of SARS-Cov-2.

Measure: COVID-19 App-based platform

Time: 6 months

Secondary Outcomes

Description: To monitor in real-time COVID-19 symptoms in the hospital workforce, which are a proxy of incident infection (Step 1) To identify in real-time clusters of COVID-19 symptoms and to facilitate control measures. To determine the incidence of new infection of COVID-19. To identify the determinants and risk/protective factors associated with this infection, in a workforce hospital population free of COVID-19 at the start of our study.

Measure: COVID-19 infection

Time: 6 months

136 ODYSSEY: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Treating Inflammatory Lung Injury and Improving Clinical Outcomes Associated With Severe or Critical COVID-19 Infection

This is a randomized, double-blind placebo-controlled trial to investigate the efficacy and safety of tradipitant 85 mg orally given twice daily to treat inflammatory lung injury associated with severe or critical COVID-19 infection. On evaluation for enrollment, participant will need to meet all inclusion and exclusion criteria. If participant consents, they will be randomized 1:1 to treatment with either tradipitant 85 mg PO BID or placebo in addition to standard of care for COVID-19 infection as per the protocol at the treating hospital. NEWS 2 will be assessed at screening and daily following randomization. Inflammatory lab markers as detailed should be collected once per day in the morning, preferably at the same time every morning. All enrolled participants will have whole blood collected for whole genome sequencing.

NCT04326426 Coronavirus Infection Drug: Tradipitant Drug: Placebo

MeSH:Infection Co Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Time to improvement on a 7-point ordinal scale as compared to baseline

Time: 14 days or discharge

Secondary Outcomes

Measure: Treatment and prevention of inflammatory lung injury as measured by change in baseline of interleukin-6 (IL-6)

Time: 14 days or discharge

Measure: Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples

Time: 14 days or discharge

Measure: In-hospital mortality

Time: 14 days or discharge

Measure: Mean change in NEWS2 score from baseline

Time: 14 days or discharge

Measure: Understand the effect of genetics for treatment response through whole genome sequence of the participant and the COVID-19 virus

Time: 14 days or discharge

Measure: Reduction from baseline of NRS for cough

Time: 14 days or discharge

Measure: Reduction from baseline of NRS for nausea

Time: 14 days or discharge

Measure: Time to normalization of fever for at least 48 hours

Time: 14 days or discharge

Measure: Time to improvement in oxygenation for at least 48 hours

Time: 14 days or discharge

137 The Use of a Bidirectional Oxygenation Valve in the Management of Respiratory Failure Due to COVID-19 Infection

This study will utilize a single center internal control study design. The objective of this study is to determine the feasibility and safety of a bidirectional oxygenation PEEP generating mouthpiece when combined with oxygen by non-rebreather face mask, compared to support by oxygen non-rebreather face mask alone.

NCT04326452 Coronavirus Infection Device: bidirectional oxygenation mouthpiece

MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary endpoint for this feasibility study is pulse oximetry level after treatment with a Bidirectional Oxygenation Valve

Measure: Pulse oximetry level

Time: Change from Baseline pulse oximetry level at 15 minutes post treatment

Secondary Outcomes

Measure: Respiratory rate

Time: Change from Baseline clinical measurements at 15 minutes post treatment

Measure: Heart rate

Time: Change from Baseline clinical measurements at 15 minutes post treatment

Measure: Blood pressure

Time: Change from Baseline clinical measurements at 15 minutes post treatment

Description: Venous and arterial blood gases, if available, will be combined to report systemic carbon dioxide.

Measure: Systemic carbon dioxide

Time: Change from Baseline clinical measurements at 15 minutes post treatment

138 Proflaxis for Healthcare Professionals Using Hydroxychloroquine Plus Vitamin Combining Vitamins C, D and Zinc During COVID-19 Pandemia: An Observational Study

Healthcare professionals mainly doctors, nurses and their first degree relatives (spouse, father, mother, sister, brother, child) who have been started hydroxychloroquine(plaquenil) 200mg single dose repeated every three weeks plus vitaminC including zinc once a day were included in the study. Study has conducted on 20th of march. Main purpose of the study was to cover participants those who are facing or treating COVID19 infected patients in Ankara.

NCT04326725 Pneumonitis Coronavirus Infection Drug: Plaquenil 200Mg Tablet

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: persons who took this medication should not have an infection

Measure: Protection against COVID-19

Time: 4 months

139 BCG Vaccination to Reduce the Impact of COVID-19 in Healthcare Workers Following Coronavirus Exposure (BRACE) Trial

Phase III, two-group multicentre, randomised controlled trial in up to 10 078 healthcare workers to determine if BCG vaccination reduces the incidence and severity of COVID-19 during the 2020 pandemic.

NCT04327206 Coronavirus Disease 2019 (COVID-19) Respiratory Illness Corona Virus Infection COVID-19 Drug: BCG Vaccine Drug: 0.9%NaCl

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of participants with COVID-19 disease defined as positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)

Measure: COVID-19 disease incidence

Time: Measured over the 6 months following randomisation

Description: Number of participants with severe COVID-19 disease, defined as: COVID-19 disease with hospitalisation, death, or non-hospitalised severe disease. Non-hospitalised severe disease is defined as non-ambulant (*) for ≥ 3 consecutive days OR unable to work (**) for ≥ 3 consecutive days. (*) "pretty much confined to bed (meaning finding it very difficult to do any normal daily activities". (**) "I do not feel physically well enough to go to work"

Measure: Severe COVID-19 disease incidence

Time: Measured over the 6 months following randomisation

Secondary Outcomes

Measure: COVID-19 incidence by 12 months

Time: Measured over the 12 months following randomisation

Description: Number of participants with severe COVID-19 disease, defined as: COVID-19 disease with hospitalisation, death, or non-hospitalised severe disease. Non-hospitalised severe disease is defined as non-ambulant(*) for ≥ 3 consecutive days OR unable to work (**) for ≥ 3 consecutive days. * "pretty much confined to bed (meaning finding it very difficult to do any normal daily activities" ** "I do not feel physically well enough to go to work"

Measure: Severe COVID-19 incidence by 12 months

Time: Measured over the 12 months following randomisation

Description: Time to first symptom of COVID-19 in a participant who subsequently meets the case definition: positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)

Measure: Time to first symptom of COVID-19

Time: Measured over the 12 months following randomisation

Description: Number of episodes of COVID-19 disease defined as positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)

Measure: Episodes of COVID-19

Time: Measured over the 12 months following randomisation

Description: Number of participants with asymptomatic SARS-CoV-2 infection defined as Evidence of SARS-CoV-2 infection (by PCR or seroconversion) Absence of respiratory illness (using self-reported questionnaire) No evidence of exposure prior to randomisation (inclusion serology negative)

Measure: Asymptomatic SARS-CoV-2 infection

Time: Measured over the 12 months following randomisation

Description: Number of days (using self-reported questionnaire) unable to work (excludes quarantine/workplace restrictions) due to COVID-19 disease defined as positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)

Measure: Work absenteeism due to COVID-19

Time: Measured over the 12 months following randomisation

Description: Number of days confined to bed (using self-reported questionnaire) due to COVID-19 disease defined as positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)

Measure: Bed confinement due to COVID-19

Time: Measured over the 12 months following randomisation

Description: Number of days with symptoms in any episode of illness that meets the case definition for COVID-19 disease: positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)

Measure: Symptom duration of COVID-19

Time: Measured over the 12 months following randomisation

Description: Number of pneumonia cases (abnormal chest X-ray) (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test

Measure: SARS-CoV-2 pneumonia

Time: Measured over the 12 months following randomisation

Description: Need for oxygen therapy (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test

Measure: Oxygen therapy with SARS-CoV-2

Time: Measured over the 12 months following randomisation

Description: Number of admission to critical care (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test

Measure: Critical care admissions with SARS-CoV-2

Time: Measured over the 12 months following randomisation

Description: Number of days admitted to critical care (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test

Measure: Critical care admission duration with SARS-CoV-2

Time: Measured over the 12 months following randomisation

Description: Number of participants needing mechanical ventilation (using self-reported questionnaire and/or medical/hospital records) and a positive SARS-CoV-2 test

Measure: Mechanical ventilation with SARS-CoV-2

Time: Measured over the 12 months following randomisation

Description: Number of days that participants needed mechanical ventilation (using self-reported questionnaire and/or medical/hospital records) and a positive SARS-CoV-2 test

Measure: Mechanical ventilation duration with SARS-CoV-2

Time: Measured over the 12 months following randomisation

Description: Number of days of hospitalisation due to COVID-19 (using self-reported questionnaire and/or medical/hospital records).

Measure: Hospitalisation duration with COVID-19

Time: Measured over the 12 months following randomisation

Description: Number of deaths (from death registry) associated with a positive SARS-CoV-2 test

Measure: Mortality with SARS-CoV-2

Time: Measured over the 12 months following randomisation

Description: Number of participants with fever or respiratory illness will be defined as: fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)

Measure: Fever or respiratory illness

Time: Measured over the 12 months following randomisation

Description: Number of episodes of fever or respiratory illness, defined as fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)

Measure: Episodes of fever or respiratory illness

Time: Measured over the 12 months following randomisation

Description: Number of days (using self-reported questionnaire) unable to work (excludes quarantine/workplace restrictions) due to fever or respiratory illness defined as fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)

Measure: Work absenteeism due to fever or respiratory illness

Time: Measured over the 12 months following randomisation

Description: Number of days confined to bed (using self-reported questionnaire) due to fever or respiratory illness defined as fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)

Measure: Bed confinement due to fever or respiratory illness

Time: Measured over the 12 months following randomisation

Description: Number of days with symptoms in any episode of illness that meets the case definition for fever or respiratory illness: fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)

Measure: Symptom duration of fever or respiratory illness

Time: Measured over the 12 months following randomisation

Description: Number of pneumonia cases (abnormal chest X-ray) (using self-reported questionnaire and/or medical/hospital records)

Measure: Pneumonia

Time: Measured over the 12 months following randomisation

Description: Need for oxygen therapy (using self-reported questionnaire and/or medical/hospital records)

Measure: Oxygen therapy

Time: Measured over the 12 months following randomisation

Description: Number of admission to critical care (using self-reported questionnaire and/or medical/hospital records)

Measure: Critical care admissions

Time: Measured over the 12 months following randomisation

Description: Number of participants needing mechanical ventilation (using self-reported questionnaire and/or medical/hospital records)

Measure: Mechanical ventilation

Time: Measured over the 12 months following randomisation

Description: Number of deaths (from death registry)

Measure: Mortality

Time: Measured over the 12 months following randomisation

Description: Number of days of hospitalisation due to fever or respiratory illness (using self-reported questionnaire, medical/hospital records and/or government registries)

Measure: Hospitalisation duration with fever or respiratory illness

Time: Measured over the 12 months following randomisation

Description: Number of days of unplanned absenteeism for any reason (using self-reported questionnaire)

Measure: Unplanned work absenteeism

Time: Measured over the 12 months following randomisation

Description: Cost of hospitalisation due to COVID-19 will be reported and compared between groups (using hospital administrative linked costing records held by individual hospitals and state government routine costing data collections to provide an estimate of the cost to hospitals for each episode of COVID-19 care)

Measure: Hospitalisation cost to treat COVID-19

Time: Measured over the 12 months following randomisation

Description: Type and severity of local and systemic adverse events will be collected in self-reported questionnaire and graded using toxicity grading scale.

Measure: Local and systemic adverse events to BCG vaccination in healthcare workers

Time: Measured over the 3 months following randomisation

140 Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial

Coronavirus disease 2019 (COVID-19) was recognized as a pandemic on March 11, 2020 by the World Health Organization. The virus that causes COVID-19 (SARS-CoV-2) is easily transmitted through person to person and there is still no specific approach against the disease and mortality rate in severe cases is also significant. Therefore, finding effective treatment for the mortality of these patients is very important. In this study the investigators aim to determine the effect of Convalescent Plasma on COVID-19 patients Outcome through a Clinical Trial

NCT04327349 Coronavirus Infections Biological: Convalescent Plasma

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.

Measure: Mortality changes in day 10

Time: 10 days after plasma transmission

Description: Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.

Measure: Mortality changes in day 30

Time: 30 days after plasma transmission

Description: Measurement of CRP

Measure: Changes of C-reactive protein

Time: Day 1

Description: Measurement of CRP

Measure: Changes of C-reactive protein

Time: Day 3

Description: Measurement of CRP

Measure: Changes of C-reactive protein

Time: Day 7

Description: Measurement of IL-6

Measure: Changes of Interleukin 6

Time: Day 1

Description: Measurement of IL-6

Measure: Changes of Interleukin 6

Time: Day 3

Description: Measurement of IL-6

Measure: Changes of Interleukin 6

Time: Day 7

Description: Measurement of TNF-α

Measure: Changes of tumor necrosis factor-α

Time: Day 1

Description: Measurement of TNF-α

Measure: Changes of tumor necrosis factor-α

Time: Day 3

Description: Measurement of TNF-α

Measure: Changes of tumor necrosis factor-α

Time: Day 7

Description: Partial pressure of arterial oxygen/Percentage of inspired oxygen

Measure: Changes of PaO2/FiO2 Ratio

Time: Day 1

Description: Partial pressure of arterial oxygen/Percentage of inspired oxygen

Measure: Changes of PaO2/FiO2 Ratio

Time: Day 3

Description: Partial pressure of arterial oxygen/Percentage of inspired oxygen

Measure: Changes of PaO2/FiO2 Ratio

Time: Day 7

Secondary Outcomes

Measure: Changes of CD3

Time: Day 1

Measure: Changes of CD3

Time: Day 3

Measure: Changes of CD3

Time: Day 7

Measure: Changes of CD4

Time: Day 1

Measure: Changes of CD4

Time: Day 3

Measure: Changes of CD4

Time: Day 7

Measure: Changes of CD8

Time: Day 1

Measure: Changes of CD8

Time: Day 3

Measure: Changes of CD8

Time: Day 7

Measure: Changes of CD4/CD8 ratio

Time: Day 1

Measure: Changes of CD4/CD8 ratio

Time: Day 3

Measure: Changes of CD4/CD8 ratio

Time: Day 7

Measure: Changes of lymphocyte count

Time: Day 1

Measure: Changes of lymphocyte count

Time: Day 3

Measure: Changes of lymphocyte count

Time: Day 7

Measure: Changes of leukocyte count

Time: Day 1

Measure: Changes of leukocyte count

Time: Day 3

Measure: Changes of leukocyte count

Time: Day 7

Measure: Changes of alanine transaminase (ALT)

Time: Day 1

Measure: Changes of alanine transaminase (ALT)

Time: Day 3

Measure: Changes of alanine transaminase (ALT)

Time: Day 7

Measure: Changes of aspartate transaminase (AST)

Time: Day 1

Measure: Changes of aspartate transaminase (AST)

Time: Day 3

Measure: Changes of aspartate transaminase (AST)

Time: Day 7

Measure: Changes of alkaline phosphatase (ALP)

Time: Day 1

Measure: Changes of alkaline phosphatase (ALP)

Time: Day 3

Measure: Changes of alkaline phosphatase (ALP)

Time: Day 7

Measure: Changes of lactate dehydrogenase (LDH)

Time: Day 1

Measure: Changes of lactate dehydrogenase (LDH)

Time: Day 3

Measure: Changes of lactate dehydrogenase (LDH)

Time: Day 7

Measure: Changes of creatine phosphokinase (CPK)

Time: Day 1

Measure: Changes of creatine phosphokinase (CPK)

Time: Day 3

Measure: Changes of creatine phosphokinase (CPK)

Time: Day 7

Measure: Changes of Creatine kinase-MB (CK-MB)

Time: Day 1

Measure: Changes of Creatine kinase-MB (CK-MB)

Time: Day 3

Measure: Changes of Creatine kinase-MB (CK-MB)

Time: Day 7

Measure: Changes of Specific IgG

Time: Day 1

Measure: Changes of Specific IgG

Time: Day 3

Measure: Changes of Specific IgG

Time: Day 7

Description: Computed tomography Scan and Chest X-Ray

Measure: Radiological findings

Time: Within 2 hours after admission

Description: Computed tomography Scan and Chest X-Ray

Measure: Radiological findings

Time: Day 14

Measure: Number of days ventilated

Time: Through study completion, an average of 2 weeks

Measure: Length of hospitalization

Time: Through study completion, an average of 2 weeks

141 An Adaptive Phase 3, Randomized, Double-blind, Placebo-controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID19

Primary Objective: To evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with severe or critical COVID-19 Secondary Objectives: - Evaluate the 28-day survival rate - Evaluate the clinical efficacy of sarilumab compared to the control arm by clinical severity - Evaluate changes in the National Early Warning Score 2 (NEWS2) - Evaluate the duration of predefined symptoms and signs (if applicable) - Evaluate the duration of supplemental oxygen dependency (if applicable) - Evaluate the incidence of new mechanical ventilation use during the study - Evaluate the duration of new mechanical ventilation use during the Study - Evaluate the proportion of patients requiring rescue medication during the 28-day period - Evaluate need for admission into intensive care unit (ICU) - Evaluate duration of hospitalization (days) - The secondary safety objectives of the study are to evaluate the safety of sarilumab through hospitalization (up to day 29 if patient is still hospitalized) compared to the control arm as assessed by incidence of: - Serious adverse events (SAEs) - Major or opportunistic bacterial or fungal infections in patients with grade 4 neutropenia - Grade ≥2 infusion related reactions - Grade ≥2 hypersensitivity reactions - Increase in alanine transaminase (ALT) ≥3X upper limit of normal (ULN) (for patients with normal baseline) or >3X ULN AND at least 2-fold increase from baseline value (for patients with abnormal baseline) - Major or opportunistic bacterial or fungal infections

NCT04327388 Corona Virus Infection Drug: Sarilumab SAR153191 Drug: Placebo

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The ordinal scale is an assessment of the clinical status. Score ranges 1-7. Lower score is worse.

Measure: Time to improvement of 2 points in clinical status assessment from baseline using the 7-point ordinal scale

Time: Baseline to Day 29

Secondary Outcomes

Measure: Percent of patients alive at Day 29

Time: Day 29

Description: The ordinal scale is an assessment of the clinical status. Score ranges 1-7. Lower score is worse.

Measure: Proportion of patients with one point improvement from baseline in clinical status assessment at days 4, 7, 15, 21, 29 using the 7-point ordinal scale

Time: Baseline to Days 4, 7, 15, 21, 29

Description: The ordinal scale is an assessment of the clinical status. Score ranges 1-7. Lower score is worse.

Measure: Mean change in the 7-point ordinal scale from baseline to Days 4, 7, 15, 21, and 29 (or until discharge)

Time: Baseline to Days 4, 7, 15, 21, 29 (or until discharge)

Description: Defined as body temperature (≤36.6°C [axilla], or ≤37.2 °C [oral], or ≤37.8°C [rectal or tympanic]) for at least 48 hours without antipyretics or until discharge, whichever is sooner.

Measure: Time to resolution of fever

Time: Baseline to Day 29

Description: Resolution of both fever and improvement in oxygenation. Resolution of fever is defined as body temperature (≤36.6°C [axilla], or ≤37.2 °C [oral], or ≤37.8°C [rectal or tympanic]) for at least 48 hours without antipyretics or until discharge, whichever is sooner. Improvement in oxygenation is defined as SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2 for at least 48 hours, or until discharge, whichever is sooner.

Measure: Time to resolution of fever and improvement in oxygenation

Time: Baseline to Day 29

Description: Fever is defined as >37.4°C (axilla), or >38.0 °C (oral), or >38.4°C (rectal or tympanic) based on maximum value observed during a 24-hour period.

Measure: Days with fever

Time: Baseline to Day 29

Description: The National Early Warning Score (NEWS2) is used to standardize the assessment of acute-illness severity, track the clinical condition of patients, and to alert clinical teams to patient deterioration. Score ranges from 0-20. A higher score is worse.

Measure: Time to change in NEWS2 from baseline

Time: Baseline to Day 29

Description: The NEWS2 is used to standardize the assessment of acute-illness severity, track the clinical condition of patients, and to alert clinical teams to patient deterioration. Score ranges from 0-20. A higher score is worse.

Measure: Time to NEWS2 of <2 and maintained for 24 hours

Time: Baseline to Day 29

Measure: Mean change from baseline to days 4, 7, 15, 21, and 29 in NEWS2

Time: Baseline to days 4, 7, 15, 21, and 29

Description: SpO2/FiO2 of 50 or greater compared to the nadir for at least 48 hours, or until discharge, whichever is sooner. SpO2 is oxygen saturation and FiO2 is the fraction of inspired oxygen.

Measure: Time-to-improvement in oxygenation

Time: Baseline to Day 29

Description: Supplemental oxygen is defined as oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device.

Measure: Alive off supplemental oxygen at day 29

Time: Day 29

Description: Hypoxemia is defined as SpO2 <93% on room air, or requiring supplemental oxygen, or mechanical ventilatory support.

Measure: Days of hypoxemia

Time: Baseline to Day 29

Description: Supplemental oxygen is defined as oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device.

Measure: Days of supplemental oxygen use

Time: Baseline to Day 29

Measure: Days of resting respiratory rate >24 breaths/min

Time: Baseline to Day 29

Measure: Time to saturation ≥94% on room air

Time: Baseline to Day 29

Measure: Ventilator free days in the first 28 days (to day 29)

Time: Baseline to Day 29

Description: For those not requiring these interventions at baseline.

Measure: The number of patients with Initiation of mechanical ventilation, non-invasive ventilation, or use of high flow nasal cannula

Time: Baseline to Day 60

Measure: Proportion of patients requiring rescue medication during the 28-day period

Time: Baseline to Day 28

Description: For patients are not in ICU at baseline

Measure: The number of patients transferred to the ICU or the need to transfer to the ICU (if the ICU is not available)

Time: Baseline to Day 60

Measure: Days of hospitalization among survivors

Time: Baseline to Day 60

Measure: Incidence of serious adverse events

Time: Baseline to Day 60

Measure: The incidence of major or opportunistic bacterial or fungal infections

Time: Baseline to Day 60

Measure: The incidence of major or opportunistic bacterial or fungal infections in patients with grade 4 neutropenia

Time: Baseline to Day 60

Measure: The incidence of hypersensitivity reactions, infusion reactions, gastrointestinal perforation

Time: Baseline to Day 60

Measure: The number of patients with clinically significant laboratory abnormalities

Time: Baseline to Day 60

142 COVID-19-associated ARDS Treated With DEXamethasone: an Open-label, Randomized, Controlled Trial: CoDEX (Alliance Covid-19 Brasil III)

The Severe Acute Respiratory Syndrome COronaVirus 2 (SARS-CoV2) is a new and recognized infectious disease of the respiratory tract. Most cases are mild or asymptomatic. However, around 5% of all patients develop Acute Respiratory Distress Syndrome (ARDS), which is the leading mortality cause in these patients. Corticosteroids have been tested in deferent scenarios of ARDS, including viral pneumonia, and the early use of dexamethasone is safe and appears to reduce the duration of mechanical ventilation in ARDS patients. Nevertheless, no large, randomized, controlled trial was performed evaluating the role of corticosteroids in patients with ARDS due SARS-CoV2 virus. Therefore, the present study will evaluate the effectiveness of dexamethasone compared to control (no corticosteroids) in patients with moderate and severe ARDS due to SARS-CoV2 virus.

NCT04327401 Coronavirus Infection Pneumonia, Viral Acute Respiratory Distress Syndrome Drug: Dexamethasone

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: Ventilator-free days, defined as alive and free from mechanical ventilation, at 28 days after randomization.

Measure: Ventilator-free days

Time: 28 days after randomization

Secondary Outcomes

Description: Evaluation of the clinical status of patients on the 15th day after randomization defined by the 6-point Ordinal Scale, this scale ranges from 1 (Not hospitalized) to 6 (Death) with higher scores meaning worse outcomes.

Measure: Evaluation of the clinical status

Time: 15 days after randomization

Description: All-cause mortality rates at 28 days after randomization.

Measure: All-cause mortality

Time: 28 days after randomization

Description: Number of days of mechanical ventilation from randomization to day 28.

Measure: Mechanical ventilation duration

Time: 28 days after randomization

Description: Sequential Organ Failure Assessment (SOFA) Score 48 hours, 72 hours and 7 days after randomization

Measure: Sequential Organ Failure Assessment (SOFA) Score

Time: Score at 48 hours, 72 hours and 7 days after randomization

Other Outcomes

Description: Intensive Care Unit free days, defined as alive and discharged from the intensive care unit, at 28 days after randomization.

Measure: Intensive Care Unit free days

Time: 28 days after randomization

143 A Randomized, Controlled, Open Label, Multicentre Clinical Trial to Explore Safety and Efficacy of Hyperbaric Oxygen for Preventing ICU Admission, Morbidity and Mortality in Adult Patients With COVID-19

COVID-19 may cause severe pneumonitis that require ventilatory support in some patients, the ICU mortality is as high as 62%. Hospitals do not have enough ICU beds to handle the demand and to date there is no effective cure. We explore a treatment administered in a randomized clinical trial that could prevent ICU admission and reduce mortality. The overall hypothesis to be evaluated is that HBO reduce mortality, increase hypoxia tolerance and prevent organ failure in patients with COVID19 pneumonitis by attenuating the inflammatory response.

NCT04327505 SARS (Severe Acute Respiratory Syndrome) Cytokine Storm ARDS, Human COVID-19 Sars-CoV2 Acute Respiratory Failure Drug: Hyperbaric oxygen

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Respiratory Insufficiency Respiratory Distress Syndrome, Adult

Primary Outcomes

Description: The proportion of subjects admitted to ICU from day 1 to day 30, based on at least one of the following criteria: i) Rapid progression over hours ii) Lack of improvement on high flow oxygen >40L/min or non invasive ventilation with fraction of inspired oxygen (FiO2) > 0.6 iii) Evolving Hypercapnia or increased work of breathing not responding to increased oxygen despite maximum standard of care available outside ICU iv) Hemodynamic instability or multi organ failure with maximum standard of care available outside ICU

Measure: ICU admission

Time: Through study completion 30 days

Secondary Outcomes

Description: Proportion of subjects with 30-day mortality, all cause Mortality, from day 1 to day 30.

Measure: 30-day mortality

Time: Through study completion 30 days

Description: Time-to-Intubation, i.e. cumulative days free of invasive mechanical ventilation, from day 1 to day 30

Measure: Time-to-intubation

Time: Through study completion 30 days

Description: Time-to-ICU, i.e. cumulative ICU free days, derived as the number of days from day 1 to ICU, where all ICU free subjects are censored at day 30.

Measure: Time-to-ICU

Time: Through study completion 30 days

Description: Mean change in inflammatory response from day 1 to day 30. White cell count + differentiation Procalcitonin C-Reactive protein Cytokines (IL-6) (if available at local laboratory) Ferritin D-Dimer LDH

Measure: Inflammatory response

Time: Through study completion 30 days

Description: Overall survival (Kaplan-Meier)

Measure: Overall survival

Time: Through study completion 30 days

Other Outcomes

Description: Hospital mortality of any cause, proportion of subjects, from day 1 to day 30.

Measure: Hospital mortality

Time: Through study completion 30 days

Description: Proportion of subjects with ICU mortality, Mortality of any cause in ICU, from day 1 to day 30.

Measure: ICU mortality

Time: From ICU admission to study completion 30 days

Description: Time-to-stop of intubation/invasive mechanical ventilation, from ICU admission to day 30.

Measure: Time in Invasive Ventilation

Time: From ICU admission to study completion 30 days

Description: Mean daily NEWS from day 1 to day 30.

Measure: NEWS

Time: Through study completion 30 days

Description: Mean change in PaO2/FiO2 (PFI), from day 1 to day 2, … to day 30.

Measure: PaO2/FiO2 (PFI)

Time: Through study completion 30 days

Description: Proportion of HBO treatments given vs planned. Proportion of subjects with HBO treatment administered within 24h after enrolment.

Measure: HBO Compliance

Time: Day 1 to day 7

Description: Time-to-discharge from hospital

Measure: Hospital discharge

Time: Through study completion 30 days

Description: Mean oxygen dose per day including HBO and cumulative pulmonary oxygen toxicity expressed as Units of oxygen pulmonary toxicity dose (UPTD) and Cumulative pulmonary toxicity dose (CPTD) from day 1 to day 30.

Measure: Oxygen dose

Time: Through study completion 30 days

Description: Median number of HBO treatments and dose of HBO given, from day 1 to day 7

Measure: HBO dose

Time: Day 1 to day 7

Description: Change in expression of Micro RNA in plasma from day 1 to day 30

Measure: Micro RNA

Time: Through study completion 30 days

Description: Change in gene expression and Micro RNA interactions in Peripheral Blood Mononuclear Cells (PBMC) (20 Subjects) from day 1 to day 30

Measure: Hypoxic response

Time: Through study completion 30 days

Description: Immunological response (20 subjects) from day 1 to day 30 in the following. Cytokines extended including (IL-1β, IL-2, IL-6, IL33 and TNFα) Lymphocyte profile Flowcytometry with identification of monocyte/lymphocyte subsets including but not limited to CD3+/CD4+/CD8+ and CD4+/CD8+ ratio FITMaN panel/Flow cytometry, Interleukins (IL-1β, IL-2, IL-6, IL33 and TNFα), T-reg cells (CD3+/CD4+/CD25+/CD127+) Monocyte proliferation markers, Ex vivo monocyte function

Measure: Immunological response

Time: Through study completion 30 days

Description: Mean change in routine biomarkers for organ dysfunction, from day 1to day 30.

Measure: Multi organ dysfunction

Time: Through study completion 30 days

Description: Viral load, review of records from day 1 to day 30.

Measure: Viral load

Time: Through study completion 30 days

Description: Number of secondary infections, review of records, number of events and patients from day 1 to day 30.

Measure: Secondary infections

Time: Through study completion 30 days

Description: Diagnosed PE needing treatment, review of records, number of events and patients from day 1 to day 30.

Measure: Pulmonary embolism

Time: Through study completion 30 days

Description: Changes on Pulmonary CT, review of records from day 1 to day 30.

Measure: Pulmonary CT

Time: Through study completion 30 days

Description: Changes on Chest X-ray, review of records from day 1 to day 30.

Measure: Chest X-ray

Time: Through study completion 30 days

Description: Changes in Lung ultrasound, review of records from day 1 to day 30.

Measure: Lung ultrasound

Time: Through study completion 30 days

144 In-depth Characterisation of the Dynamic Host Immune Response to Coronavirus SARS-CoV-2

The COntAGIouS trial (COvid-19 Advanced Genetic and Immunologic Sampling; an in-depth characterization of the dynamic host immune response to coronavirus SARS-CoV-2) proposes a transdisciplinary approach to identify host factors resulting in hyper-susceptibility to SARS-CoV-2 infection, which is urgently needed for directed medical interventions.

NCT04327570 Coronavirus Infections Other: Patient sampling

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Description of clinical, laboratory and radiological features of illness and complications.

Measure: Clinical Features

Time: 6 months

Description: Evaluation of dynamic host immune response at systemic level (immune signalling molecules in plasma, peripheral blood mononuclear cell isolation for advanced immunophenotyping and transcriptomics). Real-time analysis using CyTOF will be performed as screening, in combination with in-depth immunophenotyping.

Measure: Immune host response at systemic level

Time: 6 months

Measure: Immune host response at local level

Time: 6 months

Description: Identification of host genetic variants that are associated with severity of disease.

Measure: Host genetic variation

Time: 6 months

Secondary Outcomes

Description: Differences in baseline factors

Measure: Comparison severe and non-severe COVID-19 hospitalised patients

Time: 6 months

Description: Differences in immune characteristics

Measure: Comparison severe and non-severe COVID-19 hospitalised patients

Time: 6 months

Description: Correlation of findings with outcome, aiming to identify early biomarkers of severe disease and putative targets for immunomodulatory therapy

Measure: Correlation of findings with outcome

Time: 6 months

Description: Correlation of immune profiling with microbiome analysis of patients

Measure: Correlation of immune profiling - microbiome

Time: 6 months

145 A Longitudinal Study of COVID-19 Positive Patients Testing Nasal Swabs and Collecting Blood Samples for Research

Minimal risk research study: 1. Comparing polyester nasal swabs and foam nasal swabs to detect SARS-CoV-2 virus; 2. Quantifying the development and trajectory of the disease through clinic visits and blood values.

NCT04327804 SARS-CoV Infection Diagnostic Test: Odd/Even birth year intervention groups

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Measure the agreement between the detection of SARS-CoV-2 virus using a foam nasal swab tested directly after collection, a polyester nasal swab tested directly after testing, and a polyester nasal swab stored at room temperature for four days without saline or VTM before being tested.

Measure: Detection of SARS-CoV-2 virus

Time: 42 days

Secondary Outcomes

Description: Longitudinal blood samples from SARS-CoV-2 patients to gain a better understanding of the trajectory of COVID-19 and antibody development

Measure: Trajectory of COVID-19 and antibody development

Time: 2 months

146 Household Transmission Investigation Study for Coronavirus Disease 2019 (COVID-19) in French Guiana

This study is a interventional study that present minimal risks and constraints to evaluate the presence of novel coronavirus (SARS-CoV-2) or antibodies among individuals living in households where there is a confirmed coronavirus case in order to provide useful information on the proportion of symptomatic forms and the extent of the virus transmission in a territory such as French Guiana.

NCT04328129 Coronavirus Infections Severe Acute Respiratory Syndrome SARS-CoV Infection Procedure: Human biological samples

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The extent of the virus transmission within households will be assessed by evaluating the rate of intra-household secondary transmission of the virus

Measure: Evaluation of the extent of the virus transmission within households

Time: 2 years

Secondary Outcomes

Description: The characterization of the secondary cases will be assessed by evaluating the proportion of asymptomatic forms within the household

Measure: Characterization of the secondary cases

Time: 2 years

Description: The characterization of the secondary cases will be assessed by characterizing the risk factors for coronavirus infection.

Measure: Characterization of the secondary cases

Time: 2 years

147 Clinical Characteristics and Prognostic Factors of Patients With COVID-19 in Chibi Hospital of Hubei Province

NCT04328454 Cor Coronavirus Other: retrospective analysis

MeSH:Coronavirus Infections

Primary Outcomes

Description: The primary outcome is the time to negative conversion of coronavirus

Measure: Time to negative conversion of severe acute respiratory syndrome coronavirus 2

Time: 1 month

Secondary Outcomes

Description: The time of hospitalization

Measure: Length of stay in hospital

Time: 1 month

Description: The rate of survival within hospitalization of these patients will be tracked. The rate of survival within hospitalization of these patients will be tracked. The rate of survival within hospitalization of these patients will be tracked. The rate of survival within hospitalization of these patients will be tracked.

Measure: Survival

Time: 1 month

Description: The rate of intubation within hospitalization of these patients will be tracked

Measure: Intubation

Time: 1 month

148 Pre-exposure Prophylaxis for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial

Objective: To determine if pre-exposure prophylaxis with hydroxychloroquine is effective for the prevention of COVID-19 disease.

NCT04328467 COVID-19 Corona Virus Infection ARDS Acute Respiratory Distress Syndrome Drug: Hydroxychloroquine Other: Placebo

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: Outcome reported as the percent of participants in each arm who are COVID-19-free at the end of study treatment.

Measure: COVID-19-free survival

Time: up to 12 weeks

Secondary Outcomes

Description: Outcome reported as the percent of participants in each arm who have a confirmed SARS-CoV-2 infection during study treatment.

Measure: Incidence of confirmed SARS-CoV-2 detection

Time: up to 12 weeks

Description: Outcome reported as the percent of participants in each arm who report COVID-19-related symptoms during study treatment.

Measure: Incidence of possible COVID-19 symptoms

Time: up to 12 weeks

Description: Outcome reported as the percent of participants in each arm who discontinue study medication use for any reason during treatment.

Measure: Incidence of all-cause study medicine discontinuation

Time: up to 12 weeks

Description: Participants will self-report COVID-19 status on an ordinal scale as follows: No illness (score=1), Illness with outpatient observation (score=2), Hospitalization (or post-hospital discharge) (score=3), or Hospitalization with ICU stay or death (score=4). Possible scores range from 1-4 with higher scores indicating greater disease severity.

Measure: Ordinal Scale of COVID-19 Disease maximum severity if COVID-19 diagnosed at study end

Time: up to 12 weeks

Description: Outcome reported as the percent of participants in each arm who are hospitalized or expire due to COVID-19 during study treatment.

Measure: Incidence of Hospitalization for COVID-19 or death

Time: up to 12 weeks

Description: Outcome reported as the percent of participants in each arm who experience medication-related side effects during study treatment.

Measure: Incidence of study medication-related side effects

Time: up to 12 weeks

149 Efficacy of Hydroxychloroquine for Post-exposure Prophylaxis (PEP) to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection Among Adults Exposed to Coronavirus Disease (COVID-19): a Blinded, Randomized Study

This is a clinical study for the prevention of SARS-CoV-2 infection in adults exposed to the virus. This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age (inclusive) who are close contacts of persons with laboratory confirmed SARS-CoV-2 or clinically suspected COVID-19. Eligible participants will be enrolled and randomized to receive the intervention or placebo at the level of the household (all eligible participants in one household will receive the same intervention).

NCT04328961 COVID-19 Corona Virus Infection SARS (Severe Acute Respiratory Syndrome) SARS-CoV-2 Drug: Hydroxychloroquine Sulfate Drug: Ascorbic Acid

MeSH:Infection Severe Acute Respiratory Syndrome Coronavirus Infections Syndrome

Primary Outcomes

Description: Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected daily for 14 days

Measure: Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection

Time: Day 1 through Day 14 after enrolment

Description: Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected at study exit

Measure: Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection

Time: Day 28 after enrolment

Secondary Outcomes

Description: Safety and tolerability of Hydroxychloroquine as SARS-CoV-2 PEP in adults

Measure: Rate of participant-reported adverse events

Time: 28 days from start of Hydroxychloroquine therapy

Description: PCR-confirmed COVID-19 diagnosis

Measure: Incidence rates of COVID-19 through study completion

Time: 28 days from enrolment

150 The CORONAvirus Disease 2019 Angiotensin Converting Enzyme Inhibitor/Angiotensin Receptor Blocker InvestigatiON (CORONACION) Randomized Clinical Trial

Coronavirus disease 2019 (COVID-19) is a pandemic infection caused by a virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Because SARS-CoV-2 is known to require the angiotensin-converting enzyme 2 (ACE-2) receptor for uptake into the human body, there have been questions about whether medications that upregulate ACE-2 receptors might increase the risk of infection and subsequent complications. One such group of medications are anti-hypertensives that block the renin-angiotensin system, including both angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARB). Both ACEi and ARB are widely used for the treatment of hypertension. Early reports from China and Italy suggest that many of those who die from COVID-19 have a coexisting history of hypertension. Consequently, there have been questions raised as to whether these 2 types of blood pressure medication might increase the risk of death among patients with COVID-19. However, it is well known that the prevalence of hypertension increases linearly with age. Therefore, it is possible that the high prevalence of hypertension and ACEi/ARB use among persons who die from COVID-19 is simply confounded by age (older people are at risk of both a history of hypertension and dying from COVID-19). Whether these commonly prescribed blood pressure medications increase the risk of COVID-19 or not remains unanswered. Statements from professional cardiology societies on both sides of the Atlantic have called for urgent research into this question. Our study aims to randomize patients with primary (essential) hypertension who are already taking ACEi/ARB to either switch to an alternative BP medication or continue with the ACEi/ARB that they have already been prescribed. Adults with compelling indications for ACEi/ARB will not be enrolled.

NCT04330300 Hypertension COVID-19 Drug: Thiazide or Thiazide-like diuretics Drug: Calcium Channel Blockers Drug: ACE inhibitor Drug: Angiotensin receptor blocker

MeSH:Coronavirus Infections Hypertension

HPO:Hypertension

Primary Outcomes

Description: Time from randomization to the first occurrence of any of the clinical events above

Measure: Number of Covid-19 positive participants who die, require intubation in ICU, or require hospitalization for non-invasive ventilation (NIV)

Time: 12 months

Secondary Outcomes

Description: Time from randomization to the first occurrence of above

Measure: Number of Covid-19 positive participants who die

Time: 12 months

Description: Time from randomization to the first occurrence of above

Measure: Number of Covid-19 positive participants who require intubation in intensive care unit (ICU)

Time: 12 months

Description: Time from randomization to the first occurrence of above

Measure: Number of Covid-19 positive participants who require hospitalization for non-invasive ventilation (NIV)

Time: 12 months

Description: Time from randomization to the first occurrence of above

Measure: Number of SARS-CoV-2 positive participants

Time: 12 months

Measure: Maximum troponin T value (ng/L) among Covid-19 positive participants who require acute hospitalization

Time: 12 months

Description: Performed in a random sub-sample of the cohort (both study arms)

Measure: 24 hour mean systolic BP (mmHg) on ambulatory BP monitoring

Time: 12 months

Description: Time from randomization to the first occurrence of above

Measure: All-cause mortality

Time: 12 months

151 Impact of the Coronavirus (COVID-19) on Patients With Cancer

The purpose of this study is to understand the impact of COVID-19 on patients with cancer through a survey.

NCT04330521 Cancer COVID-19

MeSH:Coronavirus Infections

Primary Outcomes

Description: We will track the number of participants who fill out the survey for the 12 month duration of the study and the number of participants who participate in the semi-structured telephone interviews.

Measure: Number of participants who fill out the survey and participate in the semi-structured interviews.

Time: 12 Months

152 Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Tocilizumab Trial - CORIMUNO-19 - TOCI (CORIMUNO-TOCI)

The overall objective of the study is to determine the therapeutic effect and tolerance of Tocizilumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding sIL-6R and mIL-6R. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Tocilizumab administration to patients enrolled in the COVIMUNO-19 cohort. Tocilizumab will be administered to consenting adult patients hospitalized with CORVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Tocilizumab will receive standard of cares. Outcomes of Tocilizumab-treated patients will be compared with outcomes of standard of care treated patients as well as outcomes of patients treated with other immune modulators.

NCT04331808 Corona Virus Infection Drug: Tocilizumab

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Group 1. Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Thus, events considered are needing ventilator utilization (including Non Invasive Ventilation, NIV or high flow), or death. New DNR order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.

Measure: Survival without needs of ventilator utilization at day 14. Group 1

Time: 14 days

Description: Group 1. Proportion of patients alive without non-invasive ventilation of high low at day 4 (WHO progression scale ≤ 5). A patient with new DNR order at day 4 will be considered as with a score > 5. WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10

Measure: WHO progression scale <=5 at day 4. Group 1.

Time: 4 days

Description: Group 2. Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 if patients have been intubated before day 14 ; or removal of NIV or high flow (for > 48h) if they were included under oxygen by NIV or High flow (score 6) and remained without intubation. Death or new DNR order (if given after the inclusion of the patient) will be considered as a competing event.

Measure: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14. Group 2.

Time: 14 days

Description: Group 2 Early end point : proportion of patients with a decrease of WHO score of at least 1 point at day 4. WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10

Measure: WHO progression scale at day 4. Group 2.

Time: 4 days

Secondary Outcomes

Measure: WHO progression scale

Time: 7 and 14 days

Description: Overall survival

Measure: Survival

Time: 14, 28 and 90 days

Measure: 28-day ventilator free-days

Time: 28 days

Description: arterial blood pH of <7.25 with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours

Measure: respiratory acidosis at day 4

Time: 4 days

Description: evolution of PaO2/FiO2 ratio

Measure: PaO2/FiO2 ratio

Time: day 1 to day 14

Description: time to oxygen supply independency

Measure: time to oxygen supply independency

Time: 14 days

Description: duration of hospitalization

Measure: duration of hospitalization

Time: 90 days

Description: time to negative viral excretion

Measure: time to negative viral excretion

Time: 90 days

Description: time to ICU discharge

Measure: time to ICU discharge

Time: 90 days

Description: time to hospital discharge

Measure: time to hospital discharge

Time: 90 days

153 An Observational Study of Patients With Coronavirus Disease 2019

This is an observational study of patients with COVID-19 designed to specifically address important clinical questions that remain incompletely answered for coronavirus disease 2019.

NCT04331886 COVID-19 Coronavirus

MeSH:Coronavirus Infections

Primary Outcomes

Measure: Natural history of COVID-19: Characteristics of COVID-19

Time: 12 months

Measure: Natural history of COVID-19: Participant demographics

Time: 12 months

Measure: Natural history of COVID-19: Treatment use

Time: 12 months

Measure: Time point of clinical response

Time: 12 months

154 Convalescent Plasma for Patients With COVID-19: A Pilot Study

Convalescent plasma (CP) has been used in recent years as an empirical treatment strategy when there is no vaccine or treatment available for infectious diseases. In the latest viral epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization issued a document outlining a protocol for the use of whole blood or plasma collected from patients who have recovered from the Ebola virus disease by transfusion to empirically treat local infectious outbreaks.

NCT04332380 Coronavirus Coronavirus Infection Drug: Plasma

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Copies of COVID-19 per ml

Measure: Change in Viral Load

Time: Days 0, 4, 7, 14 and 28

Description: Immunoglobulin M COVID-19 antibodies

Measure: Change in Immunoglobulin M COVID-19 antibodies Titers

Time: Days 0, 4, 7, 14 and 28

Description: Immunoglobulin G COVID-19 antibodies

Measure: Change in Immunoglobulin G COVID-19 antibodies Titers

Time: Days 0, 4, 7, 14 and 28

Secondary Outcomes

Description: Proportion of patients with Intensive Care Unit Admission requirement (days 7, 14 and 28)

Measure: Intensive Care Unit Admission

Time: Days 7, 14 and 28

Description: Days of Intensive Care Unit management (days 7, 14 and 28)

Measure: Length of Intensive Care Unit stay

Time: Days 7, 14 and 28

Description: Days of Hospitalization (days 7, 14 and 28)

Measure: Length of hospital stay (days)

Time: Days 7, 14 and 28

Description: Proportion of patients with mechanical ventilation (days 7, 14 and 28)

Measure: Requirement of mechanical ventilation

Time: Days 7, 14 and 28

Description: Days with mechanical ventilation (days 7, 14 and 28)

Measure: Duration (days) of mechanical ventilation

Time: Days 7, 14 and 28

Description: 1. Hospital discharge; 2. Hospitalization, not requiring supplemental oxygen; 3. Hospitalization, requiring supplemental oxygen (but not Noninvasive Ventilation/ HFNC); 4. Intensive care unit/hospitalization, requiring Noninvasive Ventilation/ HFNC therapy; 5. Intensive care unit, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 6. Death. (days 7, 14 and 28)

Measure: Clinical status assessed according to the World Health Organization guideline

Time: Days 7, 14 and 28

Description: Proportión of death patients at days 7, 14 and 28

Measure: Mortality

Time: Days 7, 14 and 28

155 Angiotensin-(1,7) Treatment in COVID-19: the ATCO Trial

Background: A novel Coronavirus (SARS-CoV-2) described in late 2019 in Wuhan, China, has led to a pandemic and to a specific coronavirus-related disease (COVID-19), which is mainly characterized by a respiratory involvement. While researching for a vaccine has been started, effective therapeutic solutions are urgently needed to face this threaten. The renin-angiotensin system (RAS) has a relevant role in COVID-19, as the virus will enter host 's cells via the angiotensin-converting enzyme 2 (ACE2); RAS disequilibrium might also play a key role in the modulation of the inflammatory response that characterizes the lung involvement. Angiotensin-(1-7) is a peptide that is downregulated in COVID-19 patient and it may potentially improve respiratory function in this setting. Methods/Design: The Investigators describe herein the methodology of a randomized, controlled, adaptive Phase II/Phase III trial to test the safety, efficacy and clinical impact of the infusion of angiotensin-(1-7) in COVID-19 patients with respiratory failure requiring mechanical ventilation. A first phase of the study, including a limited number of patients (n=20), will serve to confirm the safety of the study drug, by observing the number of the severe adverse events. In a second phase, the enrollment will continue to investigate the primary endpoint of the study (i.e. number of days where the patient is alive and not on mechanical ventilation up to day 28) to evaluate the efficacy and the clinical impact of this drug. Secondary outcomes will include the hospital length of stay, ICU length of stay, ICU and hospital mortality, time to weaning from mechanical ventilation, reintubation rate, secondary infections, needs for vasopressors, PaO2/FiO2 changes, incidence of deep vein thrombosis, changes in inflammatory markers, angiotensins plasmatic levels and changes in radiological findings. The estimated sample size to demonstrate a reduction in the primary outcome from a median of 14 to 11 days is 56 patients, 60 including a dropout rate of 3% (i.e. 30 per group), but a preplanned recalculation of the study sample size is previewed after the enrollment of 30 patients. Expected outcomes/Discussion: This controlled trial will assess the efficacy, safety and clinical impact of the Angiotensin-(1-7) infusion in a cohort of COVID-19 patients requiring mechanical ventilation. The results of this trial may provide useful information for the management of this disease.

NCT04332666 Coronavirus Respiratory Failure Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere SARS-CoV-2 Drug: Angiotensin 1-7 Drug: Placebos

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency

Primary Outcomes

Description: composite outcome of mortality and necessity of mechanical ventilation

Measure: ventilator free days

Time: 28 days

Secondary Outcomes

Description: number of days free from intensive care unit

Measure: ICU free days

Time: trough study completion, on average 40 days

Description: Hospital length of stay

Measure: Hospital length of stay

Time: through study completion, on average 60 days

Description: Time to wean from mechanical ventilation

Measure: Time to wean from mechanical ventilation

Time: through study completion, on average 14 days

Description: PaO2/FiO2 changes during drug administration

Measure: PaO2/FiO2 changes during drug administration

Time: 48 hours

Description: US confirmed deep vein thrombosis

Measure: Deep vein thrombosis incidence

Time: through study completion, on average 30 days

Description: including IL-1, IL-2, IL-6, IL-7, IL-8, IL-10, TNF-alpha, interferon gamma

Measure: Changes in inflammatory markers

Time: at randomization, 48 hours after randomization and 72 hours after randomization

Description: Ang II and Ang-(1-7) plasmatic levels

Measure: RAS effectors levels

Time: at randomization, 48 hours after randomization and 72 hours after randomization

Description: Chest x-ray or CT scan changes

Measure: Radiological findings

Time: through study completion, on average 30 days

Other Outcomes

Description: phase 2b = principal safety outcome; phase 3 = secondary outcome

Measure: Rate of serious adverse events

Time: study drug administration/day 28 or ICU discharge or death

156 Convalescent Plasma for Patients With COVID-19: A Randomized, Open Label, Parallel, Controlled Clinical Study

NCT04332835 Coronavirus Coronavirus Infection Drug: Plasma Drug: Hydroxychloroquine

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Copies of COVID-19 per ml

Measure: Change in Viral Load

Time: Days 0, 4, 7, 14 and 28

Description: Immunoglobulin M COVID-19 antibodies

Measure: Change in Immunoglobulin M COVID-19 Titers

Time: Days 0, 4, 7, 14 and 28

Description: Immunoglobulin G COVID-19 antibodies

Measure: Change in Immunoglobulin G COVID-19 Titers

Time: Days 0, 4, 7, 14 and 28

Secondary Outcomes

Description: Proportion of patients with Intensive Care Unit Admission requirement (days 7, 14 and 28)

Measure: Intensive Care Unit Admission

Time: Days 7, 14 and 28

Description: Days of Intensive Care Unit management (days 7, 14 and 28)

Measure: Length of Intensive Care Unit stay

Time: Days 7, 14 and 28

Description: Days of Hospitalization (days 7, 14 and 28)

Measure: Length of hospital stay (days)

Time: Days 7, 14 and 28

Description: Proportion of patients with mechanical ventilation (days 7, 14 and 28)

Measure: Requirement of mechanical ventilation

Time: Days 7, 14 and 28

Description: Days with mechanical ventilation (days 7, 14 and 28)

Measure: Duration (days) of mechanical ventilation

Time: Days 7, 14 and 28

Measure: Clinical status assessed according to the World Health Organization guideline

Time: Days 7, 14 and 28

Description: Proportion of death patients at days 7, 14 and 28

Measure: Mortality

Time: Days 7, 14 and 28

157 Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease

ORCHID is a multicenter, blinded, placebo-controlled, randomized clinical trial evaluating hydroxychloroquine for the treatment of adults hospitalized with COVID-19. Patients, treating clinicians, and study personnel will all be blinded to study group assignment.

NCT04332991 Coronavirus Acute Respiratory Infection SARS-CoV Infection Drug: Hydroxychloroquine Drug: Placebo

MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome

HPO:Respiratory tract infection

Primary Outcomes

Description: We will determine the COVID Ordinal Scale for all patients on study day 15 COVID Ordinal Scale defined as: Death Hospitalized on invasive mechanical ventilation or ECMO ( extracorporeal membrane oxygenation) Hospitalized on non-invasive ventilation or high flow nasal cannula Hospitalized on supplemental oxygen Hospitalized not on supplemental oxygen Not hospitalized with limitation in activity (continued symptoms) Not hospitalized without limitation in activity (no symptoms)

Measure: COVID Ordinal Outcomes Scale on Day 15

Time: assessed on study day 15

Secondary Outcomes

Description: Vital status of the patient on day 15 will be determined using any of the following methods: medical record review, phone calls to patient or proxy

Measure: all-location, all-cause mortality assessed on day 15

Time: assessed on study day 15

Description: Vital status of the patient at day 28 will be determined using any of the following methods: medical record review, phone calls to patient or proxy

Measure: all-location, all-cause mortality assessed on day 29

Time: assessed on study day 29

Description: We will determine the COVID Ordinal Scale for all patients on study day 3

Measure: COVID Ordinal Outcomes Scale on Study Day 3

Time: assessed on study day 3

Description: We will determine the COVID Ordinal Scale on study day 8

Measure: COVID Ordinal Outcomes Scale on Study Day 8

Time: assessed on study day 8

Description: We will determine the COVID Ordinal Scale on study day 29

Measure: COVID Ordinal Outcomes Scale on Study Day 29

Time: assessed on study day 29

Description: We will determine the number of patients who are either dead or on ECMO ( extracorporeal membrane oxygenation) between enrollment and day 28

Measure: Number of patients dead or with receipt of ECMO between enrollment and Day 28

Time: Enrollment to Day 28

Description: The number of calendar days between randomization and 28 days later that the patient is alive and without the use of oxygen therapy. Patients who die prior to day 28 are assigned zero oxygen free days.

Measure: Oxygen-free days through Day 28

Time: 28 days after randomization

Description: Ventilator-free days is defined to be 28 days minus the duration of mechanical ventilation through day 28. Participants who do not survive to day 28 are assigned zero ventilator-free days.

Measure: Ventilator-free days through Day 28

Time: 28 days after randomization

Description: The number of calendar days between randomization and 28 days later that the patient is alive and without the use of vasopressor therapy. Patients who die prior to day 28 are assigned zero vasopressor free days.

Measure: Vasopressor-free days through Day 28

Time: 28 days after randomization

Description: The number of days spent out of the ICU to day 28.

Measure: ICU-free days to Day 28

Time: 28 days after randomization

Description: Defined as 28 days minus the number of days from randomization to discharge home.If a patient has not been discharged home prior to day 28 or dies prior to day 28, hospital free days will be zero.

Measure: Hospital-free days to Day 28

Time: 28 days after randomization

Other Outcomes

Description: We will determine the number of patients that experience seizure between randomization and day 28

Measure: Number of patients with seizures to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience ventricular arrhythmia between randomization and day 28

Measure: Number of patients with atrial or ventricular arrhythmia to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience cardiac arrest between randomization and day 28

Measure: Number of patients with cardiac arrest to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience elevation in aspartate aminotransferase or alanine aminotransferase to twice the local upper limit of normal between randomization and day 28

Measure: Number of patients with elevation in aspartate aminotransferase or alanine aminotransferase to twice the local upper limit of normal to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience acute pancreatitis between randomization and day 28

Measure: Number of patients with acute pancreatitis arrest to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience acute kidney injury between randomization and day 28

Measure: Number of patients with acute kidney injury to day28

Time: 28 days after randomization

Description: We will determine the number of patients that experience renal replacement therapy between randomization and day 28

Measure: Number of patients with receipt of renal replacement therapy to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience symptomatic hypoglycemia between randomization and day 28

Measure: Number of patients with symptomatic hypoglycemia to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience neutropenia, lymphopenia, anemia, or thrombocytopenia between randomization and day 28

Measure: Number of patients with neutropenia, lymphopenia, anemia, or thrombocytopenia to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience severe dermatologic reaction between randomization and day 28

Measure: Number of patients with severe dermatologic reaction to day 28

Time: 28 days after randomization

Description: Time to recovery, defined as time to reaching level 5, 6, or 7 on the COVID Outcomes Scale, which is the time to the earlier of final liberation from supplemental oxygen or hospital discharge

Measure: Time to recovery, defined as time to reaching level 5, 6, or 7 on the COVID Outcomes Scale, which is the time to the earlier of final liberation from supplemental oxygen or hospital discharge

Time: 28 days after randomization

158 Cell Therapy Using Umbilical Cord-derived Mesenchymal Stromal Cells in SARS-CoV-2-related ARDS

Whereas the pandemic due do Covid-19 continues to spread, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes Severe Acute Respiratory Distress Syndrome in 30% of patients with a 30%-60% mortality rate for those requiring hospitalization in an intensive care unit. The main physio-pathological hallmark is an acute pulmonary inflammation. Currently, there is no treatment. Mesenchymal stem cells (MSC) feature several attractive characteristics: ease of procurement, high proliferation potential, capacity to home to inflammatory sites, anti-inflammatory, anti-fibrotic and immunomodulatory properties. If all MSC share several characteristics regardless of the tissue source, the highest productions of bioactive molecules and the strongest immunomodulatory properties are yielded by those from the Wharton's jelly of the umbilical cord. An additional advantage is that they can be scaled-up to generate banks of cryofrozen and thus readily available products. These cells have already been tested in several clinical trials with an excellent safety record. The objective of this project is to treat intubated-ventilated patients presenting with a SARS-CoV2-related Acute Respiratory Distress Syndrome (ARDS) of less than 96 hours by three intravenous infusions of umbilical cord Wharton's jelly-derived mesenchymal stromal cells (UC-MSC) one every other day (duration of the treatment: one week). The primary endpoint is the PaO2/FiO2 ratio at day 7. The evolution of several inflammatory markers, T regulatory lymphocytes and donor-specific antibodies will also be monitored. The trial will include 40 patients, of whom 20 will be cell-treated while the remaining 20 patients will be injected with a placebo solution in addition to the standard of care. Given the pathophysiology of SARS-CoV2, it is thus sound to hypothesize that the intravenous administration of UC-MSC during the initial phase of ARDS could control inflammation, accelerate its recovery with improved oxygenation, reduced mechanical ventilation and ventilation weaning time and therefore reduced length of stay in intensive care. The feasibility of the project is supported by the expertise of the Meary Cell and Gene Therapy Center, which is approved for the production of Advanced Therapy Medicinal Products and has already successfully prepared the first batches of cells, as well as by the involvement of a cardiac surgery team which will leverage its experience with stem cells for the treatment of heart failure to make it relevant to the Stroma-Cov-2 project.

NCT04333368 Severe Acute Respiratory Syndrome Coronavirus 2 Severe Acute Respiratory Distress Syndrome Biological: Umbilical cord Wharton's jelly-derived human Other: NaCl 0.9%

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Measure: Respiratory efficacy evaluated by the increase in PaO2/FiO2 ratio from baseline to day 7 in the experimental group compared with the placebo group

Time: From baseline to day 7

Secondary Outcomes

Measure: Lung injury score

Time: From baseline to day 28

Measure: Oxygenation index

Time: From baseline to day 28

Measure: In-hospital mortality

Time: From baseline to day 28

Measure: Mortality

Time: At day 28

Measure: Ventilator-free days

Time: From baseline to day 28

Measure: Number of days between randomization and the first day the patient meets weaning criteria o Number of days between randomization and the first day the patient meets PaO2/FiO2 > 200 (out of a prone positioning session)

Time: From baseline to day 28

Measure: Cumulative use of sedatives

Time: From baseline to day 28

Measure: Cumulative duration of use of sedatives

Time: From baseline to day 28

Measure: Cumulative duration of use of neuromuscular blocking agents (other than used for intubation)

Time: From baseline to day 28

Measure: Cumulative use of neuromuscular blocking agents (other than used for intubation)

Time: From baseline to day 28

Measure: ICU-acquired weakness and delirium

Time: From baseline to day 28

Measure: Treatment-induced toxicity rate and adverse events up to day 28

Time: From baseline to day 28

Measure: Quality of life at one year (EQ5D-3L quality of life questionnaire)

Time: At 6 months and 12 months

Measure: Measurements of plasmatic cytokines (IL1, IL6, IL8, TNF-alpha, IL10, TGF-beta, sRAGE, Ang2) level

Time: At day 1, 3, 5, 7 and 14

Measure: Anti-HLA antibodies plasmatic dosage

Time: From baseline to day 14, and at 6 months

159 Piclidenoson for Treatment of COVID-19 - A Randomized, Double-Blind, Placebo-Controlled Trial

Patients with documented moderate COVID-19 infection will be randomized 1:1 to receive piclidenoson 2 mg Q12H orally with standard supportive care (SSC - intervention arm) or placebo orally with SSC (control arm) for up to 28 days.

NCT04333472 COVID-19 Coronavirus Infection Drug: Piclidenoson Drug: Placebo

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Proportion of subjects alive and free of respiratory failure (defined as need for non-invasive or invasive mechanical ventilation, high-flow oxygen, or extracorporeal membrane oxygenation) at Day 29

Measure: Proportion of subjects alive and free of respiratory failure

Time: 29 days

Description: Proportion of subjects alive and discharged to home without need for supplemental oxygen at Day 29

Measure: Proportion of subjects discharged home alive

Time: 29 days

Description: Proportion of patients experiencing AEs

Measure: Treatment-emergent adverse events (AEs)

Time: 29 days

Secondary Outcomes

Description: Clinical status at Day 29 on a 7-point ordinal scale, where 1 = not hospitalized with resumption of normal activities; 2 = not hospitalized but unable to resume normal activities; 3 = hospitalized but not requiring supplemental oxygen; 4 = hospitalized and requiring supplemental oxygen; 5 = hospitalized and requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation; 6 = hospitalized and requiring invasive mechanical ventilation and/or extra-corporeal membrane oxygenation; and 7 = death

Measure: Clinical status

Time: 29 days

Description: Time (days) to improvement of 2 points on 7-point ordinal clinical scale

Measure: Time to improvement

Time: 29 days

Description: Proportion of patients who require mechanical ventilation

Measure: Incidence of mechanical ventilation

Time: 29 days

Description: Ventilator-free days to Day 29

Measure: Ventilator-free days

Time: 29 days

Description: Proportion of patients who require ICU admission

Measure: Incidence of Intensive Care Unit (ICU) admission

Time: 29 days

Description: Duration (days) of ICU stay

Measure: Duration of ICU stay

Time: 29 days

Description: Time (days) to hospital discharge

Measure: Time to hospital discharge

Time: 29 days

Description: Duration (days) of need for supplemental oxygen

Measure: Duration of need for supplemental oxygen

Time: 29 days

Description: Time (days) to virus negativity by RT-PCR, defined as absence of SARS CoV 2 on 2 consecutive days of sampling

Measure: Time to virus negativity

Time: 29 days

Description: SARS-CoV-2 viral load (number of copies) by quantitative RT-PCR

Measure: SARS-CoV-2 viral load

Time: 29 days

Description: Proportion of patients experiencing AEs leading to early discontinuation of trial treatment

Measure: AEs leading to withdrawal

Time: 29 days

Description: Proportion of patients experiencing SAEs

Measure: Treatment-emergent serious AEs (SAEs)

Time: 29 days

Description: Proportion of patients experiencing treatment-emergent changes in clinical laboratory parameters or ECGs

Measure: Treatment-emergent abnormalities in clinical laboratory parameters or electrocardiograms (ECGs)

Time: 29 days

Description: Proportion of patients who meet study safety-related stopping rules

Measure: Incidence of meeting safety-related stopping rules

Time: 29 days

Description: Plasma concentrations over time of piclidenoson

Measure: Pharmacokinetics of piclidenoson in this patient population

Time: 5 days

160 The Mechanism, Clinical Outcome and Therapeutic Intervention of Corona Virus Disease 2019 Patients Whose Nucleic Acids Changed From Negative to Positive

To investigate the mechanism, clinical outcome and therapeutic efficacy with favipiravir of Corona Virus Disease 2019 patients whose nucleic acids changed from negative to positive.

NCT04333589 COVID-19 Drug: Favipiravir

MeSH:Coronavirus Infections Virus Diseases

Primary Outcomes

Description: Proportion of subjects who tested negative for nucleic acid from sputum or nasopharyngeal swabs for two consecutive times(sampling time at least 24 hours).

Measure: Viral nucleic acid test negative conversion rate

Time: 5 months

Secondary Outcomes

Measure: Clinical cure rate

Time: 5 months

161 A Phase 1b, Randomized, Double-blinded, Placebo-controlled Study of Hydroxychloroquine in Outpatient Adults With COVID-19

Primary Objective: To assess the effect of hydroxychloroquine versus placebo on nasopharyngeal SARS-CoV-2 viral load in outpatient adults with COVID-19 Secondary Objectives: - To assess the effect of hydroxychloroquine versus placebo on clinical signs and symptoms and progression of disease in outpatient adults with COVID-19 - To assess the safety and tolerability of hydroxychloroquine in outpatient adults with COVID-19

NCT04333654 Coronavirus Infection Drug: Hydroxychloroquine SAR321068 Drug: Placebo

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Viral load assessed by PCR from a nasopharyngeal swab

Measure: Change from baseline to Day 3 in nasopharyngeal SARS-CoV-2 viral load (if quantitative PCR is available)

Time: Baseline to Day 3

Description: Viral load assessed by PCR from a nasopharyngeal swab - 2. Viral load assessed by PCR from a nasopharyngeal swab

Measure: Number of participants by PCR result status (positive or negative) (if quantitative PCR is not available)

Time: Baseline to Day 3

Secondary Outcomes

Description: Viral load assessed by PCR from a nasopharyngeal swab

Measure: Change from baseline to Day 5 in nasopharyngeal SARS-CoV-2 viral load

Time: Baseline to Day 5

Description: Viral load assessed by PCR from a nasopharyngeal swab

Measure: Number of participants by PCR result status (positive or negative)

Time: Baseline to end of study (Day14)

Measure: Number of participants with COVID-19 symptoms by severity

Time: Baseline to end of study (Day14)

Description: COVID-19 symptoms (feverishness, sore throat, cough, shortness of breath, myalgias) will be scored by the participant on a 4-point scale ( 0 =none; 1 = mild; 2 = moderate; 3 = severe). Resolution of a symptom is defined as when a symptom previously scored ≥ 1 on the scale is scored as 0

Measure: Time to resolution of COVID-19 Symptoms

Time: Baseline to end of study (Day14)

Description: Resolution of fever defined as the first day of 2 consecutive daily temperatures < 37.7 C

Measure: Time to resolution of fever

Time: Baseline to end of study (Day14)

Description: Resolution of fever defined as the first day of 2 consecutive daily temperatures < 37.7 C

Measure: Percentage of participants with resolution of fever

Time: Baseline to end of study (Day14)

Measure: Percentage of participants hospitalized

Time: Baseline to end of study (Day14)

Measure: Number of participants with Adverse Events

Time: Baseline to end of study (Day14)

162 Telephony Or Videophony for Isolated elDerly in Maine-Et-Loire 49 During COVID-19

The current health crisis at COVID-19 is forcing us to profoundly rethink our social organizations, especially towards our most fragile seniors. Prohibitions on visits to Nursing Homes and care services, although essential to control the epidemic, are also becoming a major source of social isolation and loneliness for these fragile populations. The only source of residual social ties during a period of confinement remains dematerialised communication via the various existing communication channels (in particular telephone calls or video telephony). As soon as the COVID-19 crisis began and the first visiting restrictions were imposed on patients in the geriatric department of the Angers Univesity Hospital and the Retirement Home / long-term care unit, acute care geriatric unit of Angers offered patients and residents the opportunity to organize communication with their relatives via videophone calls. Initial feedback from the field shows us that, contrary to our intuition, patients and residents are not necessarily asking for communication to the outside world and, when they are, the preferred channel is not necessarily video telephony but often a simple phone call with relatives. Even though the vast majority of projects aimed at setting up communication aids for the elderly now rely on videophonic support, these initial observations in everyday care situations raise questions about the directions taken in this area. Also, the investigators ask themselves the following question: in the absence of a physical meeting, what is the preferred means of communication for elderly people in isolation in hospital or in Retirement Home? This study will make it possible to propose the most appropriate solutions for breaking isolation for the hospitalized or institutionalized geriatric population in order to limit as much as possible the increase in social isolation imposed by restrictions on movement during epidemics.

NCT04333849 Coronavirus

MeSH:Coronavirus Infections

Primary Outcomes

Description: Choice between videophony, telephony or neither.

Measure: Preferred means of communication for elderly people in isolation, hospitalized in the acute care geriatric unit or residing at St Nicolas nursing home (Angers UH).

Time: at baseline (day 0)

Secondary Outcomes

Description: Aid received or not (by a caregiver) in connecting with the relative.

Measure: proportion of elderly people with loss of functional independence to communicate with their relatives.

Time: at baseline (day 0)

Description: The satisfaction will be assessed using a non-validated satisfaction questionnaire based on a forced choice Likert scale in 6 points from 1 to 6. Patients will be considered as satisfied if the mean score is over 4 on 6.

Measure: level of satisfaction of patients who have benefited from a telephone call.

Time: at baseline (day 0)

Measure: level of satisfaction of patients who have benefited from a videophone call.

Time: at baseline (day 0)

Description: The satisfaction averages of the two groups wishing to use a means of communication (telephony or videophony) will be compared by a Student t-test.

Measure: satisfaction level of older people according to the means of communication used.

Time: at baseline (day 0)

Measure: impact of age on the preferred means of communication.

Time: at baseline (day 0)

163 Treatment of Severe Acute Respiratory Syndrome Caused by COVID-19 With Ruxolitinib

In December 2019, a new virus emerged in Wuhan, China rapidly becoming a pandemic with registered cases above 800,000 around the world. The virus is now known as SARS-CoV2 calling its disease coronavirus-19 or COVID-19. The mortality of the virus has been reported around 2-10% and its causes because of the proinflammatory immune response generated on the host. The cytokines involved in the immune response to COVID-19 are IL-1, IL-2, IL4, IL-6, IL-10, IL-12, IL-13, IL-17, GCSF, MCSF, IP-10, MCP-1, MIP-1α, HGF, IFN-γ y TNF-α. Ruxolitinib is an inhibitor of JAK 1/2 which is responsable for multiple cellular signals including the proinflammatory IL-6. Ruxolitinib works as and immunomodulator decreasing the cytotoxic T lymphocytes and increasing the Treg cells. This study is intended to stop the disregulated immune response caused by COVID-19 that generates the pneumonia and subsequent severe acute respiratory syndrome.

NCT04334044 COVID-19 Severe Acute Respiratory Syndrome Coronavirus 2 Drug: Ruxolitinib Oral Tablet

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Syndrome

Primary Outcomes

Description: Presence of recovery of pneumonia characterized by cease of respiratory symptoms

Measure: Recovery of Pneumonia

Time: 14 days

Secondary Outcomes

Description: Increment or decrease in mg/ml of C-reactive protein

Measure: Response of C-reactive protein

Time: 14 days

Description: Increment or decrease in ng/ml of ferritin

Measure: Response of Ferritin

Time: 14 days

Description: Increment or decrease in mg/ml of D-dimer

Measure: Response of D-dimer

Time: 14 days

Description: Requirement of Intensive Care Unit on the patients under treatment

Measure: Rate of ICU admission

Time: 14 days

Description: Requirement of mechanical ventilation on the patients under treatment

Measure: Rate of mechanical ventilation

Time: 14 days

Description: Time since the diagnosis to the last follow up (recovery or death)

Measure: Overall Survival

Time: 1 month

Description: Rate of adverse events associated with ruxolitinib

Measure: Toxicity Rate

Time: 1 month

164 Efficacy and Safety of Anluohuaxian in the Treatment of Rehabilitation Patients With Corona Virus Disease 2019-A Multicenter, Open, Randomized Controlled Study

To evaluate the efficacy and safety of Anluohuaxian in blocking the progression of pulmonary fibrosis and improving lung function in patients with COVID-19.

NCT04334265 COVID-19 Drug: Anluohuaxian

MeSH:Coronavirus Infections Virus Diseases

Primary Outcomes

Description: Changes in ground-glass shadows, interstitial or air nodules found on high-resolution computer tomography

Measure: Changes in high-resolution computer tomography of the lung

Time: 3 months

Measure: Change in 6-minute walking distance

Time: 3 months

Secondary Outcomes

Measure: Changes in compound physiological index

Time: 3 months

Description: St. George's Hospital Respiratory Questionnaire range from 0 to 100. 0 stands for no impact on life and 100 stands for extreme impact on life.

Measure: Changes in the scores of the St. George's Hospital Respiratory Questionnaire

Time: 3 months

Description: mMRC score range from 0 to 4. 0 stands for wheezing only when exercising hard and 4 stands for severe breathing difficulties.

Measure: Changes in modified British Medical Research Council Dyspnea Scale (mMRC) scores

Time: 3 months

Description: Adult male vital capacity is about 3,500 ml and female is about 2,500 ml.

Measure: Changes in vital capacity of the lung

Time: 3 months

165 Investigation Of The Effectiveness Of The Telerehabilitation Applied To Individuals Over The Age Of 65 Who Experience Social Isolation At Houses Due To The Coronavirus (Covid-19) Pandemic

In December 2019, new coronavirus pneumonia (COVID-19) erupted in Wuhan (Hubei, China) and quickly spread from a single city to the entire country in just 30 days and then attracted worldwide attention. COVID-19 causes a large number of deaths due to its occurrence in many cases. This virus caused a total of 549,461 approved cases and 24,887 deaths worldwide. All the countries of the world take some precautions to prevent the spread of this epidemic disease, which WHO declared it as "pandemic". Staying home and social isolation are at the top of these precautions. For this purpose, in Turkey on March 21, 2020, '65 and older individuals began to apply the curfew to individuals with chronic illnesses. However, not leaving the house and social isolation brings with it the limitation of physical activity. Physical activity (PA) is defined by WHO as any bodily movement produced by the contraction of skeletal muscles that increases energy consumption. Recommended PA levels for the elderly (≥65 years) are similar to adults (18 to 64 years old). At the global level, approximately 45% of people over the age of 60 do not meet the recommended level of PA. Studies investigating the relationship between social isolation and health behavior report consistent findings. Individuals with smaller social networks report less healthy diets, excessive alcohol consumption, and less physical activity. The effects of social isolation are related to physical inactivity, smoking and the possibility of having both health risk behaviors together. The decrease in physical performance is associated with the risk of falling, sarcopenia, fragility, decreased quality of life, emotionalization, comorbidity, early death, and increased health care costs. Practical and innovative interventions are needed to reduce the decline in muscle mass, strength and physical performance in the aging population. When today's conditions are evaluated, technology-supported education programs are effective in increasing the motivation for physical activity. The purpose of this study; to evaluate the physical activity level of individuals over the age of 65 who experience social isolation due to the precautions taken in our country to prevent the spread of the COVID-19 pandemic, and to investigate the effectiveness of home-based telerehabilitation exercises. It is aimed to use an innovative model based on the digitally supported, home-based exercise program.

NCT04334434 Telerehabilitation Other: Telerehabilitation

MeSH:Coronavirus Infections

Primary Outcomes

Description: One of the evaluation parameters created to evaluate the physical activity level of elderly individuals, the factors affecting the activity level, the relationship between physical activity and health profile is the Physical Activity Scale for the Elderly. The minimum score that can be obtained from the scale is 0 and the maximum score is 400. The higher score on the scale indicates a better level of physical activity.

Measure: Physical Activity Scale for the Elderly

Time: 2 weeks

Description: Nottingham Health Profile was created in England in 1985 to evaluate the quality of life-related to health. The Nottingham Health Profile is a general quality of life questionnaire that assesses the level of individuals health problems and how they affect their daily life activities.

Measure: Nottingham Health Profile

Time: 2 weeks

Description: It was created by Gierveld and Kamphuis in 1985 to evaluate the sense of loneliness in older individuals and was revised in 1999 by Tilburg and Gierveld. It consists of 11 items in total and two subtitles.

Measure: Loneliness Scale for the Elderly

Time: 2 weeks.

166 A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Quintuple Therapy to Treat COVID-19 Infection

This is a Phase II interventional study will test the efficacy of quintuple therapy (Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc) in the treatment of patients with COVID-19 infection).

NCT04334512 COVID-19 Corona Virus Infection Coronavirus-19 Sars-CoV2 Drug: Hydroxychloroquine Drug: Azithromycin Dietary Supplement: Vitamin C Dietary Supplement: Vitamin D Dietary Supplement: Zinc

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of days from COVID-19 diagnosis to recovery via RT-PCR

Measure: The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy

Time: 12 weeks

Description: Reduction and/or progression of symptomatic days, reduction of symptom severity

Measure: Reduction or Progression of Symptomatic Days

Time: 12 weeks

Description: Assess the symptom response to study therapy as measured by the survey in the EDC

Measure: Assess the safety of Quintuple Therapy

Time: 12 weeks

Description: Pulse from baseline to 12 weeks

Measure: Assess the safety of Quintuple Therapy via pulse

Time: 12 weeks

Description: Oxygen saturation from baseline to 12 weeks

Measure: Assess the safety of Quintuple Therapy via oxygen saturation

Time: 12 weeks

Description: EKG response from baseline to 12 weeks

Measure: Assess the safety of Quintuple Therapy via EKG

Time: 12 weeks

Description: Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy

Measure: Assess Tolerability of Quintuple Therapy

Time: 12 weeks

167 Lipid Ibuprofen Versus Standard of Care for Acute Hypoxemic Respiratory Failure Due to COVID-19: a Multicentre, Randomised, Controlled Trial

The study aims to evaluate the reduction in severity and progression of lung injury with three doses of lipid ibuprofen in patients with SARS-CoV-2 infections.

NCT04334629 Coronavirus Respiratory Distress Syndrome SARS-CoV Infection Drug: Ibuprofen

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult

Primary Outcomes

Description: Worsening respiratory failure; defined using severity of hypoxaemia using [PaO2/FiO2 ratio OR SpO2/FiO2 ratio]

Measure: Disease progression

Time: 14 days

Description: Time to mechanical ventilation (or need of)

Measure: Time to mechanical ventilation

Time: 14 days

Secondary Outcomes

Measure: Overall survival

Time: 28 days

Measure: Reduction in proportion of patients who require ventilation

Time: 28 days

Measure: Reduction in length of Critical Care stay

Time: 28 days

Measure: Reduction in length of Hospital stay

Time: 28 days

Measure: Modulation of serum pro- and anti-inflammatory cytokines

Time: 28 days

Measure: Reduction in duration of ventilation

Time: 28 days

Measure: Increase in ventilator-free days

Time: 28 days

168 Prevention of SARS-CoV-2 (COVID-19) Through Pre-Exposure Prophylaxis With Tenofovir Disoproxil Fumarate/Emtricitabine and Hydroxychloroquine in Healthcare Personnel: Randomized Clinical Trial Controlled With Placebo

Healthcare workers are particularly at risk of SARS-CoV-2. This study aims to assess the efficacy of a daily single dose of tenofovir disoproxil fumarate (TDF) (245 mg)/ Emtricitabine (FTC) (200 mg), a daily single dose of hydroxychloroquine (HC) (200 mg), a daily single dose of TDF (245 mg)/FTC (200 mg) plus HC (200 mg) versus placebo, during 12 weeks in: (1) reducing the incidence of symptomatic disease and (2) reducing clinical severity COVID-19 among hospital healthcare workers aged 18 to 70 years in public and private hospitals in Spain.

NCT04334928 Coronavirus Infection Drug: Emtricitabine/tenofovir disoproxil Drug: Hydroxychloroquine Drug: Placebo: Emtricitabine/tenofovir disoproxil Placebo Drug: Placebo: Hydroxychloroquine

MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Number of confirmed symptomatic infections of SARS-CoV-2 (COVID-19)

Time: 12 weeks

Secondary Outcomes

Description: assessed by: No symptoms Mild symptoms: general malaise, fever, cough, myalgia, asthenia. Moderate symptoms: mild symptoms plus shortness of breath, Severe symptoms: mild symptoms plus respiratory insufficiency that requires admission in intensive care unit and mechanical ventilation

Measure: Severity of disease in confirmed infected participants of SARS-CoV-2 (COVID-19)

Time: 12 weeks

Measure: Duration of symptoms in confirmed infected participants of SARS-CoV-2 (COVID-19) measured in days

Time: 12 weeks

169 Randomized Study to Evaluate the Safety and Antiviral Efficacy of Hydroxychloroquine in Patients With Newly Diagnosed COVID-19 Compared to Standard of Care Treatment

This study will assess the efficacy of hydroxychloroquine in reducing the severity of symptoms in patients with COVID-19

NCT04334967 COVID-19 Corona Virus Infection SARS-CoV-2 2019-nCoV 2019 Novel Coronavirus Drug: Hydroxychloroquine Dietary Supplement: Vitamin C

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: This outcome will be assessed by comparing the percentages of enrolled patients that are hospitalized in the treatment and control arms.

Measure: Total Hospitalization

Time: 14 days

Description: This outcome will be assessed by comparing the percentages of enrolled patients that have received mechanical ventilation in the treatment and control arms.

Measure: Total Mechanical Ventilation

Time: 14 days

Secondary Outcomes

Description: Self-reported body temperature. Each report scored low (less than 100.4), medium (100.4-102.2), or high (higher than 102.2). Outcome will be assessed by calculating percentage of patients with reported high, medium, low temperature at specified time points.

Measure: Fever intensity measure

Time: 2 days

Measure: Fever intensity measure

Time: 5 days

Measure: Fever intensity measure

Time: 10 days

Measure: Fever intensity measure

Time: 14 days

Description: Self-reported worsening shortness of breath. Each report scored yes/no. Outcome will be assessed by calculating percentage of patients with reported worsening of shortness of breath at specified time points.

Measure: Shortness of breath measure

Time: 2 days

Measure: Shortness of breath measure

Time: 5 days

Measure: Shortness of breath measure

Time: 10 days

Measure: Shortness of breath measure

Time: 14 days

Description: Self reported changes in daytime cough. Each report scored 0 (no cough), 1 (one short coughing attack), 2 (two or more short coughing attacks), 3 (frequent coughing that did not interfere with activities), 4 (frequent coughing that did interfere with activities, 5 (distressing cough throughout most of the day). Outcome will be measured by calculating change in reported cough at each time point.

Measure: Changes in daytime cough measure

Time: 2 days

Measure: Changes in daytime cough measure

Time: 5 days

Measure: Changes in daytime cough measure

Time: 10 days

Measure: Changes in daytime cough measure

Time: 14 days

Description: Self reported changes in nighttime cough. Each report scored 0 (no cough), 1 (cough on waking only), 2 (wake once or early due to cough), 3 (frequent waking due to cough), 4 (frequent coughing throughout the night, 5 (distressing cough preventing any sleep). Outcome will be measured by calculating change in reported cough at each time point.

Measure: Changes in nighttime cough measure

Time: 2 days

Measure: Changes in nighttime cough measure

Time: 5 days

Measure: Changes in nighttime cough measure

Time: 10 days

Measure: Changes in nighttime cough measure

Time: 14 days

Description: Number of enrolled patients who have died within the specified time frame

Measure: Total mortality

Time: 28 days

170 CORON-ACT - a Multicenter, Double-blind, Randomized Controlled Phase II Trial on the Efficacy and Safety of Tocilizumab in the Treatment of Coronavirus Induced Disease (COVID-19)

The mortality rate of the disease caused by the corona virus induced disease (COVID-19) has been estimated to be 3.7% (WHO), which is more than 10-fold higher than the mortality of influenza. Patients with certain risk factors seem to die by an overwhelming reaction of the immune system to the virus, causing a cytokine storm with features of Cytokine-Release Syndrome (CRS) and Macrophage Activation Syndrome (MAS) and resulting in Acute Respiratory Distress Syndrome (ARDS). Several pro-inflammatory cytokines are elevated in the plasma of patients and features of MAS in COVID-19, include elevated levels of ferritin, d-dimer, and low platelets. There is increasing data that cytokine-targeted biological therapies can improve outcomes in CRS or MAS and even in sepsis. Tocilizumab (TCZ), an anti-IL-6R biological therapy, has been approved for the treatment of CRS and is used in patients with MAS. Based on these data, it is hypothesized that TCZ can reduce mortality in patients with severe COVID-19 prone to CRS and ARDS. The overall purpose of this study is to evaluate whether treatment with TCZ reduces the severity and mortality in patients with COVID-19.

NCT04335071 SARS-CoV-2 Infection Drug: Tocilizumab (TCZ) Drug: Placebo

MeSH:Coronavirus Infections

Primary Outcomes

Measure: Number of patients with ICU admission

Time: 7 days after randomisation

Measure: Number of patients with intubation

Time: 14 days after randomisation

Measure: Number of patients with death

Time: 28 days after randomisation

Secondary Outcomes

Description: Assessed by the 8-point WHO scale

Measure: Illness severity

Time: At days 2, 7, 14, 28 after randomisation

Description: Clinical improvement is defined as a ≥ 2-point improvement in the 8-point WHO scale

Measure: Number of patients with clinical improvement

Time: At days 2, 7, 14, 28 after randomisation

Description: Clinical improvement is defined as a ≥ 2-point improvement in the 8-point WHO scale

Measure: Time to clinical improvement (days)

Time: Up to day 28 after randomisation

Measure: Duration of hospitalization (days)

Time: Up to day 28 after randomisation

Measure: Time to ICU admission (days)

Time: Up to day 28 after randomisation

Measure: Duration of ICU stay

Time: Up to day 28 after randomisation

Measure: Time to intubation

Time: Up to day 28 after randomisation

Measure: Duration of mechanical ventilation (days)

Time: Up to day 28 after randomisation

Other Outcomes

Measure: Number of deaths

Time: Within 28 days after randomisation

Measure: Number of patients with ICU admission

Time: Within 28 days after randomisation

Measure: Number of patients with intubation

Time: Within 28 days after randomisation

Description: Events of special interest are defined as secondary infections, acute kidney failure, hepatic, and cardiac failure

Measure: Number of patients with events of special interest

Time: Within 28 days after randomisation

Measure: Number of patients with SAEs considered by the investigator to be at least probably related to the IMP

Time: Within 28 days after randomisation

171 A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection

This is a Phase II interventional study testing whether treatment with hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19

NCT04335084 COVID-19 Coronavirus Infection Sars-CoV2 Corona Virus Infection COVID Coronavirus Coronavirus-19 Coronavirus 19 Drug: Hydroxychloroquine Dietary Supplement: Vitamin C Dietary Supplement: Vitamin D Dietary Supplement: Zinc

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Any symptoms of COVID-19 will be recorded in a daily diary. Symptoms (including fever measured in degrees Fahrenheit, dry cough, productive cough, difficulty speaking, wheezing, dry mouth, headache, chest tightness, difficulty with exertion, shortness of breath, sore throat, malaise, and diarrhea) will be rated as not present, mild, moderate, or severe.

Measure: Prevention of COVID-19 symptoms as recorded in a daily diary

Time: 24 weeks

Description: To assess the presence or absence of side effects (graded 1-5), and whether they are tolerable (grade 1-2). AE and SAE will be recorded.

Measure: Safety as determined by presence or absence of Adverse Events and Serious Adverse Events

Time: 24 weeks

172 PRAETORIAN-COVID: A Double-blind, Placebo-controlled Randomized Clinical Trial With Valsartan for PRevention of Acute rEspiraTORy dIstress Syndrome in hospitAlized patieNts With SARS-COV-2 (COVID-19) Infection Disease

Rationale: The current SARS-CoV-2 pandemic has a high burden of morbidity and mortality due to development of the so-called acute respiratory distress syndrome (ARDS). The renin-angiotensin-system (RAS) plays an important role in the development of ARDS. ACE2 is one of the enzymes involved in the RAS cascade. Virus spike protein binds to ACE2 to form a complex suitable for cellular internalization. The downregulation of ACE2 results in the excessive accumulation of angiotensin II, and it has been demonstrated that the stimulation of the angiotensin II type 1a receptor (AT1R) increases pulmonary vascular permeability, explaining the increased lung pathology when activity of ACE2 is decreased. Currently available AT1R blockers (ARBs) such as valsartan, have the potential to block this pathological process mediated by angiotensin II. There are presently two complementary mechanisms suggested: 1) ARBs block the excessive angiotensin-mediated AT1R activation, and 2) they upregulate ACE2, which reduces angiotensin II concentrations and increases the production of the protective vasodilator angiotensin 1-7. In light of the above, ARBs may prevent the development of ARDS and avert morbidity (admission to intensive care unit (ICU) and mechanical ventilation) and mortality. Objective: To investigate the effect of the ARB valsartan in comparison to placebo on the occurrence of one of the following items, within 14 days of randomization:1) ICU admission; 2) Mechanical ventilation; 3) Death. Study design: A double-blind, placebo-controlled 1:1 randomized clinical trial Study population: Adult hospitalized SARS-CoV-2-infected patients (n=651). Intervention: The active-treatment arm will receive valsartan in a dosage titrated to blood pressure up to a maximum of 160mg b.i.d. and the placebo arm will receive a matching placebo also titrated to blood pressure. Treatment duration will be 14 days or up to hospital discharge < 14 days or occurrence of the primary endpoint if < 14 days. Main study endpoint: The primary study endpoint is the occurrence within 14 days of randomization of either: 1) ICU admission; 2) Mechanical ventilation; 3) Death.

NCT04335786 Acute Respiratory Distress Syndrome SARS-CoV-2 COVID COVID-19 Severe Acute Respiratory Syndrome Drug: Valsartan (Diovan) Drug: Placebo oral tablet

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Description: Death is defined as all-cause mortality

Measure: first occurrence of intensive care unit admission, mechanical ventilation or death

Time: within 14 days

Secondary Outcomes

Description: All-cause mortality; and time to all-cause mortality

Measure: Death

Time: Within 14 days, 30 days, 90 days and at 1 year

Description: Occurrence of mechanical ventilation and time to ventilation

Measure: Mechanical ventilation

Time: within 14 days

Description: Occurrence of ICU admission and time to admission

Measure: Intensive care unit admission

Time: within 14 days

Description: Defined as a 50% decline in estimated glomerular filtration rate relative to baseline, or decrease of >30 ml/min/1.73m2 and to a value below 60 ml/min/1.73m2

Measure: Occurrence of acute kidney injury

Time: Within 14 days

173 Cohort Study of SARS-CoV-2 Incidence, Transmission, and Disease Severity in Healthcare Workers

The specific objective is to rapidly establish a prospective cohort to characterize the factors related to viral transmission and disease severity in a large healthcare system in healthcare settings and HCW (healthcare worker) households. Investigators propose to address this hypothesis by recruiting and longitudinally following 500 HCW and 250 age- and sex-matched NHCW (Non-healthcare workers) within a large academic health system, Rutgers Biomedical and Health Sciences (RBHS). By intensively following participants over a six-month period and collecting serial biospecimens (nasopharyngeal/throat swabs, blood, and saliva) and questionnaire data at nine time points, investigators can uniquely characterize Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) transmission and risk factors for Coronavirus Disease 19 (COVID-19) among health care workers and their families

NCT04336215 Coronavirus SARS-CoV-2 Other: Non-Interventional

MeSH:Coronavirus Infections

Primary Outcomes

Description: Prevalence and 95% confidence intervals, using standard epidemiological methods (Aims 1, 2, and 3).

Measure: Prevalence

Time: up to 24 weeks

Description: Incidence and 95% confidence intervals, using standard epidemiological methods (Aims 1, 2, and 3).

Measure: Incidence

Time: up to 24 weeks

174 Outcomes of Patients With COVID-19 in the Intensive Care Unit: A National Observational Study (Mexico COVID-19 ICU Study)

The objective of this study is to evaluate the clinical characteristics and outcomes of critically ill patients with COVID-19 admitted to the intensive care unit. A Multicenter Observational Study.

NCT04336345 Coronavirus Infections COVID-19 Viral Pneumonia Human Coronavirus

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: Mortality 30 days following hospital admission

Measure: Hospital mortality

Time: 30 days

Secondary Outcomes

Description: The number of calendar days from the day of admission (counted as 1 day) to day of intensive care unit discharge

Measure: Length of stay in the intensive care unit

Time: Through study completion, an average of 30 days

175 Phase 1 Open-label Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4800, a Prophylactic Vaccine Against SARS-CoV-2, Administered Intradermally Followed by Electroporation in Healthy Volunteers

This is an open-label trial to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device in healthy adult volunteers.

NCT04336410 Coronavirus Infection Drug: INO-4800 Device: CELLECTRA® 2000

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Percentage of Participants with Adverse Events (AEs)

Time: Baseline up to Week 52

Measure: Percentage of Participants with Administration (Injection) Site Reactions

Time: Day 0 up to Week 52

Measure: Percentage of Participants with Adverse Events of Special Interest (AESIs)

Time: Baseline up to Week 52

Measure: Change from Baseline in Antigen-Specific Binding Antibody Titers

Time: Baseline up to Week 52

Measure: Change from Baseline in Antigen-Specific Interferon-Gamma (IFN-γ) Cellular Immune Response

Time: Baseline up to Week 52

176 Determination Of Physical Activity, Sleep And Stress Level Of Pregnant Women In The Covıd-19 Quarantine Period

We hypothesized: During the COVID-19 pandemic, the sleep quality of pregnant women decreases. During the COVID-19 epidemic, the stress level of pregnant women increases. During the COVID-19 epidemic, the level of physical activity of pregnant women decreases. Aims: The aim of the study is to determine the sleep quality, stress level and physical activity level of pregnant women who maintain the home quarantine during the COVID-19 pandemic.

NCT04336787 Covid-19 Coronavirus Infection Pregnancy Related Other: Survey

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. Walking = 3.3 METs Moderate Intensity = 4.0 METs Vigorous Intensity = 8.0 METs Total MET-minutes/week = Walk (METs*min*days) + Mod (METs*min*days) + Vig (METs*min*days) 1. Low: • No activity is reported OR • Some activity is reported but not enough to meet Categories 2 or 3. 2. Moderate: • 3 or more days of vigorous activity of at least 20 minutes per day OR • 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day OR • 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-minutes/week. 3. High: • Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week

Measure: International Physical Activity Questionnaire

Time: Baseline of the study

Description: The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep. It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month.The client self rates each of these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5"or greater indicates a "poor" sleeper.

Measure: Pittsburgh Sleep Quality Index

Time: Baseline of the study

Description: The Perceived Stress Scale (PSS) is a 14-item self-report measure designed to assess "the degree to which situations in one's life are appraised as stressful. Each item is rated on a 5-point scale (0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Fairly Often, 4 = Very Often) and summed to create a total score. PSS-14 has strong internal consistency (α = .84 to .86) and good test-retest reliability (r = .85 over a 2-day period, r = .55 over a 6-week period.

Measure: Perceived Stress Scale

Time: Baseline of the study

Description: The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale rates the pain from 0 (no pain) to 10 (worst pain).

Measure: Numerical Pain Rating Scale

Time: Baseline of the study

177 Renin Angiotensin System - CoronaVirus

The aim of the study is to demonstrate overactivation of Renin Angiotensine System (RAS) in positives COVID-19 patient, especially in those with the most serious clinical forms where the mortality of patients in intensive care is on average 50%. We are expecting two groups: a group of 25 positive COVID 19 patients in intensive care and a group of 25 positive COVID 19 hospitalized patients in conventional hospitalisation. We will measure RAS, serum potassium and collect data on the treatment of these patients (especially antihypertensive therapy) one week apart (at the patient'entry into hospital and 7 days later). This is a preliminary study that could possibly allow the start of a therapeutic trial in order to test the effectiveness of RAS blocker treatments in this condition.

NCT04337008 COVID 19 Other: blood draw

MeSH:Coronavirus Infections

Primary Outcomes

Description: demonstrate overactivity of RAS in patients hospitalised in intensive car secondary to COVID-19 compared to control patients (COVID -19 hospitalised patients without complications ).

Measure: overactivity of the renin / aldosterone system

Time: 7 days

178 REmote MOniToring usE in Suspected Cases of COVID-19 (Coronavirus): REMOTE-COVID Trial

We are aiming to see if participant deterioration due to suspected coronavirus in a designated location (e.g. hotel) can be identified sooner by wearing the sensor. If we can identify sick participants early, participants are more likely to have better outcomes; we believe that the sensor can help us do this. The sensor measures heart rate, respiratory rate and temperature every 2 minutes and this can be reviewed by the clinical team looking after the participants.

NCT04337489 Coronavirus Device: SensiumVitals wearable sensor

MeSH:Coronavirus Infections

Primary Outcomes

Description: Detection of clinical deterioration using wearable sensors resulting in healthcare review (e.g. GP telephone consultation)

Measure: Deterioration resulting in healthcare review

Time: 1 year

Secondary Outcomes

Description: Deterioration resulting in hospitalisation

Measure: Hospitalisation

Time: 1 year

Description: General Anxiety Disorder (GAD-7) questionnaire (responses noted on Likert scales); min score 0 and max score 21. Higher score associated with greater anxiety

Measure: Participant anxiety

Time: 1 year

Description: Patient Health Questionnaire (PHQ-9) questionnaire (responses noted on Likert scales); min score 0 and max score 27. Higher score associated with greater depression.

Measure: Participant depression

Time: 1 year

179 A Clinical and Radiological Model to Predict the Prognosis for COVID-19 Patients

To develop and validate a machine-learning model based on clinical, laboratory, and radiological characteristics alone or combination of COVID-19 patients to facilitate risk Assessment before and after symptoms and triage (home, hospitalization inward or ICU).

NCT04337502 Coronavirus Machine Learning Diagnostic Test: Machine learning model

MeSH:Coronavi Coronavirus Infections

Primary Outcomes

Description: AUC, accuracy, sensitivity, and specificity

Measure: Predictive performance

Time: Janunary 1, 2020, to February 13, 2020

180 Gerontological Telemonitoring of Older Adults Living in Nursing Homes With Symptoms of Confirmed or Probable COVID-19 Disease

Since the last 3 months the world copes with the novel coronavirus disease : Covid-19 emerged in China in the end of 2019. WHO declared the pandemic situation as a Public Health Emergency around the world on January 2020. Firsts studies emphasized on higher risk to older adults to experience serious health consequences : hospitalizations and mortality, due to multimorbidity and multimedication. Nursing home resident are particulary frailer and vulnerable.

NCT04337788 Coronavirus Infection Other: telehealth applications

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Impact of Gerontological telemonitoring on healthcare management for older adults living in Nursing Homes with symptoms of confirmed or probable COVID-19 disease (Death within 30 days).

Time: day 30

181 Multi-Center, Randomized, Controlled, Phase II Clinical Efficacy Study Evaluating Nitric Oxide Releasing Solution Treatment for the Prevention and Treatment of COVID-19 in Healthcare Workers and Individuals at Risk of Infection

This is a multi-center, randomized, controlled, phase II clinical efficacy study evaluating a novel Nitric Oxide Releasing Solution (NORS) treatment for the prevention and treatment of COVID-19 in healthcare workers at risk of infection. Participants will be enrolled into one of two components of this study. Based on initial swabs/symptoms, volunteers who are COVID-19 negative will be enrolled in the Prevention study and randomized to receive standard institutional precautions or standard institutional precautions + NORS. Those who are COVID-19 positive will be enrolled in the open-label Treatment Sub-Study.

NCT04337918 Corona Virus Infection Drug: NORS (Nitric Oxide Releasing Solution) Drug: NORS (Nitric Oxide Releasing Solution)

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Measure the proportion of subjects with either swab positive COVID-19 or presentation of clinical symptoms as measured by fatigue with either fever >37.2 (oral)and/or a persistent cough.

Measure: Prevention Study: Measure the effect of NORS on the prevention of COVID-19 infection among health care professionals at risk of exposure to COVID-19

Time: 14 days

Description: Measure the proportion of participants requiring requiring hospitalization for COVID-19/flu-like symptoms and/or needing oxygen therapy, BIPAP/CPAP, intubation and mechanical ventilation following enrollment.

Measure: Treatment Sub Study: Measure the efficacy of NORS at reducing the progression of COVID- 19

Time: 21 days

Secondary Outcomes

Measure: Prevention Study: Measure the effect of NORS on the prevention of progression of COVID- 19

Time: 21 days

Description: Measure the tolerability of the NORS treatments as determined by number of adverse events, pain, discomfort or discontinuations of treatment.

Measure: Prevention Study: Measure the tolerability of NORS treatments

Time: 21 days

Description: Measure the median number of days to negative conversion of SARS-CoV-2 RT-PCR from a nasopharyngeal swabs.

Measure: Treatment Sub Study: Measure the virucidal effect of NORS Treatments

Time: 21 days

Description: Determine the time to clinical recovery in participants with COVID-19 by measuring the median number of days from enrollment to discharge (if admitted), or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air).

Measure: Treatment Sub Study: Determine effect of NORS on the speed of clinical recovery

Time: 21 days

Description: Measure the reduction clinical symptoms in participants with COVID- 19 by the magnitude of the change in Modified Jackson Cold Score Diary Score (5-unit change is a substantial clinical benefit).

Measure: Treatment Sub Study: Determine the reduction in clinical symptoms

Time: 21 days

Description: Measure the proportion of participants that have a positive sero-conversion for SARS-CoV-2

Measure: Treatment & Sub Study: Determine positive sero-conversion for SARS-CoV-2

Time: 21 days

182 The Randomized Elimination or Prolongation of Angiotensin Converting Enzyme Inhibitors and Angiotensin Receptor Blockers in Coronavirus Disease 2019

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for coronavirus disease 2019 (COVID-19), is associated with a high incidence of acute respiratory distress syndrome (ARDS) and death. Hypertension and cardiovascular disease are risk factors for death in COVID-19. Angiotensin converting enzyme 2 (ACE2), an important component of the renin-angiotensin system, serves as the binding site of SARS-CoV-2 and facilitates host cell entry in the lungs. In experimental models, angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) have been shown to increase ACE2 expression in several organs, potentially promoting viral cell invasion, although these findings are not consistent across studies. Alternatively, ACEIs and ARBs may actually improve mechanisms of host defense or hyperinflammation, ultimately reducing organ injury. Finally, ACEIs and ARBs may have direct renal, pulmonary and cardiac protective benefits in the setting of COVID-19. Therefore, it is unclear if ACEIs and ARBs may be beneficial or harmful in patients with COVID-19. Given the high prevalence of hypertension, cardiovascular and renal disease in the world, the high prevalence of ACEIs or ARBs in these conditions, and the clinical equipoise regarding the continuation vs. discontinuation of ACEIs/ARBs in the setting of COVID, a randomized trial is urgently needed. The aim of this trial is to assess the clinical impact of continuation vs. discontinuation of ACE inhibitors and angiotensin receptor blockers on outcomes in patients hospitalized with COVID-19.

NCT04338009 COVID-19 Other: Discontinuation of ARB/ACEI Other: Continuation of ARB/ACEI

MeSH:Coronavirus Infections

Primary Outcomes

Description: The primary endpoint of the trial will be a global rank score that ranks patient outcomes according to four factors: (1) time to death, (2) the number of days supported by invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), (3) the number of days supported by renal replacement therapy or pressor/inotropic therapy, and (4) a modified sequential Organ Failure Assessment (SOFA) score. The modified SOFA score will include the cardiac, respiratory, renal and coagulation domains of the SOFA score.

Measure: Hierarchical composite endpoint

Time: Up to 28 days

Secondary Outcomes

Measure: All-Cause Death

Time: Up to 28 days

Measure: Length of Hospital Stay

Time: Up to 28 days

Measure: Length of ICU Stay, invasive mechanical ventilation or extracorporeal membrane oxygenation

Time: Up to 28 days

Description: The Area Under the Curve of the modified SOFA (AUC SOFA) from daily measurements, weighted to account for the shorter observation period among patients who die in-hospital.

Measure: AUC SOFA

Time: Up to 28 days

Other Outcomes

Description: Composite

Measure: Intensive care unit admission or respiratory Failure Requiring Mechanical Ventilation.

Time: Up to 28 days

Description: Hypotension Requiring Vasopressors, inotropes or mechanical hemodynamic support (ventricular assist device or intra-aortic balloon pump).

Measure: Hypotension Requiring Vasopressors, inotropes or mechanical hemodynamic support

Time: Up to 28 days

Description: Number of days in 28-day period feee of invasive or non-invasive mechanical ventilation.

Measure: Number of 28-Day Ventilator-Free Days.

Time: Up to 28 days

Description: Difference between NT-proBNP at the time of randomization and the maximum value

Measure: Maximal change in NT-proBNP from baseline

Time: 28 days from enrollment

Description: as above

Measure: Change in serum creatinine between randomization and discharge (or time of death)

Time: Up to 28 days

Description: defined as Kidney Disease Improving Global Outcomes Stage 2 or higher or initiation of renal replacement therapy

Measure: Acute kidney injury during hospitalization

Time: Up to 28 days

Description: Proteinuria or Hematuria detected on urinalysis

Measure: Proteinuria or Hematuria

Time: Up to 28 days

183 Point Of Care UltraSonography to Perform Risk-stratification of Patients With Suspected or Confirmed COVID-19 - POCUSCO Study

COVID-19 pandemic has developed worldwide in less than 4 months. While most patients have a mild or uncomplicated disease (80%), approximately 15% need hospital care and 5% intensive care. Severe cases are characterized by pulmonary involvement which may progress to acute respiratory distress syndrome (ARDS). Early identification of patients who are likely to get worse is therefore a major issue. While, chest X-ray has poor diagnostic performances, pulmonary computed tomography (CT scan) seems very sensitive (97%) and quite specific of COVID-19. Sub-pleural bilateral ground-glass pattern can precede the positivity of RT-PCR for SARS-CoV-2. CT scan is now considered as the best imaging test to assess COVID-19 patients and is recommended as first-line diagnosis tool by the French Society of Radiology (SFR). However, performing CT scan in all or many patients with suspected COVID-19 may result in radiology department overload, especially, taking into account bio-cleaning between patients. Moreover, CT scan may lead to adverse effects including induced cancer due to the cumulative diagnostic irradiation. Chest ultrasonography may be an alternative to CT scan. It is a simple, non-invasive, non-irradiating, inexpensive and available at the point of care (POCUS). Most of emergency physicians and many other specialists (pneumologists, infectious disease or intensive care physicians) are trained to perform chest POCUS and use it in their everyday practice. Multiple studies have demonstrated its superiority to chest X-ray for the detection of pneumonia. In ARDS, a scoring has been developed and has shown good correlation with mortality. POCUS is very effective in detecting peripheral patterns and seems appropriate to explore COVID-19 patients. Previous studies suggest its interest in SARSCov2 infections for initial patient assessment and identification of lung damage. However, its performances have never been scientifically evaluated to date. Our main hypothesis is that point of care lung ultrasonography performed during the initial examination may identify high-risk COVID-19 patients.

NCT04338100 COVID Coronavirus Infection Procedure: Follow-up at 14 days

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: To assess, in patients with confirmed or probable SARS-CoV-2 infection, chest ultrasonography capacity, using the POCUS score for ARDS, to identify patients with unfavourable outcome at D14. Unfavourable outcome is defined by intubation with mechanical ventilation requirement or death (Stage ≥ 6 on "Ordinal Scale for Clinical Improvement" of the World Health Organization) within 14 days of inclusion. We will determine the 95% confidence interval of the AUC of the ROC curve and consider POCUS capacity as clinically relevant if the lower limit of the 95% confidence interval is at least 0.7.

Measure: Risk of unfavourable outcome at D14

Time: 14 days

Secondary Outcomes

Description: To evaluate, in patients with a confirmed or probable SARS-CoV-2 infection, whether POCUS score performances vary as a function of time, between D1 and D14, and, if so, until which time horizon its performances are clinically relevant. In this purpose, we will determine the time period for which the lower limit of the 95% confidence interval of the AUC of the POCUS score ROC curve is at least 0.7.

Measure: Risk of unfavourable outcome over time

Time: 14 days

Description: To identify the threshold values of POCUS score to perform risk-stratification in three groups of patients: low-risk patients, intermediate-risk patients, high-risk patients. In this purpose, we will determine two threshold values on the inflection points of the ROC curve: maximizing the specificity for a sensitivity of at least 95%, maximizing the sensitivity for a specificity of at least 95%.

Measure: Risk-stratification threshold values

Time: 14 days

Description: To study the impact of adding the result of POCUS evaluation to several risk-stratification clinical rules for pulmonary infection or sepsis: qSOFA, CRB 65 and CURB 65 In this purpose, we will attribute 0, 1 or 2 points to POCUS score according to the predefined threshold values and will assess : sensitivities of qSOFA with and without addition of POCUS score result, specificities of qSOFA with and without addition of POCUS score result; sensitivities of CRB 65 with and without addition of POCUS score result, specificities of CRB 65 with and without addition of POCUS score result; sensitivities of CRB 65 with and without addition of POCUS score result, specificities of CRB 65 with and without addition of POCUS score result.

Measure: Adding value of POCUS score to previous risk-stratification clinical rules

Time: 14 days

Description: To assess, the capacity of POCUS score at D0 to predict patient clinical status at D14 In this purpose, we will determine the correlation coefficient between the POCUS score at D0 and the clinical status of patients at day 14 according to the WHO Ordinal Scale for Clinical Improvement for COVID-19 patients.

Measure: POCUS score and patient clinical status at D14

Time: 14 days

Description: To study the correlation between POCUS and CT scan assessment of lung damage. In this purpose, we will determine the intra-class correlation coefficient between POCUS assessment according to the number of affected areas among 12 and CT scan assessment according to the quantification proposed by the French Society of Radiology: 0 - normal; 1 - minor (< 10%), 2 - moderate (10-25%), 3 - important (25-50%), 4 - severe (50-75%), 5 - critical (> 75%)

Measure: POCUS and CT scan correlation

Time: 14 days

Description: To compare the diagnostic performances of POCUS with that of chest computed tomography to identify patients with unfavourable outcome. In this purpose, we will compare the AUC of the ROC curves of POCUS score and CT scan quantification of lung damage to identify patients with unfavourable outcome (intubation and mechanical ventilation requirement or death)

Measure: POCUS versus CT scan risk-stratification performances

Time: 14 days

Description: To evaluate, in the subgroup of hospitalized patients having a second chest ultrasonography at Day 5 +/- 3 of inclusion, the performances of the evolution of the POCUS score between the first and the second assessment to identify patients with unfavourable outcome. In this purpose, we will calculate the delta between the first and second POCUS score and determine the AUC of the ROC curve and its 95% confidence interval.

Measure: POCUS score evolution performances

Time: 14 days

184 HOME-CoV: Hospitalization or Outpatient ManagEment of Patients With Confirmed or Probable SARS-CoV-2 Infection. A Before and After Implementation of a Consensus Help-decision Making Rule Study

COVID-19 pandemic has developed worldwide in less than 4 months. The clinical presentations are variable widely, ranging from simple rhinitis to major lung damage that can lead to death. In many countries involved in the ongoing health disaster due to SARS-CoV-2 infection, hospital are overloaded. In this context, the decision to hospitalize or to manage COVID-19 patients at home is crucial and defining reliable and consensual criteria is a major issue. HOME-CoV study is a multicentre quasi-experimental interventional study, before and after implementation of a help-decision making rule (HOME-CoV rule), developed via the Delphi method. Our main hypothesis is that a strategy based on the consensual HOME-CoV rule compared to current practice is at least as safe as regards the 7-day-rate of adverse events (safety criterion) and more effective as regards the rate of patients eventually managed as outpatients (efficacy criterion).

NCT04338841 Coronavirus Infection Other: HOME-CoV rule implementation

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Adverse outcomes include intubation with mechanical ventilation requirement and death (Stage ≥ 6 on "Ordinal Scale for Clinical Improvement" of the World Health Organization) within 7 days after inclusion.

Measure: the composite rate of adverse outcomes

Time: day 7

Description: The rate of patients hospitalized after admission to the emergency room including patients discharged home more than 24 hours after admission. It will be analyzed in a hierarchical approach, only if first primary objective is positive i.e. non-inferiority of HOME-CoV strategy versus current practice on the rate of adverse outcomes.

Measure: The rate of hospitalization

Time: 24 hours

185 COVID-19 Risk Stratification

We seek to derive and validate a clinically useful risk score for patients with Coronavirus Disease 2019 to aide clinicians in the safe discharge of patients.

NCT04339387 Coronavirus Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Patient with COVID-19 who does not require supplemental oxygen, does not require intensive care unit-level care, and does not die.

Measure: Suitable for discharge

Time: Duration of participation in cohort, expected to be between 1 day and 20 days.

186 Efficiency in Management of Organ Dysfunction Associated With Infection by the Novel SARS-CoV-2 Virus (COVID-19) Through a Personalized Immunotherapy Approach: the ESCAPE Clinical Trial

Our aim is to conduct one trial of personalized immunotherapy in patients with SARS-CoV-2 (COVID-19) associated with organ dysfunction and with laboratory findings of macrophage activation syndrome or immune dysregulation. These patients will be selected by the use of a panel of biomarkers and laboratory findings and they will be allocated to immunotherapy treatment according to their needs.

NCT04339712 COVID-19 Virus Diseases Macrophage Activation Syndrome Corona Virus Infection Drug: Anakinra Drug: Tocilizumab

MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Macrophage Activation Syndrome Virus Diseases

Primary Outcomes

Description: At least 25% decrease between baseline sequential organ failure assessment SOFA score and measured sequential organ failure assessment SOFA score at Study Day 8

Measure: Change of baseline total sequential organ failure assessment (SOFA) score

Time: Visit study day 8

Description: Resolution of all criteria of lower respiratory tract involvemed that led to study inclusion (except findings from imaging studies) at Study Day 8

Measure: Improvement of lung involvement measurements

Time: Visit study day 8

Description: At least 50% increase of pO2/FiO2 ratio between baseline and study visit Day 8

Measure: Increase of pO2/FiO2 ratio

Time: Visit Study Day 8

Secondary Outcomes

Description: Change of total sequential organ failure assessment (SOFA) score between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database (Sequential organ failure assessment range 0-24, high score associated with worst outcome)

Measure: Comparison of change of baseline total sequential organ failure assessment (SOFA) score in enrolled subjects towards historical comparators

Time: Screening, Day 8

Description: Change of lung involvement measurements between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database

Measure: Comparison of change of lung involvement measurements in enrolled subjects towards historical comparators

Time: Screening, Day 8

Description: Comparison of increase in pO2/FiO2 ratio towards historical comparators from Hellenic Sepsis Study Group Database

Measure: Comparison of pO2/FiO2 ratio in enrolled subjects towards historical comparators

Time: Screening, Day 8

Description: Change of Sequential organ failure assessment (SOFA) score on day 28 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)

Measure: Change of sequential organ failure assessment (SOFA) score

Time: Day 28

Description: Mortality on day 28

Measure: Rate of Mortality

Time: Day 28

Description: Mortality on day 90

Measure: Rate of Mortality

Time: Day 90

Description: Cytokine stimulation from peripheral blood mononuclear cells will be compared between days 0 and 4

Measure: Cytokine stimulation

Time: Screening, Day 4

Description: Gene expression of peripheral blood mononuclear cells will be compared between days 0 and 4

Measure: Gene expression

Time: Screening, Day 4

Description: Change of serum/plasma proteins between days 0 and 4

Measure: Serum/plasma proteins

Time: Screening, Day 4

Description: Classification of immune function of screened patients who are not enrolled in study drug since they are not characterized with MAS or immune dysregulation

Measure: Classification of the immune function

Time: Screening

187 Assessment of Exam Findings in Coronavirus Disease 2019 (COVID-19) With Point-of-Care Ultrasonography (POCUS)

Specific Aims: 1. The investigators will prospectively evaluate and analyze changes in the appearance of the lungs and heart through serial acquisition of focused point-of-care ultrasound images in a cohort of patients with or under investigation for COVID-19. 2. The investigators will correlate changes noted in ultrasound with clinical course and diagnostic evaluation to ascertain whether changes on ultrasound could improve care through earlier diagnosis or identification of patients at high risk of disease progression.

NCT04339998 Coronavirus Infection COVID Covid-19 SARS-CoV-2 Diagnostic Test: Point-of-Care Ultrasonography (POCUS)

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: POCUS is a 6-point scale evaluating the degree of abnormalities and number of sites with abnormalities in ultrasound images of the lungs. Higher scores indicate greater malady. Pulmonary POCUS Evaluation: B lines: absent (< 3 lines), present (> 3 lines), fused Consolidation: yes or no a. Bilateral: yes or no Pleural Effusion: yes or no Other pleural abnormalities: yes or no Score each finding based on degree of abnormalities and number of sites with abnormalities

Measure: POCUS Score - Lungs

Time: up to 14 days

Description: POCUS is a 6-point scale evaluating the degree of abnormalities and number of sites with abnormalities in ultrasound images of the heart. Higher scores indicate greater malady. Cardiac POCUS Evaluation: Parasternal long axis Parasternal short axis Qualitative LVEF: Normal, hyperdynamic, mild-moderately depressed, severely depressed EPSS (E-point septal separation): normal (<10 mm), abnormal (>10 mm) Left ventricular (LV) mass approximation by septal thickness Left Ventricular Chamber Size by internal diameter at diastole Score each finding based on degree of abnormalities and number of sites with abnormalities

Measure: POCUS Score - Heart

Time: up to 14 days

188 Pilot Study for Use of Convalescent Plasma Collected From Patients Recovered From COVID-19 Disease for Transfusion as an Empiric Treatment During the 2020 Pandemic at the University of Chicago Medical Center

The purpose of this study is to assess the feasibility of delivering anti-SARS-CoV-2 convalescent plasma to hospitalized patients with severe or life-threatening COVID-19. Beyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and could be rapidly available when there are sufficient numbers of people who have recovered and can donate high titer neutralizing immunoglobulin-containing plasma. Hypothesis: Collecting and administering convalescent plasma requires a level of logistical coordination that is not available in all centers. Objective: To establish feasibility for a hospital-based integrated system to collect and administer convalescent plasma to patients with severe or life-threatening COVID-19.

NCT04340050 Coronavirus Biological: anti-SARS-CoV-2 convalescent plasma

MeSH:Coronavirus Infections

Primary Outcomes

Description: Feasibility will be measured by (number of donors from whom convalescent plasma is harvested/number of interested donors) and number of patients who receive convalescent plasma at day 28.

Measure: Feasibility of performing study pathway consisting of consenting convalescent donors, harvesting convalescent plasma, application for FDA eIND and administering convalescent plasma to the patients

Time: 28 days after plasma administration

Description: Levels of respiratory support will be graded (e.g. room air, high flow oxygen, intubation) to determine the change in type of respiratory support at 28 days.

Measure: Type of respiratory support

Time: 28 days after plasma administration

Secondary Outcomes

Description: This will be a continuous outcome defined by the amount of time between plasma administration and cardiac arrest.

Measure: Cardiac arrest

Time: 28 days after plasma administration

Description: This will be a continuous outcome defined by the amount of time between plasma administration and transfer to ICU.

Measure: Transfer to ICU

Time: 28 days

Description: This will be a binary outcome defined by the amount of time between plasma administration and mortality in the ICU.

Measure: ICU mortality

Time: 28 days

Description: This will be a continuous outcome defined by the amount of time between plasma administration and discharge from ICU. This will be treated as a time-to-event.

Measure: ICU length of stay

Time: 28 days

Description: This will be a binary outcome defined by the amount of time between plasma administration and in-hospital mortality.

Measure: Hospital mortality

Time: 28 days

Description: This will be a continuous outcome defined by the amount of time between plasma administration and discharge from hospital.

Measure: Hospital length of stay

Time: 28 days

Description: This will be a continuous outcome defined by the amount of time between plasma administration and the transition from mechanical ventilation to non-invasive respiratory support.

Measure: Ventilator-free days

Time: 28 days

Description: 28-Day Overall Survival is defined as the status of the patient at the end of 28 days, beginning from the time of plasma administration.

Measure: Overall survival (28-day mortality)

Time: 28 days

189 French Multicentre Observational Study on SARS-Cov-2 Infections (COVID-19) ICU Management: the FRENCH CORONA Study

Since December 2019, a new agent, the SARS-Cov-2 coronavirus has been rapidly spreading from China to other countries causing an international outbreak of respiratory illnesses named COVID-19. In France, the first cases have been reported at the end of January with more than 60000 cases reported since then. A significant proportion (20-30%) of hospitalized COVID-19 patients will be admitted to intensive care unit. However, few data are available for this special population in France. We conduct a large observational cohort of ICU suspected or proven COVID-19 patients that will enable to describe the initial management of COVID 19 patients admitted to ICU and to identify factors correlated to clinical outcome.

NCT04340466 Pneumonia, Viral Critically Ill Corona Virus Infection Other: No intervention

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Critical Illness

HPO:Pneumonia

Primary Outcomes

Description: Mortality at day 28

Measure: Mortality at day 28

Time: day 28

Secondary Outcomes

Description: severe complications (pulmonary embolism, acute kidney injury, myocarditis, cardiac arrest, liver failure, ventilator associated pneumonia) Yes / No

Measure: severe complications

Time: up to day 28

Description: Delay in imaging in hours

Measure: Imaging

Time: day 1

Description: delay in microbiological diagnosis in hours

Measure: Delay in Microbiological diagnosis

Time: day 1

Description: Antiviral therapy Yes / no

Measure: Antiviral therapy

Time: up to day 28

Description: Antibiotic therapy Yes / No

Measure: Antibiotic therapy

Time: day 28

Description: Covid-19 treatments Yes / No

Measure: Covid-19 treatments

Time: up to day 28

Description: number

Measure: Patients receiving renal replacement therapy

Time: up to day 28

Description: number

Measure: Patients receiving mechanical ventilation

Time: up to day 28

Description: Patient alive at day 28 : yes / No

Measure: Vital status

Time: day 28

190 Randomized Open Label Study of Standard of Care Plus an Angiotensin II Receptor Blocker Compared to Standard of Care Alone to Minimize the Progression to Respiratory Failure in SARS-CoV-2 Infection

The purpose of this research is to identify whether or not Angiotensin Receptor Blockers (ARB) can halt the progression to respiratory failure requiring transfer into the intensive care unit (ICU), as well as halt mechanical ventilation in subjects with mild to moderate hypoxia due to the corona virus that causes COVID-19. Based on previous animal studies, the researchers hypothesize that the addition of an ARB is beneficial in abating acute lung injury in subjects in early stages of SARS-CoV-2 viral induced hypoxia.

NCT04340557 SARS-CoV Infection Drug: Losartan

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of subjects requiring transfer into ICU for mechanical ventilation due to respiratory failure

Measure: Mechanical ventilation

Time: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days

Secondary Outcomes

Description: Number of subjects transferred from non-ICU bed to an ICU bed

Measure: ICU transfer

Time: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days

Description: Number of days requiring oxygen therapy

Measure: Oxygen therapy

Time: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days

191 A Phase 1b/2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of TJ003234 in Subjects With Severe Coronavirus Disease 2019 (COVID-19)

This is a randomized, double-blind, placebo-controlled, multi-center trial to evaluate the safety and efficacy of TJ003234 administered as an intravenous (IV) infusion in subjects with severe COVID-19 under supportive care, and to assess the effect of TJ003234 on the levels of cytokines.

NCT04341116 Coronavirus Disease 2019 COVID-19 Drug: TJ003234 Drug: Placebo

MeSH:Coronavirus Infections

Primary Outcomes

Description: 8-category ordinal scale

Measure: Proportion (%) of subjects experiencing deterioration in clinical status

Time: Changes from baseline on Day 14

Description: Per CTCAE

Measure: Treatment Emergent Adverse Events

Time: Up to 30 days after drug administration

Secondary Outcomes

Description: 8-category ordinal scale

Measure: Proportion (%) of subjects experiencing deterioration in clinical status

Time: Changes from baseline on Day 7 and Day 30

Description: 8-category ordinal scale: 8, Death; 7, ventilation in addition to extracorporeal membrane oxygen (ECMO), continuous renal replacement therapy (CRRT) or pressors; 6, Intubation and mechanical ventilation; 5, non-invasive mechanical ventilation (NIV) or high-flow oxygen; 4,Oxygen by mask or nasal prongs; 3, Hospitalization without oxygen supplementation; 2, Limitation of activities, discharge from hospital; and 1, No limitation of activities, discharge from hospital

Measure: Clinical status

Time: On Day 7, Day 14 and Day 30

Measure: Improvement in clinical status

Time: On Day 7, Day 14 and Day 30

Description: The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. A higher score predicts a worse clinical outcome.

Measure: Sequential Organ Failure Assessment (SOFA) score

Time: On Day 7 and Day 14

Measure: Change from baseline in PaO2/ FiO2

Time: On Day 7 and Day 14

Description: Defined as SpO2≥94% sustained minimum 24 hours

Measure: Length of time to normalization of oxygen saturation

Time: Up to 30 days after drug administration

Measure: Change from baseline in percentage of subjects requiring mechanical ventilation

Time: On Day 7 and Day 14

Measure: Change from baseline in Glucocorticoid use

Time: On Day 7 and Day 14

Measure: Mortality rate from any cause

Time: Up to 30 days after drug administration

Measure: Length of hospitalization

Time: Up to 30 days after drug administration

Measure: Change from baseline in D-dimer

Time: On Day 7 and Day 14

Measure: Serum concentration of TJ003234

Time: Day 1 predose, Day 1 End of Infusion, Day 7 and Day 14

Measure: Incidence and titer of anti-drug antibodies (ADA)

Time: Day 1 predose, Day 14

192 Randomized Double Blinded Monocentric Clinical Trial to Assess the Impact of Auricular Vagus Nerve Neuromodulation in COVID-19 Positive Inpatients Outcome.

The COVID-19 pandemic has already overwhelmed the sanitary capacity. Additional therapeutic arsenals, albeit untested in the given context but previously proven to be efficacious in a related clinical context, that could reduce the morbidity rate are urgently needed. A decrease of Heart Rate Variability (HRV) is a validated bad prognosis marker in sepsis and acute respiratory distress syndrome. In contrast, auricular vagus nerve stimulation was proven not only to increase HRV values in healthy Humans, but also to reduce sepsis and increase survival, both significantly, in experimental models. Moreover, the heavy viral infection within the brainstem of deceased patients suggests that the neuroinvasive potential of SARS-CoV2 is likely to be partially responsible for COVID-19 acute respiratory failure and may bear relevance in tailoring future treatment modalities. Interestingly, the vagus nerve (or tenth cranial nerve) connects bidirectionally the brainstem to various internal organs including the lung and to one external organ, namely, the outer ear. Hence, the impact of auricular vagus nerve stimulation through semi-permanent needles will be studied, mostly used so far for pain alleviation, on the outcome of COVID-19 inpatients within 15 days.

NCT04341415 Covid19 SARS-CoV Infection Procedure: Auricular neuromodulation Procedure: Control

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Inpatients are considered as clinically improved if they have gained at least 2 points on the following clinical evaluation scale, or if they went back home Clinical evaluation scale :1. Outpatient back to normal activities / 2. Outpatient without normal activities / 3. Inpatient without oxygen therapy / 4. Inpatient with oxygen therapy/ 5. Inpatient requiring either nasal high-flow oxygen therapy or non-invasive respirator or both / 6. Inpatient, requiring either ExtraCorporeal Membrane Oxygenation (ECMO) or invasive artificial respirator, or both / 7. Deceased.

Measure: Comparison of the percentage of clinically improved inpatients between D0 and D14

Time: 14 day after intervention

193 Will Hydroxychloroquine Impede or Prevent COVID-19: WHIP COVID-19 Study

This is a prospective, multi-site study designed to evaluate whether the use of hydroxychloroquine in healthcare workers (HCW), Nursing Home Workers (NHW), first responders (FR), and Detroit Department of Transportation bus drivers (DDOT) in SE, Michigan, can prevent the acquisition, symptoms and clinical COVID-19 infection The primary objective of this study is to determine whether the use of daily or weekly oral hydroxychloroquine (HCQ) therapy will prevent SARS-CoV-2 infection and COVID-19 viremia and clinical COVID-19 infection healthcare workers (HCW) and first responders (FR) (EMS, Fire, Police, bus drivers) in Southeast Michigan. Preventing COVID-19 transmission to HCW, FR, and Detroit Department of Transportation (DDOT) bus drivers is a critical step in preserving the health care and first responder force, the prevention of COVID-19 transmission in health care facilities, with the potential to preserve thousands of lives in addition to sustaining health care systems and civil services both nationally and globally. If efficacious, further studies on the use of hydroxychloroquine to prevent COVID-19 in the general population could be undertaken, with a potential impact on hundreds of thousands of lives.

NCT04341441 COVID-19 Coronavirus Coronavirus Infections SARS-CoV 2 Drug: Hydroxychloroquine - Daily Dosing Drug: Hydroxychloroquine - Weekly Dosing Other: Placebo oral tablet Diagnostic Test: Monitoring Visit - Baseline Diagnostic Test: Monitoring Visit - Week 4 Diagnostic Test: Monitoring Visit - Week 8 Other: Weekly Assessment

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: We will measure the difference in new cases of COVID-19 disease between randomized treatment arms. Plan statistical analyses will include the assumption that up 10% of HCW at risk will become infected if no prophylactic treatment is provided. Therefore we expect that HCQ treatment arm will provide a reduction in the number of SARS-CoV 2 infections by 30%, with an expected study retention rate of 90%, a sample size of ~1500 participants per group, will have an 80% power to detect the difference at p=0.05.

Measure: To determine if the use of hydroxychloroquine as preventive therapy decreases the rate of acquisition of SARS-CoV 2 infections and clinical COVID-19 disease in Study Participants for each randomized treatment arm as compared to placebo.

Time: 8 Weeks

Secondary Outcomes

Description: Compare the rates of SARS-CoV 2 infections between the randomized treatment arms and the control arms to determine the effect of HCQ dose in the prevention of COVID-19 viremia and disease as determined by study visits, weekly questionnaires, and blood samples.

Measure: Determine the effect of hydroxychloroquine dose in the prevention of COVID-19 viremia and disease.

Time: 8 Weeks

Description: Comparison of the rates of SARS-CoV 2 infections in the non-randomized comparator arm to the randomized groups to assess the impact of chronic weight-based dosing of HCQ for COVID-19 prevention via weekly questionnaire and/or blood samples.

Measure: Assess the impact of chronic weight-based dosing of HCQ for COVID-19 prevention.

Time: 8 Weeks

Description: Measurement of the rate of SARS-CoV 2 infections as measured by IgM/IgG seroconversion in study participants receiving randomized HCQ versus placebo via blood samples.

Measure: Comparison of the rate of SARS-CoV 2 infections as measured by IgM/IgG seroconversion in study participants receiving randomized HCQ versus placebo.

Time: 8 Weeks

Description: Measurement of the seroprevalence of SARS-CoV 2 IgM/IgG positive samples at study entry and study conclusion in all participants receiving HCQ compared to those receiving placebo via blood samples.

Measure: Compare the seroprevalence of SARS-CoV 2 IgM/IgG positive samples at study entry and study conclusion in all participants receiving HCQ compared to those receiving placebo.

Time: 8 Weeks

Description: Measurement of the emergence of clinical symptoms or COVID-19 diagnosis in participants presenting asymptomatically at study entry but identified as seropositive by serology at entry between the randomized treatment arms and comparator arm and via weekly questionnaire and/or blood samples.

Measure: Comparison of the emergence of clinical symptoms or COVID-19 diagnosis in participants presenting asymptomatically at study entry but identified as seropositive by serology at entry between the randomized treatment arms and comparator arm.

Time: 8 Weeks

Description: Review of the level of care needed by participants in each arm developing COVID19 as measured as requiring emergency room visit, hospitalization or able to stay home without hospital care via weekly questionnaire.

Measure: To examine the level of care needed by participants in each arm developing COVID19 as measured as requiring emergency room visit, hospitalization or able to stay home without hospital care.

Time: 8 Weeks

Description: Measurement of the safety and tolerability of HCQ dosing for preventive strategy against COVID-19 as measured by adverse events and serious adverse events reported via weekly questionnaire.

Measure: Determine the safety and tolerability of HCQ dosing for preventive strategy against COVID-19 as measured by adverse events and serious adverse events.

Time: 8 Weeks

Description: Examination of other clinical determinants contributing to the risk of SARS-CoV 2 infection including demographics, work type and location, positive COVID-19 partners, possible exposures and clinical symptoms via study visits and weekly questionnaire.

Measure: To examine other clinical determinants contributing to the risk of SARS-CoV 2 infection in healthcare workers and first responders.

Time: 8 Weeks

Description: Examine the association between HCQ drug levels and development of COVID-19 symptoms or positive test results via weekly questionnaire and/or blood samples.

Measure: Examine the association between HCQ drug levels and development of COVID-19 symptoms or positive test results.

Time: 8 Weeks

Description: Identification of immunologic, serological and inflammatory markers associated with acquisition and response to COVID-19 in both HCQ and placebo Participants developing laboratory or clinical confirmed disease via study visits, weekly questionnaire, and blood samples.

Measure: identify immunologic, serological and inflammatory markers associated with acquisition and response to COVID-19 in both HCQ and placebo Participants developing laboratory or clinical confirmed disease.

Time: 8 weeks

194 Treatment With Hydroxychloroquine vs Nitazoxanide + Hydroxychloroquine in Patients With COVID-19 With Risk Factors for Poor Outcome

Coronaviruses (CoV) are positive-sense single-stranded RNA viruses that infect a wide range of hosts producing diseases ranging from the common cold to serious / fatal events. Nitazoxanide (NTZx) is a derivative of 5-nitrothiazole, synthesized in 1974 by Rosignol - Cavier. NTZx has powerful antiviral effects through the phosphorylation of protein kinase activated by double-stranded RNA, which leads to an increase in phosphorylated factor 2-alpha, an intracellular protein with antiviral effects. The purpose of this study is to contrast the beneficial effect of NTZx vs NTZx plus hydroxychloroquine in patients Coronavirus Disease (COVID-19) as well as against other treatments.

NCT04341493 Coronavirus Infection Drug: Nitazoxanide 500 MG Drug: Hydroxychloroquine

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Percentage of patients COVID-19 positive that required mechanical ventilation

Measure: Mechanical ventilation requirement

Time: Since the diagnosis until two weeks after

195 "Psychological Burden in ICU Survivors of Severe COVID-19 Pneumonia, Their Relatives and Their Healthcare Providers" "Impact Psychologique de l'épidémie COVID-19 Chez Les Patients, Familles et Soignants de Reanimation" "BURDENCOV"

Coronavirus disease 2019 (COVID-19) is an infectious disease responsible for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The infection is highly contagious requiring restrictive and stressful measures for patients, family members and ICU healthcare providers. To avoid contagion, patient isolation has become the rule. For patients, these measures add stress to the ICU environment and deprive them of unrestricted family visits. Family members are not only left with fear but also many unanswered questions. In end-of-life situations, many family members are unable to say good-bye and unable to provide support to their loved-one throughout the process. The impact of exclusion or limited inclusion certainly needs to be explored. Moreover, ICU caregivers are having to face new challenges and to work in a unknown situation, juggling with both professional issues such as increased workload, working longer hours and safety issues, and personal issues such as child care and transport as well as family transmission of the virus. The main objective of this study is to demonstrate that the COVID-19 pandemic, as compared to seasonal flu and community acquired pneumonia, significantly increases post-traumatic stress disorder (PTSD) in family members of critically ill patients. PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge. The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events. It will be compared across the three groups (COVID-19, FLU and CAP).

NCT04341519 Corona Virus Infection Post-traumatic Stress Disorder Behavioral: PTSD Behavioral: Burnout

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

HPO:Pneumonia

Primary Outcomes

Description: Proportion of Family members with IES-R> 22 PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge of corresponding patient. It si a scale ranging from 0 to 88. Weiss, DS.; Marmar, CR. The impact of event scale - revised. In: Wilson, JP.; Keane, TM., editors.Assessing psychological trauma and PTSD. New York: Guilford Press; 1997. p. 399-411

Measure: PTSD Family members sup 22

Time: 90 days

Secondary Outcomes

Description: Among Family members PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)

Measure: PTSD Family members

Time: 90 days

Description: Among Patients PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)

Measure: PTSD Patients

Time: 90 days

Description: Among healthcare providers PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)

Measure: PTSD healthcare providers

Time: 2 months after official end of the Covid-19 peak

Description: Among Family members Symptoms of anxiety and depression using the HADS scale

Measure: HADS Family members

Time: 90 days

Description: Among Patients Symptoms of anxiety and depression using the HADS scale

Measure: HADS Patients

Time: 90 days

Description: Among Patients Mental and physical health-related quality of life as assessed by the SF36

Measure: SF36 Patients

Time: 90 days

Description: Among Family members Questionnaire describing their experience of the patient's ICU hospitalization

Measure: Questionnaire Family members

Time: 90 days

Description: Among Patients Questionnaire describing their experience of the patient's ICU hospitalization

Measure: Questionnaire Patients

Time: 90 days

Description: Among healthcare providers Questionnaire describing their experience of the patient's ICU hospitalization

Measure: Questionnaire healthcare providers

Time: 2 months after official end of the Covid-19 peak

Description: Among healthSymptoms of burnout on MBI scale as assessed by the Maslash Burnout Inventorycare providers

Measure: MBI healthcare providers

Time: 2 months after official end of the Covid-19 peak

Description: Job Strain as assessed by the Karasec instrument

Measure: Karasec instrument healthcare providers

Time: 2 months after official end of the Covid-19 peak

196 CORIMUNO-ANA: Trial Evaluating Efficacy Of Anakinra In Patients With Covid-19 Infection, Nested In The CORIMUNO-19

The overall objective of the study is to determine the therapeutic effect and tolerance of Anakinra in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Anakinra (ANA) is a recombinant human decoy IL-1Ra and therefore blocks IL-1α and IL-1β. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Anakinra administration to patients enrolled in the COVIMUNO-19 cohort. Anakinra will be administered to consenting adult patients hospitalized with CORVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Anakinra will receive standard of cares. Outcomes of Anakinra -treated patients will be compared with outcomes of standard of care treated patients as well as outcomes of patients treated with other immune modulators.

NCT04341584 Corona Virus Infection Drug: Anakinra

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Survival without needs of ventilator utilization at day 14

Time: 14 days

Measure: WHO progression scale ≤ 5

Time: 4 days

Measure: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) or withdrawal of NIV or high flow (for > 48h), at day 14

Time: 14 days

Description: Proportion of patients with a decrease of WHO score of at least 1 point at day 4

Measure: Decrease of at least one point in WHO progression scale score

Time: 4 days

Secondary Outcomes

Measure: WHO progression scale

Time: 7 and 14 days

Description: Overall survival.

Measure: Survival

Time: 14, 28 and 90 days

Measure: 28-day ventilator free-days

Time: 28 days

Description: arterial blood pH of <7.25 with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours.

Measure: Respiratory acidosis

Time: 4 days

Description: Evolution of PaO2/FiO2 ratio.

Measure: PaO2/FiO2 ratio

Time: day 1 to day 14

Description: Time to oxygen supply independency.

Measure: Time to oxygen supply independency

Time: 14 days

Description: Duration of hospitalization.

Measure: Duration of hospitalization

Time: 90 days

Description: Time to negative viral excretion.

Measure: Time to negative viral excretion

Time: 90 days

Description: Time to ICU discharge.

Measure: Time to ICU discharge

Time: 90 days

Description: Time to hospital discharge.

Measure: Time to hospital discharge

Time: 90 days

197 WU 352: Open-label, Randomized Controlled Trial of Hydroxychloroquine Alone or Hydroxychloroquine Plus Azithromycin or Chloroquine Alone or Chloroquine Plus Azithromycin in the Treatment of SARS CoV-2 Infection

This Phase III trial four treatment strategies non-critically ill hospitalized participants (not requiring ICU admission and/or mechanical ventilation) with SARS CoV-2 infection, Participants will receive hydroxychloroquine or chloroquine with or without azithromycin.

NCT04341727 Coronavirus Infection Drug: Hydroxychloroquine Sulfate Drug: Azithromycin Drug: Chloroquine Sulfate

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Time (hours) from randomization to recovery defined as 1) absence of fever, as defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications AND 2) absence of symptoms of greater than mild severity for 24 hours AND 3) not requiring supplemental oxygen beyond pre-COVID baseline AND 4) freedom from mechanical ventilation or death

Measure: Hours to recovery

Time: 42 days

Secondary Outcomes

Description: Time to resolution of fever defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications

Measure: Time fever resolution

Time: 42 days

198 Predictive Biomarkers of Secondary Aggravation in Covid-19 Suspect Patient Admitted to Emergency Departments During an Epidemic

There is no predictive tool for patients admitted to the emergency department with a suspicion of Covid-19 that will worsen secondarily and require a heavy lifting. In a context of saturation of the healthcare system by the pandemic at Covid-19,it is essential to identify specific, accessible prognostic markers via minimally invasive sampling with low risk of infection for personnel caregiver, for optimal allocation of resuscitation resources. This study proposes to evaluate the biological markers of routine care known to be associated with resuscitation admission in relation to hospitalization on conventional service for the prediction of worsening of patients admitted to the emergencies for Covid-19.

NCT04341792 Infection Viral Coronavirus COVID-19

MeSH:Coronavirus Infections Virus Diseases

Primary Outcomes

Description: Secondary aggravation is defined as : a re-hospitalization or aggravation in hospitalization : development or increase in oxygen dependency, hemodynamic failure, and/or respiratory, death

Measure: Rate of secondary aggravation

Time: an average at 30 days (- 2 days +3 days) of admission to the emergency department

Secondary Outcomes

Description: the number of leukocytes, lymphocytes, neutrophil polynuclear cells, CRP, fibrinogen, and the D-dimers.

Measure: Change of standart biological parameters

Time: Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department

Measure: Change of Von willebrand factor (vWF) changes over time

Time: Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department

Measure: Change of the Factor VIII (FVIII)

Time: Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department

Measure: Prevalence of positivity of COVID-19 virus measured by PCR or serology

Time: an average at 30 days (- 2 days +3 days) of admission to the emergency department

199 Effects of DPP4 Inhibition on COVID-19 Patients With Type 2 Diabetes

The purpose of this research is to see if the DPP4 inhibitor linagliptin, an oral medication commonly used to treat type 2 diabetes,can help with diabetes control and reduce the severity of the COVID-19 infection

NCT04341935 Coronavirus Infection Type 2 Diabetes Drug: Linagliptin Drug: Insulin regimen

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Diabetes Mellitus, Type 2

HPO:Type II diabetes mellitus

Primary Outcomes

Description: Change in glucose control will be assessed via glucose levels obtained from blood serum samples

Measure: Changes in Glucose Llevels

Time: Baseline, up to 2 weeks

Secondary Outcomes

Description: changes in SpO2 will be measured with a Pulseimetry, an indirect, non-invasive method

Measure: Changes in SpO2 levels

Time: Baseline, up to 2 weeks

Description: Changes in IL 6 will be assessed from blood serum samples

Measure: Changes in Interleukin 6 (IL6)

Time: Baseline, up to 2 weeks

Description: Changes in Chest radiography (X-ray)

Measure: Changes in chest structures

Time: Baseline, up to 2 weeks

200 Safety And Efficacy Of Hydroxychloroquine For At Risk Population (SHARP) Against COVID-19- A Cluster Randomized Controlled Trial (SHARP COVID-19 RCT)

The Coronavirus Disease 2019 (COVID-19) pandemic has placed tremendous stress on the global economy since its outbreak in December 2019. Currently, with nearly 1.3 million confirmed cases, there is still no effective way to contain the disease. The transmission of COVID-19 occurs via direct (prolonged close interaction, within 2 meters for more than 30 minutes) and indirect (fomites) contacts. Locally, the risk of COVID-19 infection in household contacts of confirmed cases is about 4%. These at-risk individuals are identified through contact tracing and infectious may be preventable using post-exposure-prophylaxis (PEP). However, there has yet to be a single effective, safe, and affordable pharmacological agent with such capabilities. Hydroxychloroquine (HCQ) is a cheap anti-malarial and immunomodulatory agent which may potentially be used as PEP against COVID-19. HCQ is capable of blocking the invasion and intracellular replication of the virus. Existing studies have reported efficacy of HCQ in treating COVID-19, with reduced time to clinical recovery and few reports of patients suffering from significant side effects. However, existing studies are largely limited by their small sample sizes. Furthermore, there has yet to be a published trial on HCQ's role in PEP. This cluster randomized trial will evaluate the safety and efficacy of oral HCQ PEP, taken over for 5 days, in reducing the number of infected household contacts of confirmed COVID-19 patients under home quarantine. Comparison will be made between HCQ PEP (treatment group) and no treatment (control group). Subjects will be followed up over a course of 28 days, with daily symptom monitoring conducted over phone calls. Positive outcomes from this study will provide a means for us to battle the COVID-19 pandemic.

NCT04342156 Coronavirus Infection Hydroxychloroquine Adverse Reaction Drug: Hydroxychloroquine Sulfate 200 milligram (mg) Tab

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: COVID-19 infection

Measure: positive serology or reverse transcriptase (RT-PCR) for COVID-19 up until day 28.

Time: Until day 28

Secondary Outcomes

Description: Serology

Measure: Positive serology at day 28.

Time: 28 days

Description: COVID-19

Measure: Symptoms of COVID-19.

Time: Until day 28

201 Hydroxychloroquine for Outpatients With Confirmed COVID-19

A novel coronavirus, SARS-CoV-2, is responsible for a rapidly spreading pandemic that has reached 160 countries, infecting over 500,000 individuals and killing more than 24,000 people. SARS-CoV-2 causes an acute and potentially lethal respiratory illness, known as COVID-19, that is threatening to overwhelm health care systems due to a dramatic surge in hospitalized and critically ill patients. Patients hospitalized with COVID-19 typically have been symptomatic for 5-7 days prior to admission, indicating that there is a window during which an effective intervention could significantly alter the course of illness, lessen disease spread, and alleviate the stress on hospital resources. There is no known treatment for COVID-19, though in vitro and one poorly controlled study have identified a potential antiviral activity for HCQ. The rationale for this clinical trial is to measure the efficacy and safety of hydroxychloroquine for reducing viral load and shedding in adult outpatients with confirmed COVID-19.

NCT04342169 Coronavirus Infection Coronavirus Infectious Disease Drug: Hydroxychloroquine Drug: Placebo oral tablet

MeSH:Communicable Diseases Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Duration of viral shedding

Time: Days 1-14

Secondary Outcomes

Measure: Duration of COVID-19-attributable symptoms

Time: Everyday through 6 months

Measure: Hospitalization

Time: within 14 days of enrollment

Measure: Duration of viral shedding

Time: Days 1-14 and Day 28

Measure: Adult household contact viral acquisition

Time: Days 1-14 and Day 28

202 Acquiring Convalescent Specimens to Isolate and Identify Potent Monoclonal Antibodies Against COVID-19

Blood samples from participants who have recovered from COVID-19 infection will be obtained and studied. The goal of the research is to identify antibodies that have been generated by the patient to fight the COVID-19 infection. By identifying the most effective antibodies, scientists can make specific antibodies to use to prevent future coronavirus outbreaks or to treat patients with severe disease.

NCT04342195 COVID-19 Coronavirus Infection Corona Virus Infection Procedure: Blood draw

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The blood specimen will be proceeded into peripheral blood mononuclear cells and plasma to be stored for testing. In brief, CD27+ memory B cells that can bind to a SARS-CoV-2 S protein bait will be sorted by flow cytometry and RNA will be extracted to obtain heavy and light chain sequences. Antibody sequences will be annotated using bioinformatics approaches, and candidate sequences will be cloned. Purified antibodies will be characterized and neutralization breadth and potency against SARS-CoV-2 and other related coronaviruses will be assessed using neutralization assays.

Measure: Number of antibodies against coronaviruses isolated and identified from patient samples

Time: Up to 12 months after collection visit

203 Phase IIb Study to Evaluate the Efficacy and Safety of Chloroquine Diphosphate in the Treatment of Patients With Comorbidities, Without Severe Acute Respiratory Syndrome, Under the New Coronavirus (SARS-CoV2): a Double-blind, Randomized, Placebo-controlled Clinical Trial

This is a double-blind, randomized, placebo-controlled clinical trial. A total of 210 individuals aged over 18 years old, without a diagnosis of severe respiratory disease, who came to the study site with clinical and radiological suspicion of SARS-CoV2, will be randomized into two treatment groups at a 1:1 ratio to receive a 5-day CQ diphosphate tablets or placebo (tablet without active ingredient produced with the same physical characteristics).

NCT04342650 COVID-19 SARS-CoV Infection Severe Acute Respiratory Syndrome (SARS) Pneumonia Clinical Trial Drug: Chloroquine Diphosphate Drug: Placebo oral tablet

MeSH:Infection Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia Syndrome

HPO:Pneumonia

Primary Outcomes

Description: Evaluate if CQ diphosphate prevents the onset of SARS in patients on intervention group through standardized questionnaires.

Measure: Proportion of patients with onset of severe acute respiratory syndrome (SARS)

Time: 7 days after randomization

Secondary Outcomes

Description: Mortality rate between intervention and placebo group on days 7, 14, and 28 after randomization

Measure: Mortality rate

Time: after randomization, up to 28 days

Description: Proportion of participants in need and duration of intensive care support after randomization

Measure: Number of participants in need of intensive care support

Time: during and after intervention, up to 28 days

Description: Viral load change in blood and oropharyngeal swab samples

Measure: Viral concentration

Time: After randomization, up to 7 days

Description: Incidence of serious adverse events during and after treatment

Measure: Cumulative incidence of serious adverse events

Time: During and after intervention, up to 28 days

Description: Incidence of grade 3 and 4 adverse events during and after treatment

Measure: Cumulative incidence of grade 3 and 4 adverse events

Time: During and after intervention, up to 28 days

Description: proportion of discontinuation or temporary suspension of treatment (for any reason)

Measure: Proportion of patients with discontinued treatment

Time: after randomization, up to 28 days

Description: proportion of patients with increased levels of troponin I

Measure: Incidence of cardiac lesions

Time: after randomization, up to 120 days

Description: proportion and magnitude of QTcF interval increases higher than 500ms

Measure: Incidence of cardiac disfunctions

Time: after randomization, up to 120 days

Description: Changes measured on day 120 will be compared to baseline, through spirometry.

Measure: Change in respiratory capacity

Time: Day 120 after randomization

204 A Double-blind, Placebo-controlled Clinical Trial of Fluvoxamine for Symptomatic Individuals With COVID-19 Infection

The purpose of this research study is to determine if a drug called fluvoxamine can be used early in the course of the COVID-19 infection to prevent more serious complications like shortness of breath. Fluvoxamine is an anti-depressant drug approved by the FDA for the treatment of obsessive-compulsive disorder. The use of fluvoxamine for the treatment of COVID-19 is considered investigational, which means the US Food and Drug Administration has not approved it for this use. This study is fully-remote, which means that there is no face-to-face contact; study materials including study drug will be shipped to participants' houses. Only residents of Missouri and Illinois may participate.

NCT04342663 COVID 19 Coronavirus Drug: Fluvoxamine Drug: Placebo

MeSH:Infection Coronavirus Infections

Primary Outcomes

Description: Clinical worsening is defined meeting both of the following: (1) presence of dyspnea and/or hospitalization for shortness of breath or pneumonia, plus (2) decrease in O2 saturation (<92%) on room air and/or supplemental oxygen requirement in order to keep O2 saturation >92%.

Measure: Time to clinical worsening

Time: RCT (approximately 15 days)

Secondary Outcomes

Description: (1) moderate severity of illness as defined by O2 saturation <92% but no supplemental oxygen requirement; (2) O2 saturation plus supplemental oxygen requirement; (3) O2 saturation <92% plus hospitalization (related to dyspnea/hypoxia); (4) the above, plus ventilator support requirement; (5) the above, plus ventilator support for at least 3 days; (6) death.

Measure: clinical deterioration on a Likert-type scale (1-6)

Time: RCT (approximately 15 days)

Description: (1) requiring supplemental oxygen; (2) requiring hospitalization; (3) requiring ventilator support.

Measure: clinical deterioration measured by number of days

Time: RCT (approximately 15 days)

Description: Outcomes will be collected daily, with symptomatic data collected approximately twice daily. The most severe symptom at baseline will be the focus.

Measure: Symptomatic severity on a likert scale (0-10 where 0= none and 10=very severe)

Time: RCT (approximately 15 days)

205 Coronavirus Disease 2019- Using Ascorbic Acid and Zinc Supplementation (COVIDAtoZ) Research Study A Randomized, Open Label Single Center Study

The purpose of this study is to examine the impact of ascorbic acid (vitamin c) and zinc gluconate in reducing duration of symptoms in patients diagnosed with coronavirus disease 2019 (COVID-19). Patients above the age of 18 who present to the Cleveland Clinic outpatient testing and receive a positive test for COVID-19 will be invited to participate.

NCT04342728 COVID Corona Virus Infection Dietary Supplement: Ascorbic Acid Dietary Supplement: Zinc Gluconate Dietary Supplement: Ascorbic Acid and Zinc Gluconate Other: Standard of Care

MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of days to reach a 50 percent reduction in the cumulative 0-36 symptom score with each symptom evaluated on a 0-3 scale. Assessed symptoms are Fever, Cough, Shortness of Breath, Fatigue, Muscle or body aches, Headache, New loss of taste, New loss of smell, Congestion or runny nose, Nausea, Vomiting, Diarrhea. Each patient will have a composite score ranging from 0-36/day

Measure: Symptom Reduction

Time: 28 days

Secondary Outcomes

Description: The number of days required to reach a score of 0 from the symptom category of fever based on a 0-3 scale: 0 = ≤98.6, 1 = >98.6- 100.6, 2 = > 100.6 - 102.6, 3 = >102.6

Measure: Symptom Resolution: Fever

Time: 28 days

Description: The number of days required to reach a score of 0 from the symptom category of cough based on a 0-3 scale: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe

Measure: Symptom Resolution: Cough

Time: 28 days

Description: The number of days required to reach a score of 0 from the symptom category of shortness of breath based on a 0-3 scale: 0 = no shortness of breath, 1 = with moderate intensity exercise 2 = with walking on flat surface 3 = short of breath with getting dressed or daily activities

Measure: Symptom Resolution: Shortness of Breath

Time: 28 days

Description: The number of days required to reach a score of 0 from the symptom category of fatigue based on a 0-3 scale: 1=mild fatigue, 2=moderate fatigue, 3=severe fatigue.

Measure: Symptom Resolution: Fatigue

Time: 28 days

Description: The number of days required to reach a score of 0 from the symptom category of muscle/body aches based on a 0-3 scale: 1=mild muscle/body aches, 2=moderate muscle/body aches , 3=severe muscle/body aches.

Measure: Symptom Resolution: Muscle/body aches

Time: 28 days

Description: The number of days required to reach a score of 0 from the symptom category of headache based on a 0-3 scale: 1=mild headache, 2=moderate headache, 3=severe headache.

Measure: Symptom Resolution: Headache

Time: 28 days

Description: The number of days required to reach a score of 0 from the symptom category of new loss of taste based on a 0-3 scale: 1=mild loss of taste, 2=moderate loss of taste, 3=severe loss of taste.

Measure: Symptom Resolution: New loss of taste

Time: 28 days

Description: The number of days required to reach a score of 0 from the symptom category of new loss of smell based on a 0-3 scale: 1=mild loss of smell, 2=moderate loss of smell, 3=severe loss of smell.

Measure: Symptom Resolution: New loss of smell

Time: 28 days

Description: The number of days required to reach a score of 0 from the symptom category of congestion/runny nose on a 0-3 scale: 1=mild congestion/runny nose , 2=moderate congestion/runny nose , 3=severe congestion/runny nose .

Measure: Symptom Resolution: Congestion/ runny nose

Time: 28 days

Description: The number of days required to reach a score of 0 from the symptom category of nausea on a 0-3 scale: 1=mild nausea, 2=moderate nausea, 3=severe nausea.

Measure: Symptom Resolution: Nausea

Time: 28 days

Description: The number of days required to reach a score of 0 from the symptom category of vomiting on a 0-3 scale: 1=mild vomiting, 2=moderate vomiting, 3=severe vomiting.

Measure: Symptom Resolution: Vomiting

Time: 28 days

Description: The number of days required to reach a score of 0 from the symptom category of diarrhea on a 0-3 scale: 1=mild diarrhea, 2=moderate diarrhea, 3=severe diarrhea.

Measure: Symptom Resolution: Diarrhea

Time: 28 days

Description: Total symptom composite score at day 5 of study supplementation: Symptom categories of fever based on a 0-3 scale: 0 = ≤98.6, 1 = >98.6- 100.6, 2 = > 100.6 - 102.6, 3 = >102; Cough on a 0-3 scale: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe; Shortness of Breath on a 0-3: 0 = no shortness of breath, 1 = with moderate intensity exercise 2 = with walking on flat surface 3 = short of breath with getting dressed or daily activities; and Fatigue on a 0-3 scale: 0 = No fatigue/energetic, 1=mild fatigue, 2=moderate fatigue, 3=severe fatigue.

Measure: Day 5 Symptoms

Time: 5 days

Description: Differences in hospitalization events between the study arms

Measure: Hospitalizations

Time: 28 days

Description: Differences in severity of symptoms between study arms

Measure: Severity of Symptoms

Time: 28 days

Description: Differences in number of patients who were prescribed adjunctive medications for their diagnosis between study arms

Measure: Adjunctive Medications

Time: 28 days

Description: Differences in number of patients in study arms who experienced side effects from the supplements.

Measure: Supplementation Side Effects

Time: 28 days

206 A Multicenter, Prospective Study of COVID-19 Using Real-Time Syndromic Surveillance, Scheduled At-home Serologic Testing, and Electronic Health Records

The purpose of this research is to collect information about the North Carolina community's coronavirus exposures, symptoms, and health care visits due to the virus. Participation in this study will involve completing a daily questionnaire which covers participants coronavirus illness history or symptoms, health care seeking behaviors and treatments, contact with other sick people, and for health care workers, their use of personal protective equipment.

NCT04342884 Coronavirus COVID

MeSH:Coronavirus Infections

Primary Outcomes

Description: Percent of volunteers who are 2019-nCoV Ab test positive

Measure: Seroprevalence of SARS-CoV-2 infection in the general population of North Carolina

Time: baseline

Description: Percent of volunteers who are 2019-nCoV Ab test positive

Measure: Seroprevalence of SARS-CoV-2 infection among health care workers of North Carolina

Time: baseline

Secondary Outcomes

Measure: Cumulative incidence of SARS-CoV-2 infection

Time: 12 month

Measure: Monthly incidence of SARS-CoV-2 infection

Time: Month 1 thru month 12

Measure: Stratified incidence of SARS-CoV-2 infection by age group

Time: Month 1 thru month 12

Measure: Stratified incidence of SARS-CoV-2 infection by sex

Time: Month 1 thru month 12

Measure: Stratified incidence of SARS-CoV-2 by season

Time: Month 1 thru month 12

Measure: Stratified incidence of SARS-CoV-2 infection by geographic area (zip code)

Time: Month 1 thru month 12

Measure: Stratified incidence of SARS-CoV-2 infection by preexisting comorbidities

Time: Month 1 thru month 12

Measure: Stratified incidence of SARS-CoV-2 infection by COVID-2 contacts

Time: Month 1 thru month 12

Measure: Stratified incidence of SARS-CoV-2 infection by use of personal protective equipment (PPE) by health workers

Time: Month 1 thru month 12

Measure: Relative risk of SARS-CoV-2 infection by age group

Time: Month 1 thru month 12

Measure: Relative risk of SARS-CoV-2 infection by sex

Time: Month 1 thru month 12

Measure: Relative risk of SARS-CoV-2 infection by season

Time: Month 1 thru month 12

Measure: Relative risk of SARS-CoV-2 infection by geographic area (zip code)

Time: Month 1 thru month 12

Measure: Relative risk of SARS-CoV-2 infection by preexisting comorbidities

Time: Month 1 thru month 12

Measure: Relative risk of SARS-CoV-2 infection by COVID-2 contacts

Time: Month 1 thru month 12

Measure: Relative risk of SARS-CoV-2 infection by use of PPE by health workers

Time: Month 1 thru month 12

Measure: Incidence of sequelae

Time: Month 1 thru month 12

207 Patterns and Changes in Platelet Reactivity, Thrombotic Status and Endothelial Function in Hospitalized Patients With SARS-Cov-2 Infection

The present study is ideated to prospectively investigate in patients with severe acute respiratory syndrome (SARS) due to Coronavirus 19 (SARS-Cov-2) infection and moderate-severe respiratory failure the patterns and changes in platelet reactivity, thrombotic status and endothelial function. The observed patterns and changes will be related with inflammatory status, myocardial injury and outcomes

NCT04343053 Severe Acute Respiratory Syndrome Coronavirus 2 Other: SARS-Cov-2 infection

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: patterns and changes of platelet aggregation values assessed by light transmission aggregometry after arachidonic acid, adenosine diphosphate and thrombin receptor activating peptide stimuli

Measure: on-treatment platelet reactivity

Time: early stage of disease (first 96 hours)

Measure: on-treatment platelet reactivity

Time: mid stage of disease (96 hours - 14 days)

Measure: on-treatment platelet reactivity

Time: late stage of disease (>14 days)

Secondary Outcomes

Description: patterns and changes of the rate of apoptosis in HUVEC incubated with serum from patients enrolled in the study.

Measure: apoptosis rate in human umbilical vein endothelial cells (HUVEC)

Time: early stage of disease (first 96 hours)

Description: patterns and changes of the rate of apoptosis in HUVEC incubated with serum from patients enrolled in the study.

Measure: apoptosis rate in human umbilical vein endothelial cells (HUVEC)

Time: mid stage of disease (96 hours - 14 days)

Description: patterns and changes of intracellular level of NO in HUVEC incubated with serum from patients enrolled in the study.

Measure: Nitric oxide (NO) intracellular levels

Time: late stage of disease (>14 days)

Description: patterns and changes of intracellular level of NO in HUVEC incubated with serum from patients enrolled in the study.

Measure: Nitric oxide (NO) intracellular levels

Time: early stage of disease (first 96 hours)

Description: patterns and changes of intracellular level of NO in HUVEC incubated with serum from patients enrolled in the study.

Measure: Nitric oxide (NO) intracellular levels

Time: mid stage of disease (96 hours - 14 days)

Description: patterns and changes of ROS

Measure: reactive oxygen species (ROS) levels

Time: early stage of disease (first 96 hours)

Description: patterns and changes of ROS

Measure: reactive oxygen species (ROS) levels

Time: mid stage of disease (96 hours - 14 days)

Description: patterns and changes of ROS

Measure: reactive oxygen species (ROS) levels

Time: late stage of disease (>14 days)

Description: patterns and changes of the most important coagulation factors (i.e. tissue factor antigen pg/dL)

Measure: coagulation factors levels

Time: early stage of disease (first 96 hours)

Description: patterns and changes of the most important coagulation factors (i.e. tissue factor antigen pg/dL)

Measure: coagulation factors levels

Time: mid stage of disease (96 hours - 14 days)

Description: patterns and changes of the most important coagulation factors (i.e. tissue factor antigen pg/dL)

Measure: coagulation factors levels

Time: late stage of disease (>14 days)

Description: values of FEV1% as assessed by spirometry

Measure: respiratory function

Time: 6-month

Description: values of FEV1% as assessed by spirometry

Measure: respiratory function

Time: 12-month

Description: values of left ventricular ejection fraction as assessed by transthoracic echocardiogram

Measure: cardiac function

Time: 6-month

Description: values of left ventricular ejection fraction as assessed by transthoracic echocardiogram

Measure: cardiac function

Time: 12-month

Description: occurrence of death, myocardial infarction, stroke and other major adverse events

Measure: clinical outcome

Time: 12-month

208 Convalescent Plasma in the Treatment of COVID 19

The purpose of this study is to collect blood from previously COVID-19 infected persons who have recovered and use it as a treatment for those who are currently sick with a severe or life-threatening COVID-19 infection.

NCT04343261 SARS-CoV-2 COVID Coronavirus Biological: Convalescent Plasma

MeSH:Coronavirus Infections

Primary Outcomes

Description: Mortality within 28 days

Measure: Mortality

Time: 28 days

Description: Reduction of Viral Load ]

Measure: Viral Load

Time: 7 days

Description: Change in Serum Antibody Titers

Measure: Serum Antibody Titers

Time: 7 days

209 A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate Coronavirus Disease 2019 (COVID-19)

This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection.

NCT04343651 Coronavirus Disease 2019 Drug: Placebos Drug: Leronlimab (700mg)

MeSH:Coronavirus Infections

Primary Outcomes

Description: Note: The total score per patient ranges from 0 to 12 points. Each symptom is graded from 0 to 3. [0=none, 1=mild, 2=moderate, and 3=severe]. Higher scores mean a worse outcome.

Measure: Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough)

Time: Day 14

Secondary Outcomes

Measure: Time to clinical resolution (TTCR)

Time: Day 14

Description: This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). Higher scores mean a worse outcome.

Measure: Change from baseline in National Early Warning Score 2 (NEWS2)

Time: Days 3, 7, and 14

Measure: Change from baseline in pulse oxygen saturation (SpO2)

Time: Days 3, 7, and 14

Description: A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities. Lower scores mean a worse outcome.

Measure: Change from baseline in the patient's health status on a 7-category ordinal scale

Time: Days 3, 7, and 14

Measure: Incidence of hospitalization

Time: Day 14

Measure: Duration (days) of hospitalization

Time: Day 14

Measure: Incidence of mechanical ventilation supply

Time: Day 14

Measure: Duration (days) of mechanical ventilation supply

Time: Day 14

Measure: Incidence of oxygen use

Time: Day 14

Measure: Duration (days) of oxygen use

Time: Day 14

Measure: Mortality rate

Time: Day 14

Measure: Time to return to normal activity

Time: Day 14

Other Outcomes

Measure: Change in size of lesion area by chest radiograph or CT

Time: Day 14

Measure: Change from baseline in serum cytokine and chemokine levels

Time: Days 3, 7, and 14

Measure: Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages

Time: Days 3, 7, and 14

Measure: Change from baseline in CD3+, CD4+ and CD8+ T cell count

Time: Days 3, 7, and 14

210 Efficacy of Injectable Methylprednisolone Sodium Succinate in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome Under the New Coronavirus (SARS-CoV2): a Phase IIb, Randomized, Double-blind, Placebo-controlled, Clinical Trial.

This is a double-blind, randomized, placebo-controlled, phase IIb clinical trial to assess the efficacy of injectable methylprednisolone sodium succinate (MP) in patients with severe acute respiratory syndrome (SARS) in COVID-19 infection. A total of 416 individuals of both sexes, aged over 18 years old, with symptoms suggestive or confirmed diagnosis of severe acute respiratory syndrome (SARS), hospitalized at the Hospital and Pronto-Socorro Delphina Rinaldi Abdel Aziz (HPSDRAA), with clinical and radiological findings suggestive of SARS-CoV2 infection, will be randomized at a 1:1 ration to receive either MP (0.5mg/kg of weight, twice daily, for 5 days) or placebo (saline solution, twice daily, for 5 days).

NCT04343729 SARS-CoV Infection Severe Acute Respiratory Syndrome (SARS) Pneumonia Drug: Methylprednisolone Sodium Succinate Drug: Placebo solution

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia Syndrome

HPO:Pneumonia

Primary Outcomes

Description: Mortality rate on day 28, after randomization

Measure: Mortality rate at day 28

Time: on day 28, after randomization

Secondary Outcomes

Description: Proportion of patient that died on days 7, 14 and 28.

Measure: Mortality rate on days 7, 14 and 28

Time: after randomization, up to 28 days.

Description: proportion of patients requiring orotracheal intubation

Measure: Incidence of orotracheal intubation

Time: after randomization, up to 7 days.

Description: Proportion of patients with oxygenation index (PaO2 / FiO2) < 100 in 7 days.

Measure: Change in oxygenation index

Time: after randomization, up to 7 days.

211 Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19

Multicenter observational/registry study of the clinical features and outcomes of critically ill patients with COVID-19.

NCT04343898 Coronavirus Infection Other: No intervention

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: 28-Day Mortality

Time: 28-days from the day of ICU admission

Secondary Outcomes

Measure: 60-Day Mortality

Time: 60-days from the day of ICU admission

Measure: 90-Day Mortality

Time: 90-days from the day of ICU admission

Measure: 1-Year Mortality

Time: 1 year from the day of ICU admission

212 COvid-19 and Vitamin D Supplementation: a Multicenter Randomized Controlled Trial of High Dose Versus Standard Dose Vitamin D3 in High-risk COVID-19 Patients (CoVitTrial)

Vitamin D is a secosteroid hormone produced by the skin during Summer exposure to UVB rays. Hypovitaminosis D is common in Winter (October to March) at Northern latitudes above 20 degrees North, and from April to September at Southern latitudes beyond 20 degrees below the equator. In the past, coronaviruses and influenza viruses have exhibited very high seasonality, with outbreaks occurring preferentially during the Winter. The Covid-19 pandemic is indeed more severe above Winter latitudes of 20 degrees, while it remains until now less severe in the Southern hemisphere, with a much lower number of deaths. Preclinical research suggests that the SARS-Cov-2 virus enters cells via the angiotensin converting enzyme 2 (ACE2). Coronavirus viral replication downregulates ACE2, thereby dysregulating the renin-angiotensin system (RAS) and leading to a cytokine storm in the host, causing acute respiratory distress syndrome (ARDS). Research also shows that vitamin D plays a role in balancing RAS and in reducing lung damage. On the contrary, chronic hypovitaminosis D induces pulmonary fibrosis through activation of RAS. Similarly, hypovitaminosis D has been strongly associated in the literature with ARDS, as well as with a pejorative vital prognosis in resuscitation but also in geriatric units, and with various comorbidities associated to deaths during SARS-Cov-2 infections. Conversely, vitamin D supplementation has been reported to increase immunity and to reduce inflammatory responses and the risk of acute respiratory tract infections. High-dose oral vitamin D3 supplementation has been shown to decrease short-term mortality in resuscitation patients with severe hypovitaminosis D (17% absolute risk reduction). It is considered safe to take oral vitamin D supplementation at doses up to 10,000 IU/day for short periods, particularly in older adults, i.e. a population that is mostly affected by hypovitaminosis D and who should receive at least 1,500 IU of vitamin D daily to ensure satisfactory vitamin D status. Vitamin D supplementation is mentioned as a potentially interesting treatment for SARS-Cov-2 infection but on a scientific basis with a low level of evidence until now. We hypothesize that high-dose vitamin D supplementation improves the prognosis of older patients diagnosed with COVID-19 compared to a standard dose of vitamin D.

NCT04344041 Coronavirus Drug: cholecalciferol 200,000 IU Drug: cholecalciferol 50,000 IU

MeSH:Coronavirus Infections

Primary Outcomes

Measure: Number of death of any cause, during the 14 days following the inclusion and intervention.

Time: Day 14

Secondary Outcomes

Measure: Number of death of any cause, during the 28 days following the inclusion and intervention.

Time: Day 28

Description: OSCI ranges from 0 to 8, higher score meaning poorer outcome

Measure: Clinical evolution between day 0 and day 14 based on the change of the WHO Ordinal Scale for Clinical Improvement (OSCI) for COVID-19

Time: Day 14

Description: OSCI ranges from 0 to 8, higher score meaning poorer outcome

Measure: Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19

Time: Day 28

Measure: Rate of patients with at least one severe adverse event at day 28, according to the regulations

Time: Day 28

Measure: Number of death of any cause during the 14 days following the inclusion and intervention, in patients with severe hypovitaminosis D (25-OHD <25nmol/L) at baseline

Time: Day 14

Measure: Number of death of any cause during the 28 days following the inclusion and intervention, in patients with severe hypovitaminosis D (25-OHD <25nmol/L) at baseline

Time: Day 28

Description: OSCI ranges from 0 to 8, higher score meaning poorer outcome

Measure: Clinical evolution between day 0 and day 14 based on the change of the OSCI for COVID-19, in patients with severe hypovitaminosis D (25-OHD <25nmol/L) at baseline

Time: Day 14

Description: OSCI ranges from 0 to 8, higher score meaning poorer outcome

Measure: Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19, in patients with severe hypovitaminosis D (25-OHD<25nmol/L) at baseline

Time: Day 28

Measure: Number of death of any cause during the 14 days following the inclusion and intervention, depending on serum vitamin D concentration achieved at day 7 (25-OHD<75nmol/L or 25-OHD≥75nmol/L)

Time: Day 14

Measure: Number of death of any cause during the 28 days following the inclusion and intervention, depending on serum vitamin D concentration achieved at day 7 (25-OHD<75nmol/L or 25-OHD≥75nmol/L)

Time: Day 28

Description: OSCI ranges from 0 to 8, higher score meaning poorer outcome

Measure: Clinical evolution between day 0 and day 14 based on the change of the OSCI for COVID-19, depending on serum vitamin D concentration achieved at day 7 (25-OHD<75nmol/L or 25-OHD≥75nmol/L)

Time: Day 14

Description: OSCI ranges from 0 to 8, higher score meaning poorer outcome

Measure: Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19, depending on serum vitamin D concentration achieved at day 7 (25-OHD<75nmol/L or 25-OHD≥75nmol/L)

Time: Day 28

Measure: Number of death of any cause during the 14 days following the inclusion and intervention, in patients with severe hypovitaminosis D (25-OHD<25nmol/L) at day 0, depending on serum vitamin D concentration achieved at day 7 (<75nmol/L or ≥75nmol/L)

Time: Day 14

Measure: Number of death of any cause during the 28 days following the inclusion and intervention, in patients with severe hypovitaminosis D (25-OHD<25nmol/L) at day 0, depending on serum vitamin D concentration achieved at day 7 (<75nmol/L or ≥75nmol/L)

Time: Day 28

Description: OSCI ranges from 0 to 8, higher score meaning poorer outcome

Measure: Clinical evolution between day 0 and day 14 based on the change of the OSCI for COVID-19, in patients with severe hypovitaminosis D (25-OHD<25nmol/L) at day 0, depending on serum vitamin D concentration achieved at day 7 (<75nmol/L or ≥75nmol/L)

Time: Day 14

Description: OSCI ranges from 0 to 8, higher score meaning poorer outcome

Measure: Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19, in patients with severe hypovitaminosis D (25-OHD<25nmol/L) at day 0, depending on serum vitamin D concentration achieved at day 7 (<75nmol/L or ≥75nmol/L)

Time: Day 28

Measure: Number of death of any cause during the 14 days following the inclusion and intervention, depending on evolution of serum vitamin D concentration between day 0 and day 7

Time: Day 14

Measure: Number of death of any cause during the 28 days following the inclusion and intervention, depending on evolution of serum vitamin D concentration between day 0 and day 7

Time: Day 28

Description: OSCI ranges from 0 to 8, higher score meaning poorer outcome

Measure: Clinical evolution between day 0 and day 14 based on the change of the OSCI for COVID-19, depending on evolution of serum vitamin D concentration between day 0 and day 7

Time: Day 14

Description: OSCI ranges from 0 to 8, higher score meaning poorer outcome

Measure: Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19, depending on evolution of serum vitamin D concentration between day 0 and day 7

Time: Day 28

Measure: Number of death of any cause during the 14 days following the inclusion and intervention, compared to mortality data in French hospital geriatric units from the current national survey by the French Society of Geriatrics and Gerontology

Time: Day 14

213 Prone Positioning in Spontaneously Breathing Nonintubated Covid-19 Patient: a Pilot Study (ProCov)

The prone position consists of placing the patient on his or her stomach with the head on the side, during sessions lasting several hours a day and could help spontaneous ventilate the patient.

NCT04344106 Coronavirus Infection Oxygen Deficiency Procedure: Prone positioning

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Hypoxia

HPO:Hypoxemia

Primary Outcomes

Description: PaO2 improvement of more than 20% after one hour in prone position in spontaneously breathing non intubated COVID-19 patients.

Measure: Proportion of "responder" patients to prone position

Time: 1 hour

Secondary Outcomes

Description: PaO2 improvement of more than 20% at 6 to 12 hours from return to supine position.

Measure: proportion of "persistent responders" patients after prone position

Time: 1 day

Description: PaO2 at 1 hour from the start of prone position and at 6 to 12 hours afterreturn to supine position.

Measure: Evolution of PaO2

Time: 1 day

Description: Look for an association between the time spent in Prone positione and persistent responder or not;

Measure: Duration of prone positioning and PaO2 evolution

Time: 2 days

Description: proportion of patients improving their arterial saturation within 1 hour of Prone Position

Measure: Evolution of Spo2

Time: 1 hour

Description: evolution of the EVA scores for dyspnea at 1 hour from the start of the Prone Position and at 6 hours after the end of the Prone Position

Measure: EVA Dyspnea

Time: 1 day

Description: proportion of patients intolerant to prone position (Prone Position <1h);

Measure: Intolerance to prone positioning

Time: 1 day

Description: proportion of patients who can maintain prone position for more than 3 h.

Measure: Tolerance to prone positioning

Time: 1 day

214 A Pilot Study for Collection of Anti-SARS-CoV-2 Immune Plasma

Background: The human disease caused by SARS-CoV-2 is called COVID-19. In most cases, COVID-19 is a mild to moderate respiratory illness. But it can also be more severe and even lead to death. There is no vaccine to prevent SARS-CoV-2 infection. There is also no therapy to treat COVID-19. Researchers want to collect plasma from adults who have recovered from COVID-19, which may help them develop treatments. Objective: To collect anti-SARS-CoV-2 immune plasma from adult volunteers who have recovered from COVID-19. Eligibility: Males and females ages 18 to 70 who have a history of COVID-19 like illness or positive test for SARS-CoV-2, and have a minimum level of SARS-CoV-2 antibodies as specified by the study. Design: This study consists of 2 parts: 1) screening for SARS-CoV-2 antibody titer and eligibility to donate plasma and 2) plasma collection by apheresis. Study sites may participate in 1 part alone (either screening or plasma collection only) or both parts (screening and plasma collection). For screening part: Participants will be screened for their eligibility to join this research study with a medical history and physical exam. Their vital signs (blood pressure, heart rate, temperature, respiration rate) will be taken. Their weight and height will be recorded. They will give a blood sample for clinical laboratory tests of their general health and a research test for SARS-CoV-2 antibodies. They will discuss their history of COVID-19-like illness and any testing for SARS-CoV-2. They will be evaluated for their ability to donate plasma. For plasma collection part: Subjects meeting criteria for plasma donation and found to have high neutralizing antibody titers and who plan to donate plasma under this part of the study will be scheduled for 1 (and up to 20) plasma collection sessions. These will occur no less than 7 days apart. Prior to each donation, participants will have a brief physical exam and complete a donor history questionnaire. They will be asked about any current SARS-CoV-2 infection symptoms. At each donation, plasma will be taken through a standard apheresis procedure. For this, blood will be withdrawn through a needle placed in the participant's arm vein. A machine will separate the plasma from the red cells. The red cells will be returned to the participant, either through the same needle or through a second needle in the other arm. Participation may last up to 240 days.

NCT04344977 Cor Coronavirus Disease 2019 (COVID-19)

MeSH:Coronavirus Infections

Primary Outcomes

Description: Donors screened and identified and anti-SARS-CoV-2 immune plasma collected

Measure: Identification of eligible donors and collection of anti-SARS-CoV-2 immune plasma

Time: Screening, Days 120 or 240

215 Efficacy and Safety of Treatment With Convalescent Plasma for Adults With COVID-19 Pneumonia. A Double-blinded, Randomized, Multicenter Placebo-controlled Trial

CCAP is an investigator-initiated multicentre, randomized, double blinded, placebo-controlled trial, which aims to assess the safety and efficacy of treatment with convalescent plasma for patients with moderate-severe COVID-19. Participants will be randomized 2:1 to two parallel treatment arms: Convalescent plasma, and intravenous placebo. Primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days.

NCT04345289 COVID Corona Virus Infection Viral Pneumonia Biological: Convalescent anti-SARS-CoV-2 plasma Other: Infusion placebo

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: Composite outcome

Measure: All-cause mortality or need of invasive mechanical ventilation

Time: 28 days

Secondary Outcomes

Description: Number of participants with adverse events with possible relation to study drug

Measure: Frequency of adverse events

Time: 90 days

Description: Number of participants with serious adverse events according to International Council of Harmonisation-Good Clinical Practice (ICH-GCP) guidelines

Measure: Frequency of severe adverse events

Time: 90 days

Description: Number of days to improvement of at least 2 categories relative to baseline on the ordinal scale. Categories are as follows: Death; Hospitalized, in intensive care requiring Extracorporeal Membrane Oxygenation (ECMO) or mechanical ventilation; Hospitalized, on non-invasive ventilation or high-flow oxygen device; Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities

Measure: Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status

Time: 90 days

Description: Number of days without mechanical ventilation

Measure: Ventilator-free days

Time: 28 days

Description: Number of days without organ-failure

Measure: Organ failure-free days

Time: 28 days

Description: Number of days in ICU

Measure: Duration of ICU stay

Time: 90 days

Description: Number of deaths by any cause

Measure: Mortality rate

Time: 7, 14, 21, 28 and 90 days

Description: Days from the date of hospital admission for COVID-19 to the date of discharge

Measure: Length of hospital stay

Time: 90 days

Description: Days requiring supplement oxygen

Measure: Duration of supplemental oxygen

Time: 90 days

216 Randomized Trial Assessing Efficacy and Safety of Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for Hospitalized Adults With COVID-19 Pneumonia

Double blinded randomized clinical trial designed to evaluate the efficacy and safety of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in patients hospitalized with confirmed COVID-19 pneumonia.

NCT04345861 Coronavirus Infection Pneumonia, Viral Drug: Hydroxychloroquine + placebo Drug: hydroxychloroquine + azithromycin

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: Evaluation of the clinical status of patient defined by the Ordinal Scale of 7 points (score range from 1 to 7 , with 7 being the worst score)

Measure: Time to clinical improvement of at least 1 level on the ordinal scale between Day 1 (day of the first administration of study drug) to Day 11 (day after last day of treatment).

Time: up to Day 11

Secondary Outcomes

Description: Evaluation of the clinical status of patient defined by the Ordinal Scale of 7 points at day 15 and day 29

Measure: Clinical status assessed by ordinal scale

Time: up to Day 29

Description: Necessity for transfer to Intensive care unit

Measure: transfer to ICU

Time: up to Day 29

Description: days from admission to hospital discharge

Measure: Length of hospital day

Time: up to Day 29

Description: incidence of all-cause mortality

Measure: Hospital Mortality

Time: Day 29

Description: Need to mechanical ventilation

Measure: Need to Mechanical Ventilation

Time: up to Day 29

Description: adverse reactions

Measure: Occurence of grade 3-4 adverse event

Time: up to Day 29

Description: ECG

Measure: QTc Lengthening

Time: up to Day 11

Description: Thoracic CT scan : number and size of ground-glass opacifications on day 1 and day 11 Two independent pulmonary imagery experts will assess abnormalities according to a standardized framework

Measure: Evolution of pulmonary CT scan images

Time: up to Day 11

217 Strain Study: To Access the Egyptian COVID-19 Whole Genome (Dominant Strain) by Next Generation Sequencing (NGS) and Compare to the International Worldwide Database

This is an exploratory study that will be performed on confirmed positive COVID-19 samples to identify the dominant viral genome strain in Egyptians using next generation sequencing (NGS).

NCT04346043 Coronavirus Disease (COVID-19)

MeSH:Coronavirus Infections

Primary Outcomes

Description: Identify the dominant viral genome strain in Egyptians With COVID-19 infection using next generation sequencing (NGS)

Measure: Dominant viral genome strain

Time: 9 months

218 Retrospective Study From November 2019 -Febrauary 2020 on Severe Respiratory Illness to Access the Presence or Absence of COVID-19 in Patients Samples by Real-time PcR

Retrospective study from November 2019 -Febrauary 2020 on severe respiratory illness to access the presence or absence of COVID-19 in patients samples by real-time PcR

NCT04346056 Coronavirus Disease (COVID-19) COVID-19

MeSH:Coronavirus Infections

Primary Outcomes

Description: Exploring the presence of COVID-19 in very well preserved oropharyngeal samples since November 2019

Measure: Exploring the presence of COVID-19

Time: 9 months

219 Safety and Efficacy of Intravenous Infusion of Bone Marrow-Derived Mesenchymal Stem Cells in Severe Patients With Coronavirus Disease 2019 (COVID-19): A Phase 1/2 Randomized Controlled Trial

Coronavirus Disease 2019 (COVID-19) is spreading worldwide and has become a public health emergency of major international concern. Currently, no specific drugs or vaccines are available. For severe cases, it was found that aberrant pathogenic T cells and inflammatory monocytes are rapidly activated and then producing a large number of cytokines and inducing an inflammatory storm.Mesenchymal stem cells (MSCs) have been shown to possess a comprehensive powerful immunomodulatory function. This study aims to investigate the safety and efficacy of intravenous infusion of mesenchymal stem cells in severe patients with COVID-19.

NCT04346368 Coronavirus Disease 2019 (COVID-19) Biological: BM-MSCs Biological: Placebo

MeSH:Coronavirus Infections

Primary Outcomes

Description: Evaluation of pneumonia improvement

Measure: Changes of oxygenation index (PaO2/FiO2)

Time: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.

Description: Proportion of participants with treatment-related adverse events

Measure: Side effects in the BM-MSCs treatment group

Time: Baseline through 6 months

Secondary Outcomes

Description: Improvement of clinical symptoms including duration of fever, respiratory destress, pneumonia, cough, sneezing, diarrhea.

Measure: Clinical outcome

Time: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.

Description: days of the patients in hospital

Measure: Hospital stay

Time: Baseline through 6 months

Description: Evaluation of pneumonia improvement

Measure: CT Scan

Time: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.

Description: (deep sputum / pharyngeal swab / nasal swab / anal swab / tear fluid / stomach fluid / feces / blood or alveolar lavage fluid)

Measure: Changes in viral load

Time: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.

Description: Immunological status

Measure: Changes of CD4+, CD8+ cells count and concentration of cytokines

Time: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.

Description: Marker for efficacy

Measure: Rate of mortality within 28-days

Time: From baseline to day 28

Description: Markers of Infection

Measure: Changes of C-reactive protein

Time: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.

220 A Pilot Study to Explore the Efficacy and Safety of Rescue Theraphy With Antibodies From Convalescent Patients Obtained With Double -Filtration Plasmapheresis (DFPP) and Infused in Critically Ill Ventilated Patients With Coronavirus Disease 2019 (COVID-19)

The 2019 outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 or COVID 19), which originated in Wuhan, China, has become a major concern all over the world. Convalescent plasma or immunoglobulins have been used as a last resort to improve the survival rate of patients with SARS whose condition continued to deteriorate despite any attempted treatment.. Moreover, several studies showed a shorter hospital stay and lower mortality in patients treated with convalescent plasma than those who were not treated with convalescent plasma. Evidence shows that convalescent plasma from patients who have recovered from viral infections can be used effectively as a treatment of patients with active disease. The use of solutions enriched of antiviral antibodies has several important advantages over the convalescent plasma including the high level of neutralizing antibodies supplied. Plasma-exchange is expensive and requires large volumes of substitution fluid. Albumin is better tolerated and less expensive, but exchanges using albumin solutions increase the risk of bleeding because of progressive coagulation factor depletion. With either albumin or fresh frozen plasma, increasing the risk of cardiovascular instability in the plasma donor and in the recipient, which can be detrimental in a critically ill patient with COVID 19 pneumonia. The aforementioned limitations of plasma therapy can be overcome by using selective apheresis methods, such as double-filtration plasmapheresis (DFPP).DFPP is a modality of plasma purification that performs an initial plasma separation from blood, and the subsequent separation of specific molecules, on the basis of their specific molecular weight (cut-off), by using a fractionation filter. The Fractionation Filter 2A20, because of its membrane sieving cut-off, retains larger molecules and returns plasma along with smaller molecules to the circulation, including the major part of the albumin. The selection of the membrane 2A20 is related to the appropriate Sieving Coefficient for IgG that allows to efficiently collect antibodies from patients which are recovered from COVID-19, with negligible fluid losses and limited removal of albumin. The total amount of antibodies obtained during one DFPP session exceeds by three to four times the total amount provided to recipients with one unit of plasma obtained during one plasma-exchange session from one COVID-19 convalescent donor. This should result in more effective viral inhibition and larger benefit for the patient achieved with one unit of enriched immunoglobulin solution obtained with DFPP than with one unit of plasma obtained with plasma exchange. These observations provide the background for a pilot study aimed to explore whether the infusion of antibodies obtained with one single DFPP procedure from voluntary convalescent donors could offer an effective and safe therapeutic option for critically ill patients with severe coronavirus (COVID-19) pneumonia requiring mechanical ventilation.

NCT04346589 Pneumonia, Ventilator-Associated Coronavirus Infection Biological: Anti-coronavirus antibodies (immunoglobulins)obtained with DFPP from convalescent patients

MeSH:Pneumonia, Ventilator-Associated Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia

HPO:Pneumonia

Primary Outcomes

Measure: Number of mechanical ventilation days.

Time: Through study completion, an average of 6 months.

Secondary Outcomes

Measure: Survival

Time: Through study completion, an average of 6 months.

Measure: Shift to Continuous Positive Airway Pressure (CPAP) ventilation

Time: Through study completion, an average of 6 months.

Measure: Referral to a sub-intensive care unit or discharge

Time: Through study completion, an average of 6 months.

Measure: Viral titer

Time: Changes from before Ig administration, one day and one week after Ig administration and every week after discharge from the intensive care unit through study completion, an average of 6 months.

Measure: Anti COVID 19 IgG antibodies

Measure: Anti COVID 19 IgM antibodies

Description: Marker of complement activation in plasma.

Measure: C5a concentration

Description: Marker of complement activation in plasma.

Measure: C3a concentration

Description: Marker of complement activation in plasma.

Measure: Serum C5b-9 concentration

221 Use and Dosage of Hydroxychloroquine and Chloroquine to Convert Real Time Polymerase Chain Reaction (RT-PCR) Positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Coronavirus Infectious Disease 2019 (COVID-19) Patients to RT- PCR-Negative as a Means to Reduce Hospitalization Rate

To create a protocol for treatment of Pakistani patients with SARS-CoV-2 infection with an intent to reduce burden on institutional healthcare services by determining efficacy of different quinone drug dosing regimens in controlling SARS-CoV-2 infection for asymptomatic patients.

NCT04346667 SARS-CoV-2 Coronavirus Infection Asymptomatic Condition COVID-19 Drug: Hydroxychloroquine Sulfate Regular dose Drug: Hydroxychloroquine Sulfate Loading Dose Drug: Chloroquine Drug: Placebo

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Asymptomatic Diseases

Primary Outcomes

Description: Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7

Measure: RT-PCR negative status

Time: 6-7 days

Secondary Outcomes

Description: Time to progression to next stage of SARS-CoV-2 disease severity index

Measure: Progression of symptoms

Time: 7 days

Description: Time to onset of fever (temperature greater than 100 degree F), cough, or shortness of breath (respiratory rate >22 per minute).

Measure: Development of Symptoms

Time: 7 days

Description: Drug related adverse events as determined by data safety and monitoring board (DSMB)

Measure: Adverse events

Time: 7 days

222 Investigation of the Effects of Exercise Using Telerehabilitation in Patients Diagnosed With Coronavirus (COVID-19) and Followed at Home

In December 2019, new coronavirus pneumonia (COVID-19) erupted in Wuhan (Hubei, China) and quickly spread from a single city to the entire country. It did not take long for this epidemic to spread to the world. After that, World Health Organization declared this epidemic disease as a pandemic. As of now, the number of coronavirus deaths increased to 108,281 worldwide. Total number of cases approached 1,800,000 according to the latest information. While the number of healed patients was highest in China, 77,525 people with COVID-19 recovered. COVID-19 is a highly contagious respiratory infectious disease that can cause respiratory, physical and psychological dysfunction in patients. Respiratory rehabilitation reduces the patient's symptoms of dyspnea, relieves anxiety and depression, reduces the patient's need to apply to the hospital, increases functional capacity and improves the patient's quality of life. Respiratory rehabilitation, according to the feedback from China, is very important for patients in the clinical treatment and recovery process after treatment. Rehabilitation of people with mild disease after discharge is mainly based on improving physical fitness and psychological adaptation. It is also aimed to gradually restore the individual's ability to the activity before the disease and return to the community as soon as possible. Individuals with COVID-19 who have respiratory and / or limb dysfunction and chronic disease after discharge should receive respiratory rehabilitation therapy. According to the current findings of the patients discharged from severe acute respiratory syndrome (SARS-CoV) and Middle East respiratory syndrome (MERS) and the clinical experience of patients with Acute Respiratory Distress Syndrome (ARDS) patients who recovered after discharge, COVID-19 patients may have physical fitness, dyspnea after activity, and muscle atrophy. (Including respiratory muscles and trunk muscles) It is recommended to use respiratory videos and booklets as the main method for respiratory rehabilitation in isolated patients at home. Telerehabilitation method is also a different recommendation option for rehabilitation. The purpose of this study is to investigate the effects of exercises performed by telerehabilitation in patients diagnosed with COVID-19 followed at home. It is aimed to use an innovative model based on the digitally supported, home-based exercise program.

NCT04346927 Telerehabilitation Coronavirus Other: Telerehabilitation Other: exercise brochure

MeSH:Coronavirus Infections

Primary Outcomes

Description: Visual Analogue Scale (VAS) is a horizontal line, 100 mm in length, and anchored by word descriptors at each end. The VAS dyspnea score uses "no shortness of breath at all" and "maximum shortness of breath" . The patient marks on the line the point that they feel represents the perception of their current state. The distance (mm) between the beginning of the horizontal line and this mark represents the degree of dyspnea perception

Measure: Visual Analogue Scale

Time: 2 weeks

Description: This scale used was a modified Borg scale of perceived exertion adapted to be appropriate for measuring fatigue. This consisted of a vertical scale labelled 0-10, with corresponding verbal expressions of progressively increasing perceived sensation intensity. (0 = no fatigue , 10 = maximal fatigue)

Measure: Modified Borg Scale

Time: 2 weeks

Description: Leicester Cough Questionnaire (LCQ) is an English-born self-reporting quality of life measure of chronic cough. It consists of 19 items with a 7 point likert response scale (range from 1 to 7). Each item is developed to assess symptoms during cough and impact of cough on three main domains: physical, psychological and social. Scores are calculated as a mean of each domain and the total score is calculated by adding every domain score. It generally takes about 5 minutes to be completed and it is designed for adults

Measure: Leicester Cough Questionnaire

Time: 2 weeks

Description: The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require

Measure: Timed Up and Go

Time: 2 weeks

Description: The 30-s Chair Stand Test consists of standing up and sitting down from a chair as many times as possible within 30 seconds. A standard chair without backrest, but with armrests is used. Initially, the person is seated on the chair with his backs upright. They are told to look forward with their arms folded in their chest and rise at their preferred speed after the command "1, 2, 3, go". All trials must be carried out using the same chair and similar environmental conditions.

Measure: 30 Second Chair Stand Test

Time: 2 weeks

Description: The Beck Depression Inventory (BDI) is a 21-item, self-rated scale that evaluates key symptoms of depression. Individual scale items are scored on a 4-point continuum (0=least, 3=most), with a total summed score range of 0-63. Higher scores indicate greater depressive severity. Two subscales include a cognitive-affective subscale and a somatic-performance subscale

Measure: The Beck Depression Inventory

Time: 2 weeks

Description: The Beck Anxiety Inventory (BAI) is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults.The questions used in this measure ask about common symptoms of anxiety . It is designed for individuals who are of 17 years of age or older and takes 5 to 10 minutes to complete. Several studies have found the Beck Anxiety Inventory to be an accurate measure of anxiety symptoms in children and adults

Measure: The Beck Anxiety Inventory

Time: 2 weeks

223 Investigation Of The Effectiveness Of Video-Based Exercise Program Applied To Adult Individuals Who Experience Social Isolation At Houses Due To The Coronavirus (COVID-19) Pandemic

In December 2019, new coronavirus pneumonia (COVID-19) broke out in Wuhan (Hubei, China), and it spread rapidly from one city to the whole country in just 30 days, and then worldwide cases began to appear. All the countries of the world take some precautions to prevent the spread of this epidemic disease, which WHO declared as "pandemic". Apart from compulsory situations, non-home and social isolation are the primary measures. However, not leaving the house and social isolation brings with it the restriction of physical activity. According to World Health Organization (WHO), in order to obtain health benefits, adult individuals between the ages of 18-64 should perform at least 150 minutes of physical activity per week (30 minutes a day for 5 days a week) or intensive physical activity for at least 75 minutes a week. For additional health benefits, adults should increase their moderate-intensity physical activities to at least 300 minutes a week or equivalent. Physical activity; It is directly related to the prevention of chronic diseases, increasing fitness, strengthening the muscles and increasing the quality of life. It is reported that one of the ten main risk factors in terms of mortality in the world is insufficient physical activity. The effects of social isolation are related to physical inactivity, smoking and the possibility of having both health risk behaviors together. Practical and innovative interventions are needed to reduce physical performance and decrease in muscle mass, strength and physical performance in the aging population. Considering today's conditions and current COVID-19 Pandemic, technology-supported exercise programs are effective in increasing the motivation for physical activity. The purpose of this study; In order to prevent the spread of the COVID-19 pandemic, social isolation, which is one of the measures taken in our country, is to evaluate the physical activity level of adults and to investigate the effectiveness of home exercises. It is aimed to use a model based on the video supported by a home-based exercise program.

NCT04346953 Healthy Lifestyle Behavioral: Video based exercise

MeSH:Coronavirus Infections

Primary Outcomes

Description: The International Physical Activity Questionnaire -Short Form (IPAQ-SF) measures the frequency and duration of moderate physical activity, vigorous physical activity, walking, and sedentary behavior using 7 questions and is considered more suitable for population surveillance and large-scale studies compared with the long form . The IPAQ-SF was validated for adults.According to the score obtained, the physical activity levels of individuals are determined. It indicates lower physical activity level below 600 Metabolic Equivalent Threshold (MET)-min per week, medium physical activity level between 600-3000 Metabolic Equivalent Threshold (MET)-min per week and high physical activity level between 600-3000 Metabolic Equivalent Threshold (MET)-min per week.

Measure: International Physical Activity Questionnaire - Short Form

Time: 2 weeks

Measure: Nottingham Health Profile

Time: 2 weeks

Description: It is among the most used scales to measure depression all over the world. It consists of 21 questions in total. Each item gets points between 0-3. 11-17 points indicate mild depression, 18-29 points indicate moderate depression, and 30-63 points indicate severe depression.

Measure: Beck Depression Inventory

Time: 2 weeks.

Description: It is used to evaluate the anxiety symptoms experienced by individuals due to social isolation. It consists of 21 items and is scored between 0-3. It indicates low anxiety of 0-21 points, moderate anxiety of 22-35 points and high anxiety of 36 points and above.

Measure: Beck Anxiety Inventory

Time: 2 weeks

Description: It is a scale that provides information about sleep quality and type and severity of sleep disorder in the last month. The sleep quality of the person on this scale; sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, sleep medication use and daytime dysfunction. Each question is given a score of 0-3. High scores reflect poor sleep quality. If the total score obtained from the scale is less than 5, it is defined as "Good sleep quality" and 5 and above is defined as "Bad sleep quality".

Measure: Pittsburgh Sleep Quality Index

Time: 2 weeks

Description: Used for mobility assessment. The test begins while the person is sitting in the chair. The person is asked to get up from the chair, walk 3 meters, come back and sit on the chair again, and the time is recorded. If an elderly person completes the test for more than 12 seconds, there is a risk of falling.

Measure: Timed Get Up and Go Test

Time: 2 weeks

Description: Flamingo Balance Test will be used to evaluate the static balance of the individuals who will participate in the study. This test is done on one foot. While individuals are in balance with one foot, time begins and tries to stay in balance for 1 minute. The time is stopped when the balance is disturbed. When the time is completed, each individual attempt to balance is counted and this number is recorded as the individual's score at the end of the test. If the individual tries to balance 15 times in the first 30 seconds, the test is stopped and zero points are given.

Measure: Flamingo Balance Test

Time: 2 weeks

224 A Phase 2b/3, Randomized, Double Blind, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19)

The purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injection in subjects with severe or critical COVID-19 disease.

NCT04347239 Coronavirus Disease 2019 Drug: Placebos Drug: Leronlimab (700mg)

MeSH:Coronavirus Infections

Primary Outcomes

Description: Day 0 refers to the data of randomization/first treatment.

Measure: All-cause mortality at Day 28

Time: Day 28

Secondary Outcomes

Description: Day 0 refers to the data of randomization/first treatment.

Measure: All-cause mortality at Day 14

Time: Day 14

Measure: Change in clinical status of subject at Day 14 (on a 7 point ordinal scale)

Time: Day 14

Measure: Change in clinical status of subject at Day 28 (on a 7 point ordinal scale)

Time: Day 28

Description: The SOFA score assessment will be based on PaO2/FiO2, platelets, Glasgow coma scale (GCS), bilirubin, Mean arterial pressure OR administration of vasoactive agents required, and Serum creatinine

Measure: Change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14.

Time: Day 14

225 The Role of Honey and Nigella Sativa in the Management of COVID-19; A Randomized Controlled, Open-label, Add-on Trial in Lahore, Pakistan

To evaluate the effectiveness of Nigella Sativa (1 gm seed powder in a capsule orally) and 30 ml of honey stirred in 250 ml of distilled water 12 hourly till patient becomes asymptomatic or a maximum of 14 days with standard hospital care versus standard hospital care alone with placebo capsule and 250 ml water, in clearing the COVID-19 nucleic acid from throat and nasal swab, lowering disease detrimental effects on HRCT chest/X-ray and severity of symptoms along with duration of hospital stay till day 14th day of follow up and 30 days mortality (primary outcomes).

NCT04347382 Coronavirus Infection Sars-CoV2 Drug: Honey Drug: Nigella Sativa / Black Cumin Drug: Placebos

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: RT-PCR will be done on admission day (0 day) and then after every 4th day for 14 days or till the symptoms resolved and RT-PCR gets negative. RT-PCR will only be shown as positive or negative (as per limitation of Pakistan).

Measure: Days required to get a positive COVID-19 PCR to negative

Time: upto max 14 days

Description: HRCT will be conducted at admission day (0-day) and a total of maximum four CT-scan will be conducted after every 4th day. The minimum and score at which we label covid-19 positive will be 5 and 25 respectively using internationally standard nomenclature as described by Fleischner Society glossary and peer-reviewed literature on viral pneumonia.

Measure: HRCT/ X-ray findings of disease progression

Time: upto max 14 days

Description: Clinically disease progression will be evaluated depending upon the severity of symptoms being classified as mild, moderate and severe.

Measure: Severity of symptoms progression

Time: upto max 14 days

Description: Duration of hospital stay would be categorized as the number of days the patient stayed in the ward during treatment. The date of admission and date of discharge would give us total duration of stay.

Measure: Duration of Hospital Saty

Time: upto max 14 day

Description: 30 days mortality rate in each arm

Measure: 30 day mortality

Time: 30 days

Secondary Outcomes

Description: every 4th day oxygen saturation at room air will be checked to evaluate the disease progression

Measure: Oxygen Saturation at room air

Time: upto max of 14 days

Description: Involvement of cardiac complications will be assessed

Measure: Incidence of viral myocarditis

Time: upto max 14 days

Description: Lethal complication like ARDS will be assessed to evaluate disease severity

Measure: Incidence of Acute respiratory Distress Syndrome

Time: upto max 14 days

226 Seroprevalence of SARS-Cov-2 Antibodies in Children - a Prospective Multicentre Cohort Study

It is unknown what proportion of healthy children have been exposed to SARS-Cov-2 and how many have antibodies. The aim of this study is to follow a cohort of healthy children over six months and measure their antibodies to SARS-CoV-2.

NCT04347408 COVID Corona Virus Infection Diagnostic Test: Covid-19 Antibody testing (IgG and IgM)

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Immunoglobulins (G and M) to SARS-Cov2 in plasma

Time: 6 months

227 Screening and Risk Assessment of Healthcare Workers and Infection Control in University and COVID-19 Quarantine Hospitals Using Real-time Geospatial Mapping for Emergency Healthcare Resource Mobilization and Management

A prospective investigation and screening of all HCWs working in all governmental university hospitals and the affiliated COVID-19 quarantine hospitals using an online survey and laboratory testing using rapid serological tests and PCR. To date, the Ministry of Higher Education has dedicated quarantine hospitals at the following governmental universities: Ain Shams, Cairo, Helwan, Alexandria, Mansoura, Assiut, Minia. This list may be expanded in the future. The project will be pilot tested in Ain Shams University, then extended to other universities subsequently. For risk categorization of HCWs exposed to COVID-19 virus and assessment of infection control needs, an online survey questionnaire will be administered to all HCWs in the governmental university hospitals involved in emergency and intensive care and in the provision of care for COVID-19 patients in the affiliated COVID-19 quarantine hospitals. For confirmation of infection and determination of the secondary infection rate, paired serological samples at baseline and after exposure will be collected. For measuring the validity of the available rapid serological tests, a respiratory sample will be taken for viral detection by RT-PCR. A real-time interactive map using geographical information system programming will be developed to flag hotspots for HCWs' risk and infection control needs that originated from the online survey risk categorization in governmental university and COVID-19 quarantine hospitals. Policy and decision makers will use the map to manage emergency healthcare resource mobilization based on HCWs' risk and infection control needs.

NCT04348214 Coronavirus Disease (COVID-19)

MeSH:Infection Coronavirus Infections

Primary Outcomes

Description: To determine the risk categorization of HCWs for exposure to a COVID-19 patient using an online survey in governmental university and COVID-19 quarantine hospitals

Measure: Risk categorization of healthcare workers

Time: 9 months

Description: To estimate the COVID-19 infection rate among HCWs in governmental university and quarantine hospitals.

Measure: COVID-19 infection rate among health care workers

Time: 9 months

Description: To determine the risk factors for COVID-19 among health care workers in governmental university and quarantine hospitals.

Measure: Risk factors for COVID-19 among health care workers

Time: 9 months

Description: To evaluate adherence of HCWs to infection prevention and control measures using an online survey in governmental university and COVID-19 quarantine hospitals.

Measure: Adherence of health care workers to infection prevention

Time: 9 months

Description: To determine the validity (sensitivity and specificity) of the available rapid serological test for detecting COVID-19 virus infection among HCWs in governmental university and COVID-19 quarantine hospitals.

Measure: Validity of the available rapid serological test for detecting COVID-19 virus infection

Time: 9 months

Secondary Outcomes

Description: To characterize the risk factors, clinical spectrum, duration and severity of COVID-19 infections among HCWs in governmental university and quarantine hospitals.

Measure: Clinical spectrum of COVID-19

Time: 9 months

Description: To evaluate the effectiveness of infection prevention and control measures programs at health facility level using an online survey tool in governmental university and COVID-19 quarantine hospitals

Measure: Effectiveness of infection prevention in the health care facility

Time: 9 months

Description: To determine the emergency infection prevention and control needs among HCWs using an online survey tool in governmental university and COVID-19 quarantine hospitals

Measure: Emergency infection prevention and control needs

Time: 9 months

Description: To determine the isolation rate among HCWs and the need for emergency HCW replacement in governmental university and COVID-19 quarantine hospitals.

Measure: Isolation rate and emergency health care worker replacement needs

Time: 9 months

Description: To determine the serologic response for HCWs with symptomatic and possibly asymptomatic COVID-19 virus infection in governmental university and COVID-19 quarantine hospitals.

Measure: Rate of seroconversion

Time: 9 months

228 Bacillus Calmette-Guerin Vaccination as Defense Against SARS-CoV-2: A Randomized Controlled Trial to Protect Health Care Workers by Enhanced Trained Immune Responses

SARS-CoV-2 spreads rapidly throughout the world. A large epidemic would seriously challenge the available hospital capacity, and this would be augmented by infection of healthcare workers (HCW). Strategies to prevent infection and disease severity of HCW are, therefore, desperately needed to safeguard continuous patient care. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, and reported morbidity and mortality reductions as high as 70%. Furthermore, in our preliminary analysis, areas with existing BCG vaccination programs appear to have lower incidence and mortality from COVID191. The investigators hypothesize that BCG vaccination can reduce HCW infection and disease severity during the epidemic phase of SARS-CoV-2.

NCT04348370 Coronavirus Coronavirus Infection Coronavirus as the Cause of Diseases Classified Elsewhere Biological: BCG Vaccine Biological: Placebo Vaccine

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary outcome measure is the development of COVID19 infection. We will use the Cox proportional-hazards model to calculate hazard ratios for the development of Covid-19. This will be reported as the proportion of individuals receiving the intervention who are PCR-positive or seroconvert. defined as number of new cases during the 6 month time period

Measure: Incidence of COVID 19 Infection

Time: 6 months

Secondary Outcomes

Description: The secondary outcome measure is disease severity calculated using the Covid Severity Scale Scoring of 0 -10. A score of 10 is worse and a score of 0 is best. Disease severity score will be based on the level of care required for individuals who test positive for COVID19 as follows: non-hospital-based care; patient hospitalized but no oxygen required; hospitalized and oxygen required; patient treated in intensive care and/or on mechanical ventilation; patient died. Additional WHO criteria for severity include severe pneumonia, respiratory failure, acute respiratory distress syndrome, sepsis and septic shock.

Measure: Disease Severity

Time: up to 6 months

229 Randomized Phase II Clinical Trial of Ruxolitinib Plus Simvastatin in the Prevention and Treatment of Respiratory Failure of COVID-19.Ruxo-Sim-20 Clinical Trial.

COVID-19's mechanism to enter the cell is initiated by its interaction with its cellular receptor, the angiotensin-converting enzyme. As a result of this union, a clathrin-mediated endocytosis process begins. This route is one of the therapeutic targets for which available drugs are being investigated in order to treat COVID-19 infection. This is one of the mechanisms blocked by drugs like ruxolitinib and chloroquine. Various drugs approved for clinical use that block the clathrin-mediated endocytosis pathway have been explored. It has been found that the best in vitro and in vivo results were obtained with statins, which also allowed generating a greater potent adaptive immune response. Therefore, statins and specifically simvastatin make it possible to block the entry process used by COVID-19, block inflammation by various mechanisms and increase the adaptive immune response. All of these processes are desirable in patients infected with COVID-19. Statins have been proposed to have beneficial effects in patients infected with MERS-COV, another coronavirus similar to COVID-19, but there have been no randomized studies supporting the use of statins in patients with COVID-19 infection. In this project we propose the combined use of one of these drugs, ruxolitinib with simvastatin, looking for a synergistic effect in the inhibition of viral entry and in the anti-inflammatory effect.

NCT04348695 Coronavirus Infection Drug: Ruxolitinib plus simvastatin Other: Standard of Care

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency

Primary Outcomes

Description: Patients achieving a grade 5 or higher of the WHO 7-point ordinal scale of severity categorization for COVID at day 7 from randomization.

Measure: Percentage of patients who develop severe respiratory failure.

Time: 7 days

Secondary Outcomes

Description: Patients achieving a grade 5 or higher of the WHO 7-point ordinal scale of severity categorization for COVID at day 14 from randomization.

Measure: Percentage of patients who develop severe respiratory failure.

Time: 14 days

Description: Time from ICU admision to ICU discharge.

Measure: Length of ICU stay.

Time: 28 days

Description: Time from hospital admision to hospital discharge.

Measure: Length of hospital stay

Time: 28 days

Description: Percentage of patients alive at 6 months

Measure: Survival rate at 6 months

Time: 6 months

Description: Percentage of patients alive at 12 months

Measure: Survival rate at 12 months

Time: 12 months

Description: Percentage of patients who died from any cause 28 days after inclusion in the study

Measure: Survival rate at 28 days

Time: 28 days

Description: Percentage of patients with each AE by grade in relation with total number of treated patients

Measure: Percentage of patients with each AE by grade

Time: 28 days

Description: Percentage of patients who discontinued due to AEs in relation with total number of treated patients

Measure: Percentage of patients who discontinued due to AEs

Time: 28 days

230 Plasma Rich Antibodies From Recovered Patients From COVID19

Prospective interventional study, single arm of purified convalescent plasma transfusion as an add on therapy for the standard of care treatment (national guideline) (Oseltamivir (75mg/12 hours for 5-10 days) and hydroxychroquine (400mg twice in first day, 200 twice for 4-9 days) ± Azithromycin 500mg daily for 5 days

NCT04348877 Coronavirus Disease (COVID-19) Other: Antibody-Rich Plasma from COVID-19 recovered patients

MeSH:Coronavirus Infections

Primary Outcomes

Description: Two successive negative COVID-19 PCR analysis tests 72 hours apart

Measure: viral COVID-19 clearance

Time: 14 days

Secondary Outcomes

Description: The percentage of decrease of radiological abnormalities at day 14

Measure: Decrease of radiological abnormalities

Time: 14 days

Description: Clinical improvement in form of normal body temperature for 48 hours

Measure: Clinical improvement

Time: 14 days

231 A Phase 2 Randomized Single-Blind Study to Evaluate the Activity and Safety of Low Dose Oral Selinexor (KPT-330) in Patients With Severe COVID-19 Infection

The main purpose of this study is to evaluate the activity of low dose oral selinexor (KPT-330) and to evaluate the clinical recovery, the viral load, length of hospitalization and the rate of morbidity and mortality in participants with severe COVID-19 compared to placebo.

NCT04349098 Coronavirus Infection Drug: Selinexor Other: Placebo

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Percentage of Participants with at Least a 2 Point Improvement in the Ordinal Scale

Time: Baseline to Day 14

Secondary Outcomes

Measure: Time to Clinical Improvement (TTCI)

Time: Up to Day 28

Measure: Overall Death Rate

Time: Day 14, Day 28

Measure: Rate of Mechanical Ventilation

Time: Up to Day 28

Measure: Time to Mechanical Ventilation

Time: Up to Day 28

Measure: Overall Survival

Time: Up to Day 28

Measure: Time to Improvement (2 points) in Clinical Measures Using the Ordinal Scale

Time: Baseline, Day 28

Measure: Time to Intensive Care Unit (ICU) Admission

Time: Up to Day 28

Measure: Rate of Intensive Care Unit (ICU) Admission

Time: Up to Day 28

Measure: Length of Stay in Hospital

Time: Up to Day 28

Measure: Percentage of Participants Discharged from Hospital

Time: Up to Day 28

Measure: Length of Stay in Intensive Care Unit (ICU)

Time: Up to Day 28

Measure: Duration of Oxygen Supplementation

Time: Up to Day 28

Measure: Duration of Mechanical Ventilation

Time: Up to Day 28

Measure: Time to Clinical Improvement in Participants ≤ 70 Years Old

Time: Up to Day 28

Measure: Time to Clinical Improvement in Participants > 70 Years Old

Time: Up to Day 28

Measure: Time to Clinical Improvement in Participants with Pre-existing Diseases

Time: Up to Day 28

Measure: Change in Oxygenation Index

Time: Up to Day 28

Measure: Time to Improvement of One Point Using WHO Ordinal Scale Improvement

Time: Up to Day 28

Measure: Percentage of Participants Experiencing WHO Ordinal Scale Improvement of >1 point

Time: Up to Day 28

Measure: Change from Baseline in C-reactive protein (CRP) Levels

Time: Up to Day 28

Measure: Change from Baseline in Ferritin Levels

Time: Up to Day 28

Measure: Change from Baseline in Lactate Dehydrogenase (LDH) Levels

Time: Up to Day 28

Measure: Changes from Baseline in Blood Plasma Cytokines Levels

Time: Up to Day 28

Measure: Number of Participants with Adverse Events (AE)

Time: From start of study drug administration up to Day 28

232 Beaumont Health Large-scale Automated Serologic Testing for COVID-19

The purpose of this study is to determine how peoples' bodies respond to exposure to COVID-19. Employees of Beaumont Health in Michigan who are older than 18 years may be eligible to participate. Participants will have blood drawn two or more times for serology testing. This serology test will determine if participants have detectable levels of the antibodies that our bodies develop to fight COVID-19 infection. Participants will fill out a questionnaire each time they provide a blood sample. The questionnaires include questions about participants' personal traits; their health; general questions about their risk to exposure; job and risk of exposure; symptoms, diagnosis, treatment of COVID-19 since last blood draw. Researchers will monitor participants' medical records in a confidential manner for one year after the last blood draw to help determine if people who develop antibodies to COVID-19 are protected against developing a COVID-19 infection in the future.There may be no direct benefits for participants; however, information from this study may benefit other people by increasing our understanding of COVID-19, how it spreads from person to person, and how people respond to fight off the infection.The results of the serology test are used for research only and will not affect clinical decisions regarding participants' treatment or quarantine

NCT04349202 COVID-19 Coronavirus Infection Severe Acute Respiratory Syndrome Coronavirus 2 Diagnostic Test: EUROIMMUN assay

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Serology testing of Beaumont Health employees will allow an estimation of asymptomatic carriage and help determine level of nosocomial spread of COVID-19 within our institution among its employees. All participants will provide over 2 blood draws between 2 and 4 weeks apart to determine if they developed antibodies to COVID-19. Participants at medium risk for exposure in their job function at Beaumont will have 3 draws 2-4 weeks apart and people considered the highest risk, those who provide the direct patient care to COVID-19 patients, will be tested 2-4 weeks apart until the pandemic in Michigan is under control (estimated to be 8 blood draws).

Measure: Prevalence COVID antibodies in employees of Beaumont Health

Time: 1 year

233 Efficacy and Safety of Favipiravir in Management of COVID-19

Randomized controlled interventional trial (Clinical Trial) phase 3 to assess the safety and efficacy of favipiravir versus the standard care therapy in the treatment of patients with COVID-19.

NCT04349241 Coronavirus Disease (COVID-19) Drug: favipiravir Drug: Standard of care therapy

MeSH:Coronavirus Infections

Primary Outcomes

Description: Two successive negative COVID-19 PCR analysis tests 48-72 hours apart

Measure: Viral clearance

Time: 14 days

Description: Normal body temperature for 48 hours

Measure: Clinical improvement

Time: 14 days

Secondary Outcomes

Description: Improvement of radiological abnormalities at day 14

Measure: Radiological Improvement

Time: 14 days

234 Early Extubation for Patients With Acute Hypoxemic Respiratory Failure

The objective of the study is to evaluate the efficacy of helmet NIV in reducing the duration of invasive mechanical ventilation in order to minimize ventilator needs during the COVID-19 pandemic.

NCT04349332 Mechanical Ventilation Corona Virus Infection Device: Helmet non-invasive ventilation (NIV)

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency

Primary Outcomes

Description: duration of mechanical ventilation via endotracheal tube

Measure: ventilator days

Time: up to 4 weeks

Secondary Outcomes

Description: number of days admitted to the ICU

Measure: Intensive care unit (ICU) length of stay

Time: up to 6 weeks

Description: number of patients requiring endotracheal intubation after extubation

Measure: need for re-intubation

Time: up to 6 weeks

Other Outcomes

Description: number of days spent in hospital during enrollment hospitalization

Measure: hospital length of stay

Time: up to 6 weeks

Description: death from any cause during hospitalization time of enrollment

Measure: hospital mortality

Time: up to 6 weeks

Description: death from any cause 90 day, 1year

Measure: long term mortality

Time: up to 1 year

Description: including ventilator associated pneumonia, GI hemorrhage, DVT/PE, sacral decubitus ulcer, delirium, ICU acquired weakness

Measure: ICU related complications

Time: up to 6 weeks

Description: measure the location (home, rehabilitation center, nursing home)

Measure: discharge location

Time: up to 90 days

Description: days alive and institution free

Measure: health care utilization

Time: up to 6 weeks

Description: ultrasound measurement at end expiration: enrollment, pre extubation, post extubation

Measure: diaphragm ultrasound thickness

Time: up to 6 weeks

Description: ultrasound measurement at end expiration and inspiration to calculate thickening fraction

Measure: diaphragm thickening fraction

Time: up to 6 weeks

235 Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore: a Review of Process Feasibility, Safety, and Clinical Outcomes

Given the high prevalence of COVID19 illness (both SARS-CoV-2 RT-PCR confirmed and highly suspect cases) among healthcare workers (HCW) within the Montefiore Health System (MHS), hydroxychloroquine (HCQ) will be prescribed to healthcare workers who are at the highest risk for severe COVID19 illness.

NCT04350450 COVID Coronavirus COVID-19 Drug: Hydroxychloroquine

MeSH:Coronavirus Infections

Primary Outcomes

Description: Time that it takes for symptoms to be resolved in those who were treated vs untreated

Measure: Time to resolution of symptoms

Time: up to 4 weeks

Secondary Outcomes

Measure: Number of days from onset of illness to symptom resolution

Time: up to 4 weeks

Measure: Number of days to return to work

Time: up to 4 weeks

Measure: Rate of hospital admission in treated and untreated healthcare workers

Time: up to 4 weeks

Measure: Adverse effect of HCQ during treatment

Time: up to 5 days

236 Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 (COVI-PRONE): A Randomized Clinical Trial

The aim of the COVI-PRONE Trial is to determine if early awake prone positioning in COVID-19 patients with hypoxemic respiratory failure; irrespective of the mode of oxygen delivery; reduces the need for invasive mechanical ventilation.

NCT04350723 Corona Virus Infection Procedure: Awake Proning

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Medical procedure in which a tube is placed into the windpipe (trachea) through the mouth.

Measure: Endotracheal intubation

Time: within 30 days of randomization

Secondary Outcomes

Description: Death

Measure: Mortality

Time: 30 days

Description: Number of days not receiving mechanical ventilation

Measure: Invasive mechanical ventilation free days

Time: 30 Days

Description: Number of days not receiving non-invasive mechanical ventilation

Measure: Non-invasive ventilation free days

Time: 30 days

Description: Number of days admitted to ICU

Measure: ICU length of stay

Time: 30 Days

Description: Number of days admitted to the hospital

Measure: Hospital length of stay

Time: 30 days

Description: defined as the difference in SpO2: FiO2 ratio. The difference in SpO2: FiO2 ratio.

Measure: Change in oxygenation

Time: 30 days

Description: Includes any of the following: accidental removal of intravenous access, vomiting, falls from bed, pressure injuries, or cardiac arrest.

Measure: Complications from proning,

Time: 30 days

237 Application of BCG Vaccine for Immune-prophylaxis Among Egyptian Healthcare Workers During the Pandemic of COVID-19

Phase III Placebo-controlled adaptive multi-centre randomized controlled trial Interventional (Clinical Trial). The study will include nine hundred healthcare workers in the isolation hospitals for COVID-19 cases; they will be randomly assigned to receive either BCG vaccine or normal saline.

NCT04350931 Coronavirus Disease (COVID-19) Biological: intradermal injection of BCG Vaccine Other: placebo

MeSH:Coronavirus Infections

Primary Outcomes

Description: Estimate the incidence of confirmed COVID-19 among the healthcare workers in isolation hospitals

Measure: incidence of confirmed COVID-19

Time: 9 months

Description: Evaluate the effectiveness of BCG vaccine in protecting the healthcare workers in isolation hospitals against the risk of COVID-19 infection by detecting any positive cases among vaccinated healthscare workers

Measure: Effectiveness of BCG vaccine

Time: 9 months

238 A Phase 3 Randomized, Placebo-Controlled Study of Lenzilumab in Hospitalized Patients With Severe and Critical COVID-19 Pneumonia

The primary objective of this study is to assess whether the use of lenzilumab in addition to current standard of care can alleviate the immune-mediated cytokine release syndrome (CRS) and reduce the time to recovery in hospitalized subjects with severe or critical COVID-19 pneumonia.

NCT04351152 Coronavirus Disease 2019 (COVID-19) Pneumonia Biological: Lenzilumab Drug: Standard of Care

MeSH:Coronavirus Infections Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: Time to recovery is defined as the first day on which a subject satisfies one of the following 3 categories from the 8-point ordinal scale (Hospitalized, not requiring supplemental oxygen-no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities).

Measure: Time to Recovery

Time: Up to 28 days

Secondary Outcomes

Measure: Incidence of Invasive Mechanical Ventilation and/or Death

Time: Up to 28 days

Measure: Incidence of severe acute respiratory distress syndrome (ARDS)

Time: Up to 28 days

Measure: Duration of Intensive Care Unit (ICU) Stay

Time: Up to 28 days

Measure: Ventilator-free Days

Time: Up to 60 days

Measure: Duration of Hospitalization

Time: Up to 28 days

Measure: Time to Improvement in 1 or 2 Categories using 8-point Ordinal Scale

Time: Up to Day 28

Measure: Time to Death

Time: Up to Day 28

Measure: Number of Subjects Alive and Off Oxygen

Time: Up to 60 days

Description: Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Measure: Percentage of Participants Experiencing Adverse Events

Time: Up to 60 days

Description: Using the NCI CTCAE version 5.0

Measure: Percentage of Participants Experiencing Serious Adverse Events

Time: Up to 60 days

Measure: Proportion of Subjects Discharged from Hospital

Time: Up to Day 60

Measure: All-cause Mortality and Proportion of Subjects Alive

Time: Day 28 and Day 60

Measure: Time to improvement in oxygenation for > 48 hours

Time: Up to Day 28

Measure: Incidence of Non-invasive Ventilation (or Use of High-flow Oxygen Device)

Time: Up to Day 28

Description: NEWS2 consists of: Physiological Parameters: respiration rate (per minute), SpO2 Scale 1 (%), SpO2 Scale 2 (%), use of air or oxygen, systolic blood pressure (mmHg), pulse (per minute), consciousness and temperature (°C)

Measure: Time to Clinical Improvement, Defined as NEWS2 < 2 Maintained for 24 Hours

Time: Up to Day 28

Measure: Change from Baseline to Day 28 in Clinical status Based on the 8-point Ordinal Scale

Time: Up to Day 28

Measure: Duration of Time on Low-flow or High-flow Supplemental Oxygen

Time: Up to Day 28

239 A Systems Approach to Predict the Outcome of SARS-CoV-2 in the Population of a City

This study is to gain critical knowledge to understand the factors influencing the outcome of a pandemic virus within the city of Basel.

NCT04351503 SARS Coronavirus ( SARS Coronavirus (SARS-CoV-2) Infection Other: Study A Other: Study B Other: Study C Other: Study D

MeSH:Coronavirus Infections

Primary Outcomes

Description: Identification of factors associated with (i) infection (binary, yes/no), (ii) hospitalization (binary, yes/no), (iii) requirement for ICU treatment (binary, yes/no)

Measure: Identification of factors associated with (i) infection (binary, yes/no), (ii) hospitalization (binary, yes/no), (iii) requirement for ICU treatment (binary, yes/no)

Time: at baseline

Description: duration of hospitalization (in days)

Measure: duration of hospitalization (in days)

Time: at baseline

Description: duration of ICU stay (in days)

Measure: duration of Intensive Care Unit (ICU) stay (in days)

Time: at baseline

Description: in-hospital mortality (binary, yes/no)

Measure: in-hospital mortality (binary, yes/no)

Time: at baseline

Description: Number of infected cases confirmed either by nucleic acid test (NAT) or by positive serology within the city of Basel expressed as incidence per statistical block

Measure: Number of infected cases within the city of Basel

Time: at baseline

Description: Number, type, and complexity of viral genome variants and quasispecies identified by deep-sequencing during rise, peak, and contraction of the pandemic in patients and geographic areas.

Measure: whole genome sequencing to study pathogen evolution (number, type, and complexity of viral genome)

Time: at baseline

Description: Identification which treatment modality is associated with adverse events (binary, yes/no)

Measure: Identification which treatment modality is associated with adverse events (binary, yes/no)

Time: at baseline

Description: Identification which treatment modality is associated with pulmonary recovery(binary, yes/no)

Measure: Identification which treatment modality is associated with pulmonary recovery (binary, yes/no)

Time: after 30 and 90 days

240 A Multicenter, Randomized, Active Controlled, Open Label, Platform Trial on the Efficacy and Safety of Experimental Therapeutics for Patients With COVID-19 (Caused by Infection With Severe Acute Respiratory Syndrome Coronavirus-2)

The Austrian Coronavirus Adaptive Clinical Trial (ACOVACT) is a randomized, controlled, multicenter, open-label basket trial that aims to compare various antiviral treatments for COVID-19. Moreover three substudies have been integrated. Currently, patients will be randomized to receive (hydroxy-)chloroquine, lopinavir/ritonavir or standard of care. Moreover, these patients are eligible for substudy A (randomized to rivaroxaban 5mg 1-0-1 vs. standard of care), substudy B (renin-angiotensin (RAS) blockade vs. no RAS blockade for patients with blood pressure >120/80mmHg), and substudy C (clazakizumab vs standard of care, for patients with respiratory deterioration and high inflammatory biomarkers). Endpoints were chosen based on the master protocol published by the World Health Organisation and include a 7-point scale of clinical performance, mortality, oxygen requirement (both dose and type), duration of hospitalization, viral load and safety.

NCT04351724 COVID-19 Drug: Chloroquine or Hydroxychloroquine Drug: Lopinavir/Ritonavir Other: Best standard of care Drug: Rivaroxaban Drug: Thromboprophylaxis Drug: Candesartan Drug: non-RAS blocking antihypertensives Drug: Clazakizumab Drug: placebo for clazakizumab

MeSH:Coronavirus Infections

Primary Outcomes

Description: The primary endpoint is time to clinical improvement which is defined as time from randomization to an (sustained) improvement of at least one category on two consecutive days compared to the status at randomization measured on a seven-category ordinal scale (proposed by WHO). The 7-categories of the World Health Organization proposed scale, as follows: Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death. During hospitalization this score will be determined daily (till day 29). If a patient is released from the hospital before day 29, the score will be determined at day 11 and 29 after randomization (depending when the patient was released or by telephone call).

Measure: sustained improvement (>48h) of one point on the WHO Scale

Time: Inclusion to day 29, daily evaluation

Secondary Outcomes

Description: The scale described in the primary endpoint is used

Measure: Time to improvement on WHO Scale

Time: Inclusion to day 29, daily evaluation

Description: The scale described in the primary endpoint is used

Measure: Mean change in the ranking on an ordinal scale from baseline

Time: Inclusion to day 29, daily evaluation

Description: the National Early Warning Score includes respiratory rate, oxygen saturation, use of supplemental oxygen, temperature, systolic blood pressure, heart rate and levels of consciousness (AVPU Scale)

Measure: time to discharge or a National Early Warning Score (NEWS) ≤2 (maintained for 24h), whichever occurs first

Time: Inclusion to day 29, daily evaluation

Description: The scale described in the primary endpoint is used

Measure: change from baseline in National Early Warning Score (NEWS)

Time: Inclusion to day 29, daily evaluation

Measure: Oxygenation free days

Time: Inclusion to day 29, daily evaluation

Description: new oxygen may include insufflation or oxygen mask, high flow oxygen devices, non-invasive ventilation devices or mechanical ventilation

Measure: Incidence of new oxygen use during the trial

Time: Inclusion to day 29, daily evaluation

Measure: duration of oxygen use during the trial

Time: Inclusion to day 29, daily evaluation

Description: number of days with requirement of mechanical ventilation

Measure: Ventilator free days until day 29

Time: Inclusion to day 29, daily evaluation

Measure: Incidence of new mechanical ventilation use during the trial

Time: Inclusion to day 29, daily evaluation

Measure: duration of mechanical ventilation use during the trial

Time: Inclusion to day 29, daily evaluation

Description: obtained by polymerase chain reaction in nasal/oropharyngeal swabs, performed at baseline and then three times a week, if possible

Measure: Viral load/viral clearance

Time: Inclusion to day 29, daily evaluation

Measure: Duration of Hospitalization

Time: Inclusion to day 29, daily evaluation

Measure: Mortality

Time: 15-day, 29-day mortality

Description: BMI (kg/m2), within all subjects the impact of obesity on overall mortality will be investigated

Measure: Obesity - mortality

Time: BMI at admission, mortality until day 29

Description: BMI (kg/m2) , within all subjects the impact of obesity on the duration of hospitalization will be investigated

Measure: Obesity - duration of hospitalization

Time: BMI at admission, duration of hospitalization until day 29 or discharge

Description: BMI (kg/m2) , within all subjects the impact of obesity on ICU admission will be investigated

Measure: Obesity - ICU admission

Time: BMI at admission, ICU admission until day 29 or discharge

Description: BMI (kg/m2) new oxygen may include insufflation or oxygen mask, high flow oxygen devices, non-invasive ventilation devices or mechanical ventilation

Measure: Obesity - new oxygen use

Time: BMI at admission, new oxygen use until day 29 or discharge

Description: lopinavir and ritonavir both interact with numerous other drugs by inhibiting the cytochrome enzymes 3A4. Using commercially available drug-interaction programs, the number and severity grading of drug-drug-interactions will be documented (for instance uptodate interaction tool, medscape). This is an exploratory analysis of drug-drug interactions with the above mentioned substances. severity grading usually encompass "contraindicated", "serious", "monitor closely", "minor" interaction.

Measure: Drug-drug interactions with lopinavir/ritonavir

Time: Inclusion to day 29, daily evaluation

Description: for sub-study B only: RAS fingerprint measures metabolites involved in the renin-angiotensin-system. The influence of randomized treatment with candesartan (RAS blockade) will be analyzed

Measure: Renin Angiotensin System (RAS) fingerprint

Time: Inclusion to day 29, daily evaluation

241 CORonavirus (COVID-19) Diagnostic Lung UltraSound Study

This observational study is designed to assess whether focused lung ultrasound examination can improve the diagnosis of COVID-19 lung disease and/or make an alternative diagnosis at a patient's initial hospital presentation. For patients with confirmed COVID-19 the study will also assess whether surveillance lung ultrasound examination can predict clinical outcome over the course of their hospital admission.

NCT04351802 COVID-19 Diagnostic Test: Lung ultrasound

MeSH:Coronavirus Infections

Primary Outcomes

Description: Primary and blinded scorer diagnosis of COVID-19 on lung ultrasound

Measure: Diagnosis of COVID-19 on lung ultrasound

Time: On day of admission to hospital

Description: Primary and blinded scorer diagnosis of COVID-19 on lung ultrasound vs. radiologist-reported chest x-ray findings

Measure: Difference in diagnosis of COVID-19 on lung ultrasound vs. chest x-ray

Time: On day of admission to hospital

Secondary Outcomes

Description: Primary and blinded scorer diagnosis of alternative condition on lung ultrasound

Measure: Diagnosis of alternative condition to COVID-19 on lung ultrasound vs. chest x-ray

Time: On day of admission to hospital

Description: Comparison of lung ultrasound findings with clinical markers of COVID-19 disease severity e.g. supplementary oxygen requirements

Measure: Ability of surveillance lung ultrasound to predict clinical trajectory / outcome in patients with COVID-19

Time: During hospital admission

Description: Comparison of primary and blinded scorer evaluation of lung ultrasound scans for consistency of interpretation and diagnosis

Measure: Consistency of lung ultrasound interpretation in patients presenting with suspected COVID-19

Time: On day of admission to hospital

242 Registry for Clinical Presentation and Management of Patients With COVID-19 in the Emergency Room

Patients with COVID-19 usually present in the ED and receive their initial medical check-up here. We will try to gather information of comorbidities and other conditions at the time of presentation of COVID-19 patients to the ED. The course of the disease prior to admission as well as the momentary health status at presentation to the ED are of interest because they influence risk stratification and decision-making of treating physicians. The ratio of patients with mild or moderate to severe symptoms will help to calculate the need for hospital beds including beds on Intensive Care Units (ICU) and Intermediate Care Units (IMC), as well as the need for other hospital resources.

NCT04351854 Corona Virus Infection SARS-CoV 2 Other: Retrospective data collection

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Emergencies

Primary Outcomes

Description: Identification of risk factors present at the earliest stage of hospital care (i.e. in the ED) that warrant hospital admission.

Measure: Identification of risk factors present at the earliest stage of hospital care (i.e. in the ED) that warrant hospital admission.

Time: 6 months

Secondary Outcomes

Description: Determination of the course of the disease (days since onset of symptoms, nature of symptoms, e.g. fever, chills, headache) and the state at which patients present to the ED

Measure: Determination of the course of the disease (days since onset of symptoms, nature of symptoms, e.g. fever, chills, headache) and the state at which patients present to the ED

Time: 6 months

Description: Identification of the ratio of patients with mild or moderate to severe disease

Measure: Identification of the ratio of patients with mild or moderate to severe disease

Time: 6 months

243 Evaluating the Use of Polymyxin B Cartridge Hemoperfusion for Patients With Septic Shock and COVID 19

Prospective, observational, clinical investigation of PMX cartridge use in COVID 19 patients with septic shock

NCT04352985 Septic Shock Endotoxemia COVID Corona Virus Infection Sepsis, Severe Device: Toraymyxin PMX-20R (PMX Cartridge)

MeSH:Shock, Septic Endotoxemia Sepsis Coronavirus Infections Severe Acute Respiratory Syndrome Shock

HPO:Sepsis

244 PATCH 2 & 3: (Prevention and Treatment of COVID-19 With Hydroxychloroquine) An Open Label Multi-arm Randomized Trial of Hydroxychloroquine in the Prevention and Treatment of COVID-19

The proposed hypothesis is that high doses of hydroxychloroquine (HCQ) for at least 2 weeks can be effective antiviral medication both as a treatment in ambulatory patients and prophylaxis/treatment in health care workers because it impairs lysosomal function and reorganizes lipid raft (cholesterol and sphingolipid rich microdomains in the plasma membrane) content in cells, which are both critical determinants of Emerging Viral Disease (EVD) infection. This hypothesis is based on a growing literature linking chloroquine to antiviral activity. It is estimated that enough information exists to launch a clinical trial of hydroxychloroquine for COVID-19.

NCT04353037 Coronavirus Corona Virus Infection Drug: Group A HCQ Drug: Group B Control

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Rate of hospitalization

Measure: Sub Study 1: Patients

Time: 21 days

Description: Rate of COVID-19 infection (confirmed by accepted testing methods) at 2 months

Measure: Sub Study 2: Health Care Workers

Time: 2 months

Secondary Outcomes

Description: any house hold member who has reported symptoms or test positive for COVID 19 during their 14 day active participation

Measure: Sub Study 1: Patients: Rate of secondary infection of co-inhabitants

Time: 14 days after enrollment of the household

Description: Assessment of any medical events that occur during the 14 day active period that is felt to be related to receipt of HCQ

Measure: Sub Study 1: Patients: Adverse Events

Time: 14 day active period

Description: If a test comes back negative, participant would be notified as such and told to destroy their pills as they are withdrawn

Measure: Sub Study 1: Patients: Negative for COVID-19

Time: up to 5 days after enrolling

Description: Any work time missed because the participant experienced COVID-like symptoms during their active 2 month period

Measure: Sub Study 2:Health Care Workers:Number of shifts missed

Time: up to ~60 days after enrollment

Description: Assessment of any medical events that occur during the ~60 day active period that is felt to be related to receipt of HCQ

Measure: Sub Study 2:Health Care Workers:Rate of adverse events

Time: up to ~60 days after enrollment

Description: if the participant gets COVID and has severe symptoms and hospitalized, end point reached if before the end of the 2 month period

Measure: Sub Study 2:Health Care Workers:Rate of hospitalization

Time: up to ~60 days after enrollment

245 Multicenter Randomized Controlled Trial of the Efficacy of Melatonin in the Prophylaxis of SARS-coronavirus-2 Infection Among High Risk Contacts.

There is an urgent need to evaluate interventions that can prevent the infection with SARS-CoV 2 of healthcare workers at risk. Melatonin is an inexpensive and safe product with protective effect in both bacterial and viral infections likely due to its anti-inflammatory and anti-oxidative effects. This randomized controlled trial seeks to evaluate is efficacy as a prophylaxis in healthcare workers exposed to the virus in their clinical practice.

NCT04353128 Covid19 SARS-CoV 2 Coronavirus Infection Drug: Melatonin 2mg Drug: Placebo oral tablet

MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of confirmed (positive CRP) symptomatic infections in each treatment group

Measure: SARS-CoV 2 infection rate

Time: up to 12 weeks

246 Study of Biomarkers in the Long-term Impact of Coronavirus Infection in the Cardiorespiratory System: Effect of Hydroxychloroquine / Azithromycin Combined Therapy

Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) poses a significant threat to global health. As the disease progresses, a series of acute complications tend to develop in multiple organs. Beyond the supportive care, no specific treatment has been established for COVID-19. The effectiveness, both short-term and long-term, of some promising antivirals, such as the hydroxychloroquine combination with azithromycin, needs to be evaluated. This study aims to investigate the predictive role of cardiac biomarkers and pulmonary symptoms for late complications of COVID-19 coronavirus infection on the heart and lung in patients treated with the hydroxychloroquine / azithromycin combination therapy. Thus, COVID-19 coronavirus patients undergoing hydroxychloroquine / azithromycin combination therapy will be compared to patients not undergoing this therapy. The comparison will be made by the analysis of the relationships between (1) levels of ultrasensitive cardiac troponins collected at the beginning of the infection and cardiac magnetic resonance data in the 3rd and 12th months of troponin collection and (2) findings CT scans and the results of the ergospirometers tests performed in those same periods. It is expected to demonstrate that: (1) cardiac troponin and lung tomographic findings can predict late complications of COVID-19 coronavirus infection in the heart and lung, assessed by cardiac magnetic resonance and ergospirometers one year after the beginning of the infection, and (2) hydroxychloroquine / azithromycin combined therapy can abolish the onset of these complications late. Furthermore, the results may point to the need for more rigorous monitoring of cardiologists and pulmonologists of these patients, due to the risk of hemodynamic complications, arrhythmogenic and respiratory.

NCT04353245 COVID19 Corona Virus Infection Myocardial Injury Pneumonia Other: BIOMARKERS IN THE LONG TERM IMPACT OF CORONAVIRUS INFECTION IN THE CARDIORRESPIRATORY SYSTEM

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Virus Diseases

HPO:Pneumonia

Primary Outcomes

Description: presence of fibrosis on cardiac resonance and / or decreased functional capacity on ergospirometry

Measure: Fibrosis

Time: 12 months

Description: Decreased functional capacity on ergospirometers

Measure: Ergospirometers

Time: 12 monthes

247 A Randomized Phase 2/3 Trial of Hydroxychloroquine In Covid-19 Kinetics

To test if the medication Hydroxychloroquine will decrease the amount of virus(as measured by PCR) , 7 days after initiation of therapy compared to control patients receiving placebo. The study design is a randomized (5 days of medication v. 5 days of placebo) clinical trial initiated immediately after diagnosis in ambulatory health care workers at University of South Alabama Health, or in ambulatory USA patients. At 7 days after enrollment another nasopharyngeal swab will be taken to measure if the virus is still present. At 10 weeks we will measure immunity from Covid-19 using a single blood sample. It is a phase 2/3 clinical trial.

NCT04353271 Covid 19 Corona Virus Infection Drug: Hydroxychloroquine Other: Placebo

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Nasopharyngeal swab PCR measurement of viral load expressed as the % of negative PCR swabs

Measure: Percentage of virus free subjects

Time: 7 days after initiation of trial

Description: Participants will self-report disease severity status as one of the following 5 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization (score of 3), or Covid 19 with care requiring hospitalization (score of 4), or Covid 19 with death (Score of 5) .

Measure: Disease severity

Time: 6 days

Secondary Outcomes

Description: Number of subjects in each arm who are hospitalized for Covid 19 infection

Measure: Incidence of hospitalization

Time: 14 days

Description: Number of subjects in each arm who die secondary to Covid-19 infection

Measure: Incidence of Death

Time: 70 Days (10 weeks)

Description: Number of subjects in each arm who have confirmed Covid-19 infection

Measure: Incidence of confirmed SARS-CoV-2 Detection

Time: 14 days

Description: Number of subjects in each arm who discontinue or withdraw medication use for any reason

Measure: Incidence of all-cause study medication discontinuation or withdrawal

Time: 14 days

Description: Blood tests to determine level of immunity in each subject

Measure: Immunity to Covid-19

Time: 70 days (10 weeks)

248 Clinical Study Evaluating the Efficacy of Chloroquine or Hydroxychloroquine in COVID-19 Treatment

Chloroquine or hydroxychloroquine in COVID-19 treatment

NCT04353336 COVID-19 Coronavirus Infection Drug: Chloroquine or Hydroxychloroquine

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: the number of patients with cure or death

Measure: Number of patients with cure or death

Time: 1 month

249 WHOLE GENOME SEQUENCING ANALYSIS OF SARS-COV-2 POSITIVE PATIENTS

We aim to better understand the mode of action of SARS-CoV-2 in the context of its interaction with the host genome through whole genome sequencing.

NCT04353401 Coronavirus Infection SARS-CoV-2

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Clinical associations with human and viral genetics

Measure: Associations with severity and outcomes

Time: next 6 months

250 Renal Outcome in Patients With Coronavirus Disease 2019 (COVID-19)

Acute kidney injury (AKI) is reported to occur in 0.5-9% of severe acute respiratory distress coronavirus 2-positive patients and AKI has been identified as an independent risk factor for in-hospital mortality. The present study aims to investigate the incidence of renal outcome of in-hospital patients diagnosed with COVID-19.

NCT04353583 Acute Kidney Injury Corona Virus Infection

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Acute Kidney Injury

HPO:Acute kidney injury

Primary Outcomes

Description: As determined by Kidney Disease: Improving Global Outcomes (KDIGO) criteria

Measure: Incidence of AKI

Time: Within 7 days after admission

Secondary Outcomes

Description: Serial biomarker assessment

Measure: Renal function changes during hospital stay

Time: from hospital admission til discharge up to 3 months

Description: As determined by KDIGO criteria

Measure: Incidence of chronic kidney disease

Time: 3 months post-hospital admission

251 The Ariel University Survey on Dietary Changes and Anxiety During the Coronavirus Pandemic: TARUS

Background/Objectives: Psychological anxiety has been associated with alterations in eating patterns. The 2020 global coronavirus pandemic has created a situation characterized by increased anxiety. The present international survey was designed to examine associations between exposure to quarantine/isolation measures, anxiety levels and changes in dietary patterns. Methods: The present study utilizes a Google Survey platform to conduct an international survey querrying dietary patterns before vs. after the coronavirus pandemic; anxiety during the pandemic; and demographic characteristics. The nutrition portion of the survey is based on the Mediterranean Diet Score while the anxiety estimate is based on the GAD-7. The survey is available in English, Hebrew, Spanish, Italian, French, Arabic and Russian. It has been distributed via social media. Anticipated Results: We believe that changes in dietary habits will be identified and that these will be associated with anxiety levels. Additionally, we believe that by-country differences will be identified. Discussion: The Google Survey format distributed by social media provides an almost immediate means of distributing the survey globally. The survey can only be completed if the respondent first indicates his/her informed consent. The convenience sample limits generalizability to individuals who volunteer to complete online surveys; however, we anticipate a large response which may mitigate this limitation.

NCT04353934 Dietary Habits Anxiety

MeSH:Coronavirus Infections Anxiety Disorders

Primary Outcomes

Description: The Mediterranean Diet Score (MedDiet Score) will be calculated and correlated to the Anxiety Score (GAD-7)

Measure: The association between Mediterranean Diet Score and Anxiety Score

Time: through study completion, average six months

Description: Mediterranean Diet Score (MedDiet) will be calculated

Measure: The degree to which current dietary intake is consisten with the Mediterranean Diet

Time: through study completion, average six months

Secondary Outcomes

Description: By-country comparisons of the association between Mediterranean Diet (MedDiet) score and Anxiety (GAD-7)

Measure: By-country comparisons of the association between Mediterranean Diet (MedDiet) score and Anxiety

Time: through study completion, average six months

252 Antikörperseroprävalenz Und Hintergrundinfektionsrate Von SARS-CoV-2 in Einem österreichischen Schlüsselkollektiv an Arbeitnehmer*Innen

Context: On March 11, the World Health Organization (WHO) announced the current corona virus disease 2019 (COVID-19) outbreak as a pandemic. The first laboratory-confirmed case of COVID-19 in Austria was announced on February 27, 2020. Since then, the incidence of infection follows a gradual increase. Measurements taken by the Austrian government include travel restrictions, closing of national borders, social distancing, a mandatory use of facemasks in public, and closing of stores and restaurants. The underlying aim of those imposed restrictions is to contain the viral transmission and to slow spreading of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Objectives: The aims of this study are to determine i) how many employees in Austrian trauma hospitals and rehabilitation facilities have virus specific IgG and IgM antibodies against SARS-CoV-2, ii) how many are active virus carriers (symptomatic and asymptomatic), iii) how many employees are in their incubation period during the study period, and iv) to calculate the SARS-CoV-2 prevalence together with a specific occupation associated infection risk within the different specifications of health care workers. Study Design: Open uncontrolled observational cross-sectional study. Setting/Participants: A total of 4000 employees in 11 Austrian trauma hospitals and rehabilitation facilities of the Austrian Social Insurance for Occupational Risks (AUVA) will be invited to participate in the study. Study Interventions and Measures: An antibody test for SARS-CoV-2 specific IgG and IgM antibodies, and a RT-PCR test based on oropharyngeal swab samples, as well as laboratory-based antibody tests using ELISA, will be implemented to ensure protection and preservation of health in hospital staff and are not part of the study. The tests will be conducted twice, with approximately two weeks in between testing. The results of the tests will be used for statistical analysis in this study together with a questionnaire including questions related to personal health, traveling activities, living situation, as well as inquiries of symptoms and comorbidities.

NCT04354779 Severe Acute Respiratory Syndrome Coronavirus 2 SARS-CoV 2 Coronavirus Infection Covid19 Diagnostic Test: a specifically designed self-administered questionnaire

MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: To determine how many employees in Austrian trauma hospitals and rehabilitation facilities have already virus specific IgG and IgM antibodies against SARS-CoV-2.

Measure: Antibody status in HCW

Time: 4 months

Description: To determine how many are actively infected with or without showing symptoms.

Measure: Active virus carriers in HCW

Time: 4 months

Description: To determine how many employees are in their incubation period during study time.

Measure: Incubation time

Time: 4 months

Secondary Outcomes

Description: To evaluate the "background incidence rate" of COVID-19 to calculate the SARS-CoV-2 prevalence in a defined cohort of the Austrian population.

Measure: Background incidence rate

Time: 4 months

Description: To calculate a specific occupation associated infection risk within the different specifications of health care workers amongst AUVA employees.

Measure: Occupation associated infection risk

Time: 4 months

253 Efficacy of Captopril Nebulization in Covid-19 Patients Suffering of SARS CoV-2 Pneumonia. A Randomized Phase II Study

Captopril being an effective drug available in liquid preparation, administration by nebulization could be of interest for maximizing lung action and minimizing systemic side effects. Such a treatment might be used for "Covid-19" patients with pneumonia in order to avoid ARDS.

NCT04355429 Pneumonia Coronavirus Infection COVID-19 Drug: captopril 25mg

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: To assess determine the efficacy of captopril nebulization addition to standard of care compared to standard of care in term of 14-day ventilation free survival

Measure: Efficacy of captopril nebulization addition to standard of care compared to standard of care.

Time: 14 Days

254 Treatment With Inhaled Corticosteroids in Patients Hospitalized Because of COVID19 Pneumonia

Randomized, prospective, controlled open label clinical trial aimed at investigating if the addition of inhaled corticosteroids (budesonide) reduces treatment failure (defined as a composite variable by the initiation of treatment with high flow-O2 therapy, non-invasive or invasive ventilation, systemic steroids, use of biologics (anti IL-6 or anti IL-1) and/or death) according to hospital standard of care guidance) at day 15 after initiation of therapeutic intervention.

NCT04355637 Coronavirus Infection Drug: Inhaled budesonide

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: composite variable that includes the initiation of treatment with high flow-O2 therapy, non-invasive or invasive ventilation, systemic steroids, use of biologics (anti IL-6 or anti IL-1) and/or death) at day 15 after initiation of therapeutic intervention

Measure: Proportion of patients in both arms fulfilling the criteria for treatment failure

Time: 15 days after treatment

Secondary Outcomes

Description: Yes/no

Measure: ICU admission

Time: baseline, day 3, day 7, day 15, day 30

Description: yes/no and reason

Measure: ICU refusal

Time: baseline, day3, day 7, day 15, day 30

Description: infectious cardiovascular and /or metabolic complications as well as variation in the 7 point WHO scale.

Measure: Occurrence of complications

Time: baseline, day3, day 7, day 15, day 30

Description: U/L

Measure: lactate dehydrogenase (LDH)

Time: at baseline, day 3, day 7, day 15, day 30

Description: mg/dL

Measure: C Reactive Protein (CRP)

Time: at baseline, day 3, day 7, day 15, day 30

Description: ng/mL

Measure: ferritin

Time: at baseline, day 3, day 7, day 15, day 30

Description: ng/mL

Measure: D-dimer

Time: at baseline, day 3, day 7, day 15, day 30

Description: x10^9/L

Measure: leukocyte counts

Time: at baseline, day 3, day 7, day 15, day 30

255 A Phase 2 Randomized, Open-Label, Multicenter Study to Evaluate the Activity and Safety of Two Regimens of Low Dose Oral Selinexor in Patients With Moderate or Severe COVID-19

The main purpose of this study is to evaluate the activity, safety and reduction in mortality of two regimens of low dose selinexor (KPT-330) in patients with moderate or severe COVID-19.

NCT04355676 Coronavirus Infection Drug: Selinexor

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Percentage of Participants with at Least a 2 Point Improvement in the Ordinal Scale

Time: Baseline to Day 14

Secondary Outcomes

Measure: Time to Clinical Improvement (TTCI)

Time: Up to Day 28

Measure: Overall Death Rate

Time: Day 14, Day 28

Measure: Rate of Mechanical Ventilation

Time: Up to Day 28

Measure: Time to Mechanical Ventilation

Time: Up to Day 28

Measure: Overall Survival

Time: Up to Day 28

Measure: Time to Improvement (2 points) in Clinical Measures Using the Ordinal Scale

Time: Up to Day 28

Measure: Time to Intensive Care Unit (ICU) Admission

Time: Up to Day 28

Measure: Rate of Intensive Care Unit (ICU) Admission

Time: Up to Day 28

Measure: Length of Stay in Hospital

Time: Up to Day 28

Measure: Percentage of Participants Discharged From Hospital

Time: Up to Day 28

Measure: Length of Stay in Intensive Care Unit (ICU)

Time: Up to Day 28

Measure: Duration of Oxygen Supplementation

Time: Up to Day 28

Measure: Duration of Mechanical Ventilation

Time: Up to Day 28

Measure: Time to Clinical Improvement in Participants ≤ 70 Years Old

Time: Up to Day 28

Measure: Time to Clinical Improvement in Participants > 70 Years Old

Time: Up to Day 28

Measure: Time to Clinical Improvement in Participants with Pre-existing Diseases

Time: Up to Day 28

Measure: Change in Oxygenation Index

Time: Up to Day 28

Measure: Time to Improvement of One Point Using WHO Ordinal Scale Improvement

Time: Up to Day 28

Measure: Percentage of Participants Experiencing WHO Ordinal Scale Improvement of >1 point

Time: Up to Day 28

Measure: Change from Baseline in C-reactive protein (CRP) Levels

Time: Up to Day 28

Measure: Change from Baseline in Ferritin Levels

Time: Up to Day 28

Measure: Change from Baseline in Lactate Dehydrogenase (LDH) Levels

Time: Up to Day 28

Measure: Number of Participants with Adverse Events (AE)

Time: From start of study drug administration up to follow-up (Day 30)

256 Umbilical Cord-derived Mesenchymal Stem Cells for COVID-19 Patients With Acute Respiratory Distress Syndrome (ARDS)

The purpose of this research study is to learn about the safety and efficacy of human umbilical cord derived Mesenchymal Stem Cells (UC-MSC) for treatment of COVID-19 Patients with Severe Complications of Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS).

NCT04355728 Corona Virus Infection ARDS ARDS, Human Acute Respiratory Distress Syndrome COVID-19 Biological: Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care. Other: Vehicle + Heparin along with best supportive care

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Description: Safety will be defined by the incidence of pre-specified infusion associated adverse events as assessed by treating physician

Measure: Incidence of pre-specified infusion associated adverse events

Time: Day 5

Description: Safety will be defined by the incidence of severe adverse events as assessed by treating physician

Measure: Incidence of Severe Adverse Events

Time: 90 days

Secondary Outcomes

Description: Number of participants that are alive at 90 days post first infusion follow up.

Measure: Survival rate after 90 days post first infusion

Time: 90 days

Description: Number of days participants were off ventilators within up to 28 days of hospitalization

Measure: Ventilator-Free Days

Time: 28 days or hospital discharge, whichever is earlier

Description: Measure the fraction of inspired oxygen (FiO2) and its usage within the body during intensive care, measured using fNIRS (Functional Near Infrared Spectroscopy).

Measure: Change in Oxygenation Index (OI)

Time: 28 days

Description: Measuring respiratory mechanics in ventilated patients [plateau pressure (Pplat)-positive end-expiratory pressure]

Measure: Plat-PEEP

Time: 28 days

Measure: Sequential Organ Failure Assessment (SOFA) Scores

Time: 28 days

Description: The SIT is a self-administered 40-item test involving microencapsulated (scratch-and-sniff) odors with a forced-choice design. The test has a total score ranging from 0-40 Follows scoring key for evaluation. The higher score indicates better outcome.

Measure: Small Identification Test (SIT) scores

Time: At baseline, day 18 and day 28.

Description: As assessed via serum blood samples.

Measure: Troponin I levels

Time: Baseline, 28 days

Description: As assessed via serum blood samples.

Measure: C-Reactive Protein levels

Time: Baseline, 28 days

Description: As assessed via serum blood samples.

Measure: Arachidonic Acid (AA)/Eicosapentaenoic Acid (EPA) Ratio

Time: Baseline, 28 days

Description: As assessed via serum blood samples.

Measure: D-dimer levels

Time: Baseline, 28 days

Description: As assessed via serum blood samples.

Measure: 25-Hydroxy Vitamin D levels

Time: Baseline, 28 days

Description: As assessed via serum blood samples.

Measure: Alloantibodies levels

Time: Baseline, 28 days

Description: As assessed via serum blood samples.

Measure: Blood white cell count

Time: Baseline, 28 days

Description: As assessed via serum blood samples.

Measure: Platelets count

Time: Baseline, 28 days

257 Long Term Physical Functional Performance in Daily Living in SARS-CoV2 Infected Patients Hospitalized in the Acute Phase Then Requiring Rehabilitation: a Multicentric Observational Study

Infection with coronavirus SARS-CoV2 (COVID-19 disease) is unique with its speed of propagation, structural medical reorganizations and length of stay in intensive care needed, diversity of the affected population (in particular between young persons or fragile subjects), and impact on physical and mental health generated by confinement of populations. Fatigue is a major component of COVID-19. Global muscular weakness is related to immobility, inflammation, corticosteroids treatment, hypoxemia due to pulmonary and/or cardiac infectious attacks and undernutrition suggests major physical functional repercussions. Thus, patients affected by COVID-19 with acute hospital management require sometimes complex rehabilitation management. Retrospective studies on physical functional capacities in patients infected with SARS CoV1 showed long term physical activity limitations.

NCT04356378 Infection With Coronavirus SARS-CoV2 Other: Data record

MeSH:Coronavirus Infections

Primary Outcomes

Description: Physical functional limitations evaluated using 'sit to stand' test. The patient, seated in a chair without armrest, his arms crossed over his shoulders, should get up and sit down without help of the upper limbs as many times as possible in one minute.

Measure: Physical functional limitations

Time: 12 months

258 Outpatient Treatment of Elderly People With Symptomatic SARS-CoV-2 Infection (COVID-19): a Multi-arm, Multi-stage (MAMS) Randomized Trial to Assess the Efficacy and Safety of Several Experimental Treatments to Decrease the Risk of Hospitalization or Death (COVERAGE Trial)

This trial will estimate the efficacy and tolerance of several experimental treatments to prevent hospitalization or death in outpatients aged 60 years or above with Symptomatic SARS-CoV-2 Infection (COVID-19).

NCT04356495 Corona Virus Infection Sars-CoV2 Dietary Supplement: Vitamins Drug: Imatinib Drug: Telmisartan

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Proportion of participants with an occurrence of hospitalization

Time: From inclusion (day0) to day 14

Description: Proportion of participants with an occurrence of death

Measure: Death

Time: From inclusion (day0) to day 14

Secondary Outcomes

Measure: Proportion of hospitalizations, overall and by cause, in each group

Time: From inclusion (day0) to day 28

Description: Proportion of deaths, overall and by cause, in each group

Measure: Death and causes of death

Time: From inclusion (day0) to day 28

Measure: Proportion of intensive care hospitalizations, overall and by cause, in each group

Time: From inclusion (day0) to day 28

Measure: Proportion of participants with negative nasopharyngeal SARS-CoV-2 RT-PCR

Time: day 7 and day 14

Measure: Proportion of participants with a loss of autonomy evaluated by the ADL and IADL scale

Time: day 14 and day 28

Description: Evolution of Haematological markers in each group : Complete Blood Count, prothrombin level, INR

Measure: Haematological markers evolution

Time: from inclusion (day 0) to day 7 and day 14

Description: Evolution of Biochemical markers in each group : ferritin, serum creatinine, urea, sodium, potassium, chlorine, calcium, magnesium, albumin, bicarbonates / tCO2, LDH, CPK, ASAT, ALAT, uricemia

Measure: Biochemical markers evolution

Time: from inclusion (day 0) to day 7 and day 14

Description: Evolution of Inflammatory markers in each group : PCT, CRP

Measure: Inflammatory markers evolution

Time: from inclusion (day 0) to day 7 and day 14

Description: Evolution of immunological markers in each group : B ans T Cells phenotypic profiles

Measure: Immunological markers evolution

Time: from inclusion (day 0) to day 7 and day 14

Description: Number and proportion of grade 1,2,3,4 adverse events in each group

Measure: Adverse events

Time: from inclusion (day 0) to day 14

Description: Number and proportion of grade 1,2,3,4 adverse events in each group

Measure: Adverse reactions

Time: from inclusion (day 0) to day 14

Description: Plasma concentration of the study drugs at D7

Measure: Plasma concentration

Time: day 7

Description: Acceptability of the treatment by participant will be assessed with an interview

Measure: Acceptability of the treatment

Time: from inclusion (day 0) to day 10

259 COPLA Study: Treatment of Severe Forms of COronavirus Infection With Convalescent PLAsma

COVID-19 disease has become a very serious global health problem. Treatments for severe forms are urgently needed to lower mortality. Any procedure that improves these forms should be considered, especially those devoid of serious side effects.There is not enough published information on the use of allogeneic convalescent plasma (ACP) in the treatment of severe forms of COVID-19. The use of ACP can be combined with other treatments and has very few adverse effects. It takes 10-14 days for SARS-CoV2-infected patients to produce virus-neutralizing antibodies: within that time they can develop serious complications and die. Injecting PAC into patients with severe forms of COVID-19 shortens the period of risk while the patient produces the antibodies.

NCT04357106 COVID-19 Biological: Convalescent plasma

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: PaO2/FiO2 relation

Measure: Lung injury

Time: 7 days

Description: Patients survival after therapy

Measure: Overall survival

Time: 15-30 days

Secondary Outcomes

Description: Determine the incidence of side effects from plasma administration

Measure: Adverse reactions to plasma

Time: 7 days

260 Rapid Salivary Test to Detect SARS-CoV-2 (COVID-19): a Diagnostic Accuracy Study

The present Diagnostic Accuracy study aims at experimentally validating the use of a rapid salivary test to detect SARS-CoV-2 infection in both symptomatic and asymptomatic individuals as a preliminary approach to a mass screening program. The study is based on a consecutive recruitment of both patients showing symptoms probably associated with COVID-19 (i.e., cough, dyspnea, fever) and asymptomatic patients with a low risk phenotype. The expected number of recruited individuals is 100. The experimental test is a prototype of salivary test based on the Lateral Flow Immunoassay technique and is able to detect the presence of SARS-CoV-2 in saliva, especially the Spike protein (S). The comparison is represented by the nasopharyngeal swab, the gold standard of COVID-19 diagnosis. Patients will undergo both salivary immunoassay and nasopharyngeal swab, thus the outcome assessors are blinded, since the results of the rRT-PCR analysis require at least 6 hours before being available. The main outcomes are sensibility and specificity of the rapid salivary test, when compared with the gold standard (nasopharyngeal swab).

NCT04357327 COVID-19 SARS-CoV 2 Corona Virus Infection Diagnostic Test: rapid salivary test

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: TP/TP+FN (TP= True Positive; FN = False Negative)

Measure: Sensibility

Time: Salivary test will be interpreted after 10 minutes; the nasopharyngeal swab after 6 hours; sensitivity recorded through study completion, an average of 2 months.

Description: TN/TN+FP (TN= True Negative; FP= False Positive)

Measure: Specificity

Time: Salivary test will be interpreted after 10 minutes; the nasopharyngeal swab after 6 hours; specificity recorded through study completion, an average of 2 months.

261 suPAR-guided Anakinra Treatment for Validation of the Risk and Early Management of Severe Respiratory Failure by COVID-19: The SAVE Open-label, Non-randomized Single-arm Trial

In the SAVE study patients with lower respiratory tract infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at high risk for progression to serious respiratory failure will be detected using the suPAR biomarker. They will begin early treatment with anakinra in the effort to prevent progression in serious respiratory failure. Also due to the potential co-existing immunodysfunction in the context of SARS-CoV-2 infection patients will also receive trimethoprim/sulfamethoxazole as part of chemoprophylaxis.

NCT04357366 COVID-19 Virus Dis Virus Diseases Corona Virus Infection Lower Respiratory Tract Infection Viral Drug: Anakinra Drug: trimethoprim/sulfamethoxazole

MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency Virus Diseases

HPO:Respiratory tract infection

Primary Outcomes

Description: The primary study endpoint is the ratio of patients who will not develop serious respiratory failure SRF until day 14. Patients dying before study visit of day 14 are considered non-achieving the primary endpoint.

Measure: The ratio of patients who will not develop serious respiratory failure (SRF)

Time: Visit study day 14

Secondary Outcomes

Description: Evaluation of clinical data (pO2/FiO2 and need of mechanical ventilation) between baseline and study visit day 14 will be compared with historical comparators from Hellenic Sepsis Study Group Database

Measure: Comparison of the rate of patients who will not develop serious respiratory failure (SRF) until day 14 with historical comparators from Hellenic Sepsis Study Group Database

Time: Visit study day 14

Description: Change of scoring for respiratory symptoms (evaluation of cough, chest pain, shortness of breath and sputum) in enrolled subjects between days 1 and 7

Measure: Change of scoring for respiratory symptoms in enrolled subjects between days 1 and 7

Time: Visit study day 1, visit study day 7

Description: Change of scoring for respiratory symptoms (evaluation of cough, chest pain, shortness of breath and sputum) in enrolled subjects between days 1 and 14

Measure: Change of scoring for respiratory symptoms in enrolled subjects between days 1 and 14

Time: Visit study day 1, visit study day 14

Description: Change of Sequential organ failure assessment (SOFA) score of enrolled subjects between days 1 and 7 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)

Measure: Change of SOFA score in enrolled subjects between days 1 and 7

Time: Visit study day 1, visit study day 7

Description: Change of Sequential organ failure assessment (SOFA) score of enrolled subjects between days 1 and 14 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)

Measure: Change of Sequential organ failure assessment (SOFA) score in enrolled subjects between days 1 and 14

Time: Visit study day 1, visit study day 14

Description: Change of cytokine stimulation from peripheral blood mononuclear cells of enrolled subjects will be compared between days 1 and 7

Measure: Change of cytokine production between days 1 and 7

Time: Visit study day 1, visit study day 7

Description: Change of plasma inflammatory mediators measured levels will be compared between days 1 and 7

Measure: Change of plasma inflammatory mediators levels between days 1 and 7

Time: Visit study day 1, visit study day 7

262 Fibrinolytic Therapy to Treat ARDS in the Setting of COVID-19 Infection: A Phase 2a Clinical Trial

The global pandemic COVID-19 has overwhelmed the medical capacity to accommodate a large surge of patients with acute respiratory distress syndrome (ARDS). In the United States, the number of cases of COVID-19 ARDS is projected to exceed the number of available ventilators. Reports from China and Italy indicate that 22-64% of critically ill COVID-19 patients with ARDS will die. ARDS currently has no evidence-based treatments other than low tidal ventilation to limit mechanical stress on the lung and prone positioning. A new therapeutic approach capable of rapidly treating and attenuating ARDS secondary to COVID-19 is urgently needed. The dominant pathologic feature of viral-induced ARDS is fibrin accumulation in the microvasculature and airspaces. Substantial preclinical work suggests antifibrinolytic therapy attenuates infection provoked ARDS. In 2001, a phase I trial 7 demonstrated the urokinase and streptokinase were effective in patients with terminal ARDS, markedly improving oxygen delivery and reducing an expected mortality in that specific patient cohort from 100% to 70%. A more contemporary approach to thrombolytic therapy is tissue plasminogen activator (tPA) due to its higher efficacy of clot lysis with comparable bleeding risk 8. We therefore propose a phase IIa clinical trial with two intravenous (IV) tPA treatment arms and a control arm to test the efficacy and safety of IV tPA in improving respiratory function and oxygenation, and consequently, successful extubation, duration of mechanical ventilation and survival.

NCT04357730 Severe Acute Respiratory Syndrome Respiratory Failure Acute Respiratory Distress Syndrome Drug: Alteplase 50 MG [Activase] Drug: Alteplase 100 MG [Activase]

MeSH:Severe Acute Respiratory Syndrome Coron Coronavirus Infections Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Syndrome

Primary Outcomes

Description: Ideally, the PaO2/FiO2 will be measured with the patient in the same prone/supine position as in baseline, as change in positions may artificially reduce the improvement attributable to the study drug. However, given the pragmatic nature of the trial, the prone/supine position will be determined by the attending physician, in which case, we will use as an outcome the PaO2/FiO2 closest to the 48 hours obtained prior to the change in position as the outcome.

Measure: PaO2/FiO2 improvement from pre-to-post intervention

Time: at 48 hours post randomization

Secondary Outcomes

Description: Achievement of PaO2/FiO2 ≥ 200 or 50% increase in PaO2/FiO2 (whatever is lower)

Measure: Achievement of PaO2/FiO2 ≥ 200 or 50% increase in PaO2/FiO2

Time: at 48 hours post randomization

Description: This score is based on seven clinical features (respiration rate, hypercapnic respiratory failure, any supplemental oxygen, temperature, systolic blood pressure, heart rate and level of consciousness) and determines the degree of illness of a patient and prompts critical care intervention.

Measure: National Early Warning Score 2 (NEWS2)

Time: at 48 hours post randomization

Description: The ordinal scale is an assessment of the clinical status as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. (combined items 7 and 8 as our study is limited to hospital).

Measure: National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale

Time: at 48 hours post randomization

Description: 48 hour mortality for hospitalized patients

Measure: 48 hour in-hospital mortality

Time: at 48 hours post randomization

Description: 14 days mortality for hospitalized patients

Measure: 14 days in-hospital mortality

Time: 14 days post randomization

Description: 28 days mortality for hospitalized patients

Measure: 28 days in-hospital mortality

Time: 28 days post randomization

Description: ICU-free days will be calculated based on (28 - number of days spent in the ICU) formula

Measure: ICU-free days

Time: 28 days of hospital stay or until hospital discharge (whichever comes first)

Description: In-hospital coagulation-related events include bleeding, stroke, myocardial infarction and venous thromboembolism (VTE). In-hospital coagulation-related event-free (arterial and venous) days will be calculated based on (28 - number of days without coagulation-related event) formula.

Measure: In-hospital coagulation-related event-free (arterial and venous) days

Time: 28 days of hospital stay or until hospital discharge (whichever comes first)

Description: Ventilator-free days will be calculated based on (28 - number of days on mechanical ventilation) formula.

Measure: Ventilator-free days

Time: 28 days of hospital stay or until hospital discharge (whichever comes first)

Description: Calculated for patients who was on a mechanical ventilation any period of time during hospitalization. The extubation will be considered successful if no re-intubation occurred for more than 3 days have passed after the initial extubation.

Measure: Successful extubation

Time: Day 4 after initial extubation

Description: Calculated for patients who was on paralytics at the time of randomization. The weaning will be considered successful if no paralytics were used for more than 3 days have passed after termination of paralytics.

Measure: Successful weaning from paralysis

Time: Day 4 after initial termination of paralytics

Description: Is counted for the patients who was alive at the time of discharge.

Measure: Survival to discharge

Time: 28 days of hospital stay or until hospital discharge (whichever comes first)

263 Administration of Intravenous Vitamin C in Novel Coronavirus Infection and Decreased Oxygenation (AVoCaDO): A Phase I/II Safety, Tolerability, and Efficacy Clinical Trial

Previous research has shown that high dose intravenous vitamin C (HDIVC) may benefit patients with sepsis, acute lung injury (ALI), and the acute respiratory distress syndrome (ARDS). However, it is not known if early administration of HDIVC could prevent progression to ARDS. We hypothesize that HDIVC is safe and tolerable in Coronavirus disease 2019 (COVID-19) subjects given early or late in the disease course and may reduce the risk of respiratory failure requiring mechanical ventilation and development of ARDS along with reductions in supplemental oxygen demand and inflammatory markers.

NCT04357782 COVID-19 Hypoxia Drug: L-ascorbic acid

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Hypoxia

HPO:Hypoxemia

Primary Outcomes

Description: Occurrence of adverse events during study drug infusion

Measure: Incidence of adverse events

Time: Days 1-4

Description: Occurrence of serious adverse events during study drug infusion

Measure: Incidence of serious adverse reactions

Time: Days 1-4

Description: Occurrence of adverse reactions during study drug infusion

Measure: Incidence of adverse reactions

Time: Days 1-4

Secondary Outcomes

Description: Documented days free off mechanical ventilation the first 28 days post enrollment

Measure: Ventilator-free days

Time: Days 1-28

Description: Documented days free of ICU admission the first 28 days post enrollment

Measure: ICU-free days

Time: Days 1-28

Description: Documented days free of hospital admission the first 28 days post enrollment

Measure: Hospital-free days

Time: Days 1-28

Description: Incidence of mortality at 28 days by all causes

Measure: All-cause mortality

Time: Days 1-28

Description: SpO2 (% peripheral oxygenation saturation) will be divided by fraction of inspired oxygen (FiO2) at start of study infusion and compared with S/F ratio at end of study infusion

Measure: Change in S/F ratio during HDIVC infusion

Time: Days 1-4

Description: The difference in serum CRP during HDIVC infusion reported in mg/dL

Measure: C-reactive protein (CRP)

Time: Days 1-4

Description: The difference in LDH during HDIVC infusion will be reported in IU/L

Measure: Lactate dehydrogenase (LDH)

Time: Days 1-4

Description: The difference in D-dimer during HDIVC infusion will be reported in ug/mL

Measure: D-dimer

Time: Days 1-4

Description: The difference in lymphocyte count during HDIVC infusion will be reported in 10e3/uL

Measure: Lymphocyte count

Time: Days 1-4

Description: The NLR will be calculated by dividing the absolute neutrophil count (10e3/uL) over the absolute lymphocyte count (10e3/uL) and ratio compared with Day 1 versus Day 4

Measure: Neutrophil to Lymphocyte ratio (NLR)

Time: Days 1-4

Description: The difference in serum ferritin will be calculated from the start of HDIVC infusion to day 4 and reported as ng/mL

Measure: Serum Ferritin

Time: Days 1-4

264 New Coronavirus Awareness

The following hypotheses were established in this study: H0: There is no difference in terms of COVID-19 in different age groups in Turkey. H1: There is a difference in terms of COVID-19 in different age groups in Turkey. It is known that social awareness is low because COVID-19 is a new virus. There are protective measures created based on scientific studies conducted during the epidemic, but there is no certainty about how much these measures are known to our society. Based on these aim of our study is that individuals in different age groups throughout Turkey to investigate and compare the new coronavirus awareness

NCT04357886 Healthy

MeSH:Coronavirus Infections

Primary Outcomes

Description: The questionnaire was prepared by the researchers. There are 49 questions in the survey and all of them are multiple choice. The survey assesses the demographic characteristics, awareness and attitudes of the participants towards the COVID-19.

Measure: COVID-19 Awareness Survey

Time: once at baseline of study

265 Risk Stratification With Chest Computed Tomography to Rule-out Suspected SARS-CoV-2 Infections of Unspecific Symptomatic Patients Before Hospital Admission

The study objective is to investigate the diagnostic value and consistency of chest CT as compared with comparison to RT-PCR assay in COVID-19 in patients which were stratified for hospital admission.

NCT04357938 Severe Acute Respiratory Syndrome Coronavirus 2 Device: CT-imaging

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Positive likelihood ratio (LR+) Negative likelihood ratio (LR-)

Measure: Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients who are to be admitted to hospital and who are rt-PCR negative for SARS-CoV-2.

Time: At hospital admission

Secondary Outcomes

Description: Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients with pulmonary comorbidities who are to be admitted to hospital and who are rt-PCR negative for SARS-CoV-2.

Measure: Sensitivity and specificity of chest CT in patients with pulmonary comorbidities

Time: At hospital admission

Description: Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients with cardiovascular comorbidities who are to be admitted to hospital and who are rt-PCR negative for SARS-CoV-2.

Measure: Sensitivity and specificity of chest CT in patients with cardiovascular comorbidities

Time: At hospital admission

Description: Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients with malignancy who are to be admitted to hospital and who are rt-PCR negative for infection with SARS-CoV-2.

Measure: Sensitivity and specificity of chest CT in patients with malignancy

Time: At hospital admission

Description: Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients with immunodeficiency who are to be admitted to hospital and who are rt-PCR negative for SARS-CoV-2.

Measure: Sensitivity and specificity of chest CT in patients with immunodeficiency

Time: At hospital admission

Other Outcomes

Description: Predictive value of chest CT

Measure: Predictive value of specific chest CT findings for detection of SARS-CoV-2

Time: At hospital admission

266 A Human Clinical Study to Collect Calibration and Performance Data for the RBA-2 Device

The current available diagnostic methods used for the detection of COVID-19 takes up to 4 hours. In some cases, these diagnostics tests make take up to a couple of days. As it is highly contagious, people who are in close contact with the infected person are at high risk of being infected. COVID-19 is transmitted through respiratory droplets produced when an infected person coughs or sneezes. The desire for rapid detection of COVID-19 has become an immediate necessity. The purpose of Kaligia Biosciences' saliva monitoring device (RBA-2) is to detect the presence of the COVID-19 virus in human saliva. The RBA-2 uses Raman Spectros-copy to detect the coronavirus. Once the sample is scanned successfully, the spectra contains the response of the component present in human saliva and provide results in a matter of minutes, rather than hours or days.

NCT04357977 Coronavirus COVID Diagnostic Test: RBA-2

MeSH:Coronavirus Infections

Primary Outcomes

Description: The comparison of the results obtained from the current testing methods will be used to calibrate machine learning algorithms of the RBA-2

Measure: Covid +

Time: 10 days

267 Expanded Access: Pulsed, Inhaled Nitric Oxide (iNO) for the Treatment of Patients With Mild or Moderate Coronavirus Disease (COVID-19)

The search for novel therapies to address the ongoing coronavirus (COVID-19) pandemic is ongoing. No proven therapies have been identified to prevent progression of the virus. Preliminary data suggest that inhaled nitric oxide (iNO) could have benefit in preventing viral progression and reducing reliance on supplemental oxygen and ventilator support. Expanded access allows for iNO to be delivered via the portable INOpulse delivery system for the treatment of COVID-19.

NCT04358588 Coronavirus Infection COVID-19 Pneumonia, Viral Drug: iNO (inhaled nitric oxide) delivered via the INOpulse Delivery System

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia

HPO:Pneumonia

268 Anxiety and Work Resilience Among Tertiary University Hospital Workers During the COVID-19 Outbreak: An Online Survey

For limiting COVID-19 spreading, the World Health Organisation (WHO) recommended worldwide confinement on 2010. In France, unessential institutions were closed on March 14th and population confinement was decided on March 17th. Quarantine and/or confinement could lead to psychological effects such as confusion, suicide ideation, post-traumatic stress symptoms or anger COVID-19 outbreak highlighted a considerable proportion of health care workers (HCW) with depression, insomnia, anxiety and distress symptoms. In front line, facing the virus with the fear of contracting it and contaminate their closest. During previous outbreaks (H1N1, SARS), HCWs have been shown to experience such negative psychological effects of confinement as well as work avoidance behaviour and physical interaction reduction with infected patients (4-7). In France, Covid 19 outbeak led to increase ICU bed capacity with a full reorganization of the human resources. Some caregivers were reassigned to newly setup units admitting or not Covid-19 patients. In the same time, non-caregivers were also encouraged to work at home whenever possible. Thus, every hospital staff member's private and professional life could be altered by the Covid-19 outbreak. As all these changes in the daily life could induce psychological disturbances, the present study was aimed at assessing the acute anxiety level (main objective) of the staff in our Tertiary University Hospital, (6300 employees). Secondarily, the self-reported insomnia, pain, catastrophism and work avoidance behaviour levels were assessed

NCT04358640 Critical Illness Sars-CoV2 SARS Pneumonia Coronavirus Infection Stress Disorders, Post-Traumatic

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Critical Illness Stress Disorders, Post-Traumatic

HPO:Pneumonia

Primary Outcomes

Description: Mesured by STAY Scale

Measure: Anxiety

Time: 15 to 45 days after the beginning of the outbreak

Secondary Outcomes

Description: Participant suffering of Insomnia

Measure: Insomnia

Time: 15 to 45 days after the beginning of the outbreak

Description: Participant suffering of catastrophism

Measure: Catastrophism

Time: 15 to 45 days after the beginning of the outbreak

269 Phase II, Randomized, Double-blind, Controlled Clinical Trial Evaluating the Efficacy and Safety of Plasma From Patients Cured of COVID-19 Compared to the Best Available Therapy in Subjects With SARS-CoV-2 Pneumonia

In early December 2019, cases of pneumonia of unknown origin were identified in Wuhan, China. The causative virus was called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The World Health Organization (WHO) has recently declared coronavirus disease 2019 (COVID-19) a public health emergency of international concern. According to the World Health Organization (WHO), the management of COVID-19 has focused primarily on infection prevention, detection and patient monitoring. However, there is no vaccine or specific treatment for SARS-CoV-2 due to the lack of evidence. Treatment options currently include broad-spectrum antiviral drugs but the efficacy and safety of these drugs is still unknown. Convalescent plasma has previously been used to treat various outbreaks of other respiratory infections; however, it has not been shown to be effective in all the diseases studied. Therefore, clinical trials are required to demonstrate its safety and efficacy in patients with VIDOC-19. The present work seeks to determine the mortality from any cause up to 14 days after plasma randomization of patients cured of COVID-19 compared to the Best Available Therapy in subjects with SARS-CoV-2 pneumonia. This is a 2:1 randomized, double-blind, single-center, phase 2, controlled clinical trial (plasma: best available therapy) for the treatment of SARS-CoV-2 pneumonia.

NCT04358783 Coronavirus Infection Biological: Plasma Other: Best Available Therapy

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: any cause mortality during the first 14 days of treatment

Measure: Early all-cause mortality

Time: 14 days

Secondary Outcomes

Description: (48-hour sampling interval from day 3 of hospitalization to two consecutive negatives).

Measure: Time in days for SARS-CoV-2 RT-PCR negatives

Time: 90 days

Description: In subjects of both arms at day 0, 3, 7, 14 and 90.

Measure: The serum anti-SARS-CoV-2 antibody titres

Time: 90 days

Description: Comparison of anti-SARS-CoV-2 antibody titers

Measure: Detection of serum antibodies

Time: days 0, 3, 7, 14 and 90.

270 The Effect of Prone Positioning on Lung Aeration and Ventilation-perfusion Matching in Mechanically Ventilated Patients With Coronavirus Disease Related Acute Respiratory Distress Syndrome

The consensus therapeutic strategy implies that COVID patients with acute lung injury due to coronavirus are routinely placed in prone position in an attempt to improve oxygenation by increasing ventilation homogeneity. The purpose of the study is to quantify with the electrical impedance tomography (EIT) the changes in the ventilation and aeration in the dorsal regions of the lung when the patient is placed in prone position.

NCT04359407 Severe Acute Respiratory Syndrome Coronavirus 2 Electric Impedance Prone Positioning Other: Prone positioning

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Syndrome

Primary Outcomes

Description: Change in the ratio of tidal electrical impedance variation in the dorsal and total lung areas

Measure: Tidal electrical Impedance

Time: One hour before turning to prone or supine positioning

Secondary Outcomes

Description: Changes in intrapulmonary shunt fraction

Measure: Intrapulmonary shunt

Time: One hour before turning to prone or supine positioning

Description: Changes in the phase three slope of the volumetric capnogram

Measure: Volumetric capnography

Time: One hour before turning to prone or supine positioning

271 A Phase 2, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Human Anti-SARS-CoV-2 Convalescent Plasma in Severely Ill Adults With COVID-19

This randomized blinded phase 2 trial will assess the efficacy and safety of Anti-SARS-CoV-2 convalescent plasma among adults with severe COVID-19. Adults ≥18 years of age may participate. A total of 105 eligible subjects will be randomized in a 2:1 ratio to receive either high-titer anti-SARS-CoV-2 plasma or non-convalescent fresh frozen plasma (control plasma).

NCT04359810 SARS-CoV Infection Biological: Convalescent Plasma (anti-SARS-CoV-2 plasma) Biological: Non-convalescent Plasma (control plasma)

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The efficacy of treatment will be determined by determining the time-to-clinical improvement, defined as the time from randomization to either an improvement of one point on a seven-category ordinal scale or alive discharge from the hospital, whichever comes first.

Measure: Time to Improvement

Time: Up to 28 days

Secondary Outcomes

Description: Compare the rates of SARS-CoV-2 PCR positivity (RT PCR) amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups.

Measure: Rate of SARS-CoV-2 PCR Positivity

Time: Up to 14 days

Description: Compare the duration of SARS-CoV-2 PCR positivity (RT PCR) amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups.

Measure: Duration of SARS-CoV-2 PCR Positivity

Time: Up to 14 days

Description: Compare duration of need for supplemental oxygen and/or mechanical ventilation amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups.

Measure: Duration of Need for Supplemental Oxygen

Time: Up to 28 days

Description: Compare duration of hospitalization amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups.

Measure: Duration of Hospitalization

Time: Up to 28 days

Description: Compare in-hospital and 28-day mortality amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups.

Measure: In-hospital 28-day Mortality Rate

Time: Up to 28 days

272 A Non-Interventional Pilot Study to Explore the Role of Gut Flora in COVID-19 Infection

This study seeks to determine whether the virus which causes COVID-19, SARS-CoV-2, is shed in the stools of patients who are infected.

NCT04359836 Gut Microbiome Gastrointestinal Microbiome COVID COVID-19 Corona Virus Infection Coronavirus Coronaviridae Infections Coronavirus 19 Coronavirus-19 COVID 19 Other: There is no intervention in this study

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Coronaviridae Infections

Primary Outcomes

Description: Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific gastrointestinal disease types.

Measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing

Time: One year

Secondary Outcomes

Description: To validate the methods used to sequence samples

Measure: Validation of Sequencing Methods

Time: One year

273 Sequencing and Tracking of Phylogeny in COVID-19 Study

We plan to generate a database of viral RNA sequences for SARS-CoV-2 within the Wessex region. Such whole genome data can be used to monitor mutation rates in real time and, through comparison with global databases of SARS-CoV-2 genome sequences, can be used to map transmission of the virus

NCT04359849 Coronavirus Infection

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Generated using Nanopore-based whole genome sequencing techniques

Measure: To produce whole genome sequences for the SARS-CoV-2 virus from viral RNA samples

Time: 2 years

Secondary Outcomes

Description: Identify mutations and viral strains prevalent within the Wessex region

Measure: To develop a phylogenetic map of the SARS-CoV-2 virus

Time: 2 years

274 Impact of Levamisole and Isoprinosine in Immune-prophylaxis of Egyptian Healthcare Workers Facing COVID-19

This randomized open labeled clinical trial will include one hundred healthy healthcare workers who will be randomly assigned into four groups of twenty-five each to receive either levamisole, Isoprinosine, combined levamisole and isoprinosine or no-intervention for two months to detect the impact of Levamisole and Isoprinosine as immune-prophylaxis on the incidence of COVID-19 infection. Participants will be followed-up for three months clinically and laboratory. Blood samples will be collected prior to randomization and during follow up.

NCT04360122 Coronavirus Disease (COVID-19) Drug: Levamisole Drug: Isoprinosine Drug: Levamisole and Isoprinosine

MeSH:Coronavirus Infections

Primary Outcomes

Description: Detect if Levamisole and Isoprinosine can decrease the incidence of COVID-19 infection

Measure: Decrease the incidence of COVID-19 infection or its severity

Time: 6 months

275 Expanded Access Protocol For The Treatment Of CORONAVIRUS DISEASE 2019 (COVID-19) With Anti-Sars-CoV-2 Convalescent Plasma (ASCoV2CP)

This treatment protocol is designed to provide a treatment option for patients diagnosed with severe or life-threatening COVID-19 or judged by the subinvestigator (treating physician) to be at high risk of progressing to severe or life threatening disease

NCT04360486 Severe Acute Respiratory Syndrome Coronavirus 2 Other: Anti-Sars-CoV-2 Convalescent Plasma

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

276 Long Term Outcomes of Patients With COVID-19

The investigators hypothesize that those with respiratory failure due to COVID-19 will have different burdens of mental and physical disability than those with respiratory failure who do not have COVID-19. Detecting these potential differences will lay an important foundation for treating long term sequelae of respiratory failure in these two cohorts.

NCT04360538 Critical Illness Corona Virus Infection Respiratory Failure Covid-19 Other: Quality of Life Other: Impact Event Score Other: Hospital anxiety and depression scale

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency Critical Illness

Primary Outcomes

Description: SF-36 score

Measure: Quality of Life score

Time: up to 12 months after discharge

Secondary Outcomes

Description: Montreal Cognitive Assessment (MoCA) score

Measure: cognitive dysfunction

Time: up to 12 months after discharge

Description: (FSS-ICU)

Measure: Functional Status Score

Time: up to 12 months after discharge

Description: MRC neuromuscular Assessment

Measure: Physical Disability

Time: up to 12 months after discharge

Description: Impact Event Score

Measure: Psychological Sequelae

Time: up to 12 months after discharge

Other Outcomes

Description: hospital anxiety and depression scale

Measure: hospital anxiety and depression

Time: up to 12 months after discharge

Description: including ventilator associated pneumonia, GI hemorrhage, Deep Vein Thrombosis (DVT) /Pulmonary Embolus (PE), sacral decubitus ulcer, delirium, ICU acquired weakness

Measure: ICU related complications

Time: hospitalization up to 6 weeks

Description: measure the location (home, rehabilitation center, nursing home

Measure: hospital discharge location

Time: hospital discharge up to 6 weeks

Description: number of days admitted to the ICU

Measure: lCU length of stay

Time: hospitalization up to 6 weeks

Description: number of days admitted to the hospital

Measure: hospital length of stay

Time: hospitalization up to 6 weeks

277 Evaluation of Commerical Antibody Tests for COVID-19

The purpose of this study is to evaluate the sensitivity and specificity of several marketed commercial or prototype test kits for antibody to SARS-CoV-2. The focus will be on rapid-format, point-of-care antibody test kits that detect both IgM and IgG antibodies to recombinant viral proteins. Note: No voluntary enrolment into this study will be conducted; all testing is to be conducted anonymously.

NCT04360954 COVID Coronavirus Diagnostic Test: Diagnostic test

MeSH:Coronavirus Infections

Primary Outcomes

Description: Test sensitivity relative to RT-PCR for acute samples; sensitivity relative to ELISA for convalescent samples.

Measure: Test Sensitivity

Time: 2020

Description: Percent positivity with pre-COVID samples

Measure: Test Specificity

Time: 2020

278 A Prospective Study of COVID-19 Using Real-Time Syndromic Surveillance, Scheduled At-home Serologic Testing, and Electronic Health Records

The purpose of this research is to collect information about coronavirus exposures, symptoms, and health care visits due to the among Atrium Health clients and health care workers. Participation in this study will involve completing a daily questionnaire which covers participants coronavirus illness history or symptoms, health care seeking behaviors and treatments, contact with other sick people, and for health care workers, their use of personal protective equipment.

NCT04361123 Coronavirus COVID Other: daily syndromic surveillance Diagnostic Test: monthly serologic IgM/G test

MeSH:Coronavirus Infections

Primary Outcomes

Description: Percent of volunteers who are 2019-nCoV Ab test positive

Measure: Seroprevalence of SARS-CoV-2 infection in the general population of North Carolina

Time: baseline

Description: Percent of volunteers who are 2019-nCoV Ab test positive

Measure: Seroprevalence of SARS-CoV-2 infection among health care workers of North Carolina

Time: baseline

Secondary Outcomes

Measure: Cumulative incidence of SARS-CoV-2 infection

Time: 12 month

Measure: Monthly incidence of SARS-CoV-2 infection

Time: Month 1 thru month 12

Measure: Stratified incidence of SARS-CoV-2 infection by age group

Time: Month 1 thru month 12

Measure: Stratified incidence of SARS-CoV-2 infection by sex

Time: Month 1 thru month 12

Measure: Stratified incidence of SARS-CoV-2 by season

Time: Month 1 thru month 12

Measure: Stratified incidence of SARS-CoV-2 infection by geographic area (zip code)

Time: Month 1 thru month 12

Measure: Stratified incidence of SARS-CoV-2 infection by preexisting comorbidities

Time: Month 1 thru month 12

Measure: Stratified incidence of SARS-CoV-2 infection by COVID-2 contacts

Time: Month 1 thru month 12

Measure: •Stratified incidence of SARS-CoV-2 infection by use of personal protective equipment (PPE) by health workers

Time: Month 1 thru month 12

Measure: Relative risk of SARS-CoV-2 infection by age group

Time: Month 1 thru month 12

Measure: Relative risk of SARS-CoV-2 infection by sex

Time: Month 1 thru month 12

Measure: Relative risk of SARS-CoV-2 infection by season

Time: Month 1 thru month 12

Measure: Relative risk of SARS-CoV-2 infection by geographic area (zip code)

Time: Month 1 thru month 12

Measure: Relative risk of SARS-CoV-2 infection by preexisting comorbidities

Time: Month 1 thru month 12

Measure: Relative risk of SARS-CoV-2 infection by COVID-2 contacts

Time: Month 1 thru month 12

Measure: Relative risk of SARS-CoV-2 infection by use of PPE by health workers

Time: Month 1 thru month 12

Measure: Incidence of sequelae

Time: Month 1 thru month 12

279 Assessment of the Presence of the SARS-COV-2 Virus in the Peritoneum During an Emergency Laparoscopy Conducted on Confirmed or Suspected COVID-19 Patients

The purpose of this study is to determine whether the virus SARS-CoV-2, responsible for the disease COVID-19, is present in the abdominal cavity during emergency laparoscopic exploration in confirmed or suspected COVID-19 patients.

NCT04361396 Coronavirus Infection Other: Collection of samples

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Assessment of the presence of the SARS-COV-2 virus by RT-PCR in the peritoneum at the end of the surgical procedure with exsufflation (T4) in COVID-19 patients

Measure: Assessment of the presence of the SARS-COV-2 virus at T4

Time: After surgery, an average of half a day

Secondary Outcomes

Description: Assessment of the presence of the SARS-COV-2 virus by RT-PCR immediately after creation of the pneumoperitoneum just before intraperitoneal surgical exploration (T1) in COVID-19 patients

Measure: Assessment of the presence of the SARS-COV-2 virus at T1

Time: After surgery, an average of half a day

Description: Assessment of the presence of the SARS-COV-2 virus by RT-PCR in the peritoneal effusion found during surgical exploration (T2) or in the peritoneal lavage fluid at the end of the surgical procedure before exsufflation (T4) in COVID-19 patients

Measure: Assessment of the presence of the SARS-COV-2 virus in the peritoneal effusion at T2 or T4

Time: After surgery, an average of half a day

Description: Assessment of the presence of the SARS-COV-2 virus by RT-PCR in the pneumoperitoneum during intraperitoneal surgical dissection (T2) with straight blunt/sharp or any kind of energy devices in COVID-19 patients

Measure: Assessment of the presence of the SARS-COV-2 virus at T3

Time: After surgery, an average of half a day

Description: Assessment of the presence of the SARS-COV-2 virus by RT-PCR in the bile at the end of the intervention after specimen extraction (T5), in case a cholecystectomy is performed in COVID-19 patients

Measure: Assessment of the presence of the SARS-COV-2 virus at T5

Time: After surgery, an average of half a day

280 Hydroxychloroquine or Hydroxychloroquine Associated With Azithromycin for Inpatients With Moderate or Severe Lung Disease Due to SARS-CoV-2 (COVID-19)

The Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV2) has been identified in Wuhan, China, which causes severe pulmonary complications and flu syndrome, which has spread rapidly to all continents. Approximately 25% of hospitalized patients require treatment in intensive care units and 10% require mechanical ventilation. The diagnosis is made by the molecular polymerase chain reaction test. However, diagnostic tests are limited. The clinical care of the patient with COVID-19 is similar to that of patients with severe infectious respiratory complications, consisting of support and oxygen supplementation. Several medications have been tested as remdesivir, a pro-drug nucleoside, which acts by inhibiting viral RNA transcription, although a recently published study has shown no benefit. China recently approved the use of favipiravir, an antiviral used for influenza, as an experimental therapy for COVID-19. Hydroxychloroquine is a drug with great potential treatment, as it can inhibit the pH-dependent steps of replication of various viruses, with a potent effect on SARS-CoV infection and spread. In this way, the present study will evaluate the safety and efficacy of the hydroxychloroquine in patients with symptomatic SARS-Cov2.

NCT04361461 Coronavirus Infections SARS-CoV 2 SARS (Severe Acute Respiratory Syndrome) Pulmonary Disease Drug: Hydroxychloroquine Sulfate Drug: Hydroxychloroquine Sulfate + Azythromycin

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The individual response rate regarding the World Health Organization Ordinal Scale assessment from basal to 14th Day.

Measure: Individual response rate

Time: 14 days after randomization

Secondary Outcomes

Description: All-cause mortality rates at Day 28th after randomization

Measure: All-cause mortality

Time: 28 days after randomization

Description: Number of days that the patient was on mechanical ventilation which was under ventilation from basal line

Measure: Duration of mechanical ventilation

Time: baseline

Description: Proportion of patients who do not receive mechanical ventilation at the beginning of the study and then needed mechanical ventilation during hospitalization.

Measure: Proportion of patients which needed mechanical ventilation during study

Time: hospitalization within 28 days

Description: The ordinal scale is an assessment of the clinical status at the first clinical evaluation in a clinical study. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.

Measure: World Health Organization (WHO) Ordinal scale

Time: 28 days after inclusion and compared to baseline

Description: Length of hospital stay in days for hospitalization

Measure: Duration of hospitalization

Time: hospitalization within 28 days

Description: Rates of drug discontinuation in all causes under study

Measure: Rates of drug discontinuation

Time: hospitalization within 28 days

Other Outcomes

Description: Rates of serious adverse events

Measure: Rates of serious adverse events

Time: Day 14th

281 Pilot Study on Cytokine Filtration in COVID-19 ARDS (CytokCOVID19)

Background: There are no proven therapies for COVID-19 infection. COVID-19 infects the respiratory epithelium of the lower airways, causing widespread damage via cytopathic effects, resulting in severe inflammation and Pneumonitis. High local and circulating levels of cytokines, or cytokine storm, can lead to capillary leak syndrome, progressive lung injury, respiratory failure and acute respiratory distress syndrome (ARDS). Methods: This is a pilot randomized, controlled, uni-center study testing safety and efficacy of cytokine filtration on patients with severe ARDS. Eligible patients will be randomized to 72 hours filtration or no filtration on top of the standard treatment for ARDS. Indications for randomization are patients with moderate or severe ARDS with need of ventilation support (either invasive or non-invasive), with inflammatory markers. The primary outcome will be days on mechanical ventilation (MV) support. Secondary outcomes are 30-day mortality, ICU days, need for extracorporeal membrane oxygenation (ECMO) support, duration of renal replacement therapy (RRT) and catecholamine therapies, hospital length of stay, multi-organ failure. All analysis will be done according to the intention to treat principle.

NCT04361526 Coronavirus Infection Acute Respiratory Distress Syndrome COVID Device: Cytokine Adsorption

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: Number of ventilator-free days (VFDs) at day 28 (defined as days being alive and free from mechanical ventilation at day 28 after enrollment. For patients ventilated 28 days or longer and for ventilated subjects who die, VFD is 0

Measure: Mechanical ventilation-free days

Time: up to 28days

Secondary Outcomes

Measure: 30-day mortality

Time: up to 30 days

Measure: length of ICU stay (days)

Time: up to 30 days

Measure: length of hospital stay

Time: up to 30 days

Measure: Duration of renal replacement and cathecolamines therapies

Time: up to 30 days

Measure: Need for extracorporeal membrane oxygenation (ECMO) support

Time: up to 30 days

Measure: multi-organ failure measured by the Sequential Organ Failure Assessment (SOFA) score

Time: up to 30 days (measured on days 0, 1, 2, 3, 4, 5, 6, and the last day of mechanical ventilation)

282 Impact of Multi-Denominational Prayer on Morbidity and Mortality of Patients Admitted to the Intensive Care Unite With Corona Virus Infection

This is a multicenter; double blind randomized controlled study investigating the role of remote intercessory multi-denominational prayer on clinical outcomes in COVID-19 + patients in the intensive care unit. All patients enrolled will be randomized to use of prayer vs. no prayer in a 1:1 ratio. Each patient randomized to the prayer arm will receive a "universal" prayer offered by 5 religious denominations (Christianity, Hinduism, Islam, Judaism and Buddhism) in addition to standard of care. Whereas the patients randomized to the control arm will receive standard of care outlined by their medical teams. During ICU stay, patients will have serial assessment of multi-organ function and APACHE-II/SOFA scores serial evaluation performed on a daily basis until discharge. Data assessed include those listed below.

NCT04361838 Coronavirus Infection Behavioral: prayer

MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: This study will measure the difference in mortality of COVID-19 patients who are admitted to ICU - given prayer vs no prayer as an adjunct to standard therapy.

Measure: Impact of multi-denominational prayer on clinical outcomes of critically ill COVID-19 patients in the Intensive Care Unit on mortality.

Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 days

Secondary Outcomes

Description: APACHE II uses 0-71 scale, the higher the score the higher the risk for mortality.

Measure: Difference in patient outcomes - Acute Physiology and Chronic Health Enquiry. APACHE II score.

Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 days.

Description: The higher the SOFA score the increased likelihood of organ failure.

Measure: Difference in patient outcomes - Sequential Organ Failure Assessment - SOFA Score

Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 days

Description: A prolonged length of time in ICU increases mortality.

Measure: Difference in patient outcomes - Length of stay in ICU.

Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 days

Description: A prolonged length of time with ventilator support increases mortality.

Measure: Difference in patient outcomes - Length of ventilator support

Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 days

Description: A prolonged length of time with vasopressor support increases recovery time.

Measure: Difference in patient outcomes - length of vasopressor support

Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 days

283 COVID-19: Ruxolitinib for the Treatment of cytokinE Storm resPiratory dIstREss Syndrome. RESPIRE Study

It is an observational, cohort, retrospective, monocentric, non-profit study. The primary objective is to evaluate the efficacy and safety of ruxolitinib in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours.

NCT04361903 Severe Acute Respiratory Syndrome Coronavirus 2 Drug: Ruxolitinib Oral Tablet

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Syndrome

Primary Outcomes

Description: Number of patients who avoid mechanical assisted ventilation in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours

Measure: Number of patients who avoid mechanical assisted ventilation in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19

Time: 15 days

Secondary Outcomes

Description: ABG (arterial Blood Gas): pH as SI Unit, every 12 hours and in any case in the presence of significant clinical variations.

Measure: Improvement of respiratory performance - Arterial Blood Gas Analisys - pH

Time: 15 days

Description: ABG (arterial Blood Gas): pO2 in mm Hg, every 12 hours and in any case in the presence of significant clinical variations.

Measure: Improvement of respiratory performance - Arterial Blood Gas Analisys - pO2

Time: 15 days

Description: ABG (arterial Blood Gas): pCO2 in mm Hg, every 12 hours and in any case in the presence of significant clinical variations.

Measure: Improvement of respiratory performance - Arterial Blood Gas Analisys - pCO2

Time: 15 days

Description: PaO2 / FiO2, SatO2 ratio. Vital parameters and respiratory function every 12 hours and in any case in the presence of significant clinical variations.

Measure: Improvement of respiratory performance - ratio values

Time: 15 days

Description: every 24 hours D-Dimer value in mgr/ml

Measure: Evaluation of known adverse events related to the use of the drug - D-Dimer

Time: 15 days

Description: every 24 hours fibrinogen value in mg/dl

Measure: Evaluation of known adverse events related to the use of the drug - fibrinogen

Time: 15 days

Description: every 24 hours transaminases value in U/L

Measure: Evaluation of known adverse events related to the use of the drug - transaminases

Time: 15 days

Description: every 24 hours aPTT value in seconds

Measure: Evaluation of known adverse events related to the use of the drug - aPTT

Time: 15 days

Description: every 24 hours INR value in %

Measure: Evaluation of known adverse events related to the use of the drug - INR

Time: 15 days

Description: every 24 hours glycemia value in mg/dl

Measure: Evaluation of known adverse events related to the use of the drug - glycemia

Time: 15 days

Description: every 24 hours creatinine serum value in mg/dl

Measure: Evaluation of known adverse events related to the use of the drug - creatinine

Time: 15 days

Description: Total leucocyte as CBC x10e)/L

Measure: Evaluation of known adverse events related to the use of the drug - Leucocytes count

Time: 15 days

Description: formula % on total leucocyte

Measure: Evaluation of known adverse events related to the use of the drug - Leucocytes formula

Time: 15 days

Description: Thoracic imaging, every 48 h: presence, extension and dimension on lung thickening - Chest CT at start and end of treatment, Time elapsed between the onset of clinical symptoms and hospitalization.

Measure: Evaluation of the epidemiological parameters: Chest CT

Time: 15 days

Description: Thoracic imaging: every day: presence and number of line B every 48 hours.Time elapsed between the onset of clinical symptoms and hospitalization.

Measure: Evaluation of the epidemiological parameters: Eco Chest

Time: 15 days

Description: Thoracic imaging: presence, extension and dimension on lung thickening - Chest X-ray, Time elapsed between the onset of clinical symptoms and hospitalization.

Measure: Evaluation of the epidemiological parameters: CHEST X-ray

Time: 15 days

Description: Monitoring of serum cytokines (IL-6 in pgr/dL, TNF in pgr/dL) every 48 h

Measure: Monitoring of Serum levels of cytokines before and every 48 h from start to to end of treatment

Time: 15 days

Description: Number of AE grade 1 to 4

Measure: Monitoring incidence of treatment Emergent Adverse Events of ruxolitinib therapy

Time: 15 days

284 Long-term Impact of Infection With Novel Coronavirus (LIINC): An Observational Study

LIINC is a study of volunteers who were previously infected with SARS-CoV-2 (also known as novel coronavirus or COVID-19) who have recovered from acute infection. The study is designed to provide a specimen bank of samples with carefully characterized clinical data. LIINC specimens will be used to examine multiple questions involving the virologic, immunologic, and host factors involved in COVID-19, with a focus on understanding variability in the long-term immune response between individuals.

NCT04362150 COVID

MeSH:Coronavirus Infections

Primary Outcomes

Description: The median age of study participants at enrollment.

Measure: Participant age

Time: Baseline visit

Description: The proportion of men and women participating in the baseline visit.

Measure: Participant sex

Time: Baseline visit

Description: The proportion of participants from each demographic group.

Measure: Participant race/ethnicity

Time: Baseline visit

Description: The proportion of participants who were previously hospitalized.

Measure: Proportion of participants previously hospitalized.

Time: Baseline visit

285 A Randomized, Controlled Clinical Trial to Test the Safety and Efficacy of Convalescent Donor Plasma to Treat COVID-19 in Hospitalized Adults

The purpose of this study is to test the safety and efficacy of convalescent donor plasma to treat COVID-19 in hospitalized adults in a randomized, placebo-controlled setting. The effect of convalescent plasma will be compared to placebo on clinical outcomes, measured using the COVID Ordinal Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization.

NCT04362176 COVID-19 Coronavirus SARS-CoV-2 Biological: pathogen reduced SARS-CoV-2 convalescent plasma Biological: Placebo

MeSH:Coronavirus Infections

Primary Outcomes

Description: Death Hospitalized on invasive mechanical ventilation or ECMO Hospitalized on non-invasive ventilation or high flow nasal cannula Hospitalized on supplemental oxygen Hospitalized not on supplemental oxygen Not hospitalized with limitation in activity (continued symptoms) Not hospitalized without limitation in activity (no symptoms)

Measure: COVID Ordinal Outcomes Scale:Day 15

Time: Study Day 15

Secondary Outcomes

Description: All-location, all-cause 14-day mortality

Measure: All-location, all-cause 14-day mortality

Time: Baseline to Study Day 14

Description: All-location, all-cause 28-day mortality

Measure: All-location, all-cause 28-day mortality

Time: Baseline to Study Day 28

Measure: COVID Ordinal Outcomes Scale Day 3

Time: Baseline to Study Day 3

Measure: COVID Ordinal Outcomes Scale Day 8

Time: Study Day 8

Measure: COVID Ordinal Outcomes Scale Day 29

Time: Study Day 29

Description: Number of participants that died or received ECMO

Measure: Composite of death or receipt of ECMO through Day 28

Time: Baseline to Day 28

Description: Number of days without use of oxygen

Measure: Oxygen-free days through Day 28

Time: Baseline to Day 28

Description: Number of days without use of vasopressors

Measure: Vasopressor-free days through Day 28

Time: Baseline to Day 28

Description: Number of days without use of a ventilator

Measure: Ventilator-free days through Day 28

Time: Baseline to Day 28

Description: Number of days outside of ICU

Measure: ICU-free days through Day 28

Time: Baseline to Day 28

Description: Number of days outside of the hospital

Measure: Hospital-free days through Day 28

Time: Baseline to Day 28

Other Outcomes

Description: Number of participants with Acute kidney injury

Measure: Acute kidney injury

Time: Baseline to Day 28

Description: Number of participants requiring renal replacement therapy

Measure: Renal replacement therapy

Time: Baseline to Day 28

Description: Number of participants with documented venous thromboembolic disease (DVT or PE)

Measure: Documented venous thromboembolic disease (DVT or PE)

Time: Baseline to Day 28

Description: Number of Participants with myocardial infarction or ischemic stroke

Measure: Documented cardiovascular event (myocardial infarction or ischemic stroke)

Time: Baseline to Day 28

Description: Number of participants with transfusion reaction (fever/rash)

Measure: Transfusion reaction

Time: Baseline to Day 28

Description: Number of participants with transfusion related acute lung injury (TRALI)

Measure: Transfusion related acute lung injury (TRALI)

Time: Baseline to Day 28

Description: Number of participants with transfusion associated circulatory overload (TACO)

Measure: Transfusion associated circulatory overload (TACO)

Time: Baseline to Day 28

Description: Number of participants with transfusion related infection

Measure: Transfusion related infection

Time: Baseline to Day 28

286 SJTRC-St. Jude Tracking of Viral and Host Factors Associated With COVID-19: A Prospective Adaptive Cohort Study

This is a prospective adaptive cohort study of St. Jude employees to determine the rate of SARS-CoV-2 infections that are asymptomatic and to evaluate immunological responses to SARS-CoV-2 infection. Primary Objectives - To estimate the proportion of asymptomatic infection with SARS-CoV-2 infection in a population of SARS-CoV-2-naïve adult St. Jude employees - To comprehensively map CD4 and CD8 T cell epitopes and response magnitudes to SARS-CoV-2 infection in a population of SARS-CoV-2-naïve adult St. Jude employees who acquire SARS-CoV-2 infection Secondary Objectives - To establish seroprevalence of SARS-CoV-2-specific antibodies at baseline, and identify the rate of seroconversion to SARS-CoV-2 in a population of presumably naïve adult St. Jude employees - To identify features of T cell responses at baseline and during SARS-CoV-2 infection that are associated with protection against symptomatic or severe COVID-19 disease in a population of adult St. Jude employees Exploratory Objectives - To establish additional immunological features including host immune or receptor polymorphisms associated with response to SARS-CoV-2 infection - To explore SARS-CoV-2 diversity and specific features in a circumscribed population - To describe the presence, characteristics, and proportion of short-term re-infection - To determine if an association between SARS-CoV-2 viral load in nasal swab specimens and COVID-19 symptoms can be identified in a population of adult St. Jude employees who acquire SARS-CoV-2

NCT04362995 COVID-19 Coronavirus Infection Coronavirus SARS-CoV-2

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The proportion of participants who test positive for SARS-CoV-2 infection but remain asymptomatic.

Measure: Proportion of asymptomatic subjects

Time: 1 year from enrollment

Description: A list of CD4 and CD8 cell epitopes with a magnitude change from baseline that is at least twice the standard deviation of the baseline.

Measure: Positive CD4 and CD8 cell epitope positive response

Time: at enrollment, 3 months, 6 months, 9 months and 1 year

Secondary Outcomes

Description: The proportion of participants at each time point who have detectable antibodies that recognize SARS-COV-2.

Measure: Proportion of seroprevalence

Time: Baseline, 3 months, 6 months, 9 months and 1 year

Description: For CD8s, T cell responses will be categorized as cytolytic, cytokine producing, or exhausted. For CD4s they will be grouped as Th1, Th2, Tfh, or Th17. Percentages of cells in each category will be summarized at baseline and during SARS-CoV-2 infection.

Measure: T-cell response

Time: Baseline, 3 months, 6 months, 9months and 1 year

287 ACCESS (American COVID-19 Collaborative, Enabling Seamless Science) Master Digital Surveillance and Associated Clinical Trials Protocol for COVID-19

ACCESS enables individuals to contribute to critical research, via an iOS and Android smartphone mobile application. ACCESS combines patient reported outcomes, data from wearable devices and real-world data (such as claims, EHRs, etc), with an opt-in to participate in current and future studies for diagnostics, treatments and vaccines. The data that people share can be quickly and anonymously matched to research studies, providing researchers with a foundational framework for dynamic research at scale and participants a way to be personally matched and prescreened for future research.

NCT04363268 Coronavirus COVID COVID-19 COVID19 Corona Virus Infection Coronavirus Infection

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: To use multifaceted participant data consisting of participant reported outcomes, environmental surface and presence or absence of COVID-19 based on testing results, prescription medications (including off-label use), claims, lab, and medical record data to develop population-based models of disease risk, short and long-term outcomes, and efficacy of interventions and prevention measures.

Measure: Development of population-based models of disease risk

Time: Up to 10 years

Description: To leverage geolocation and lab results to provide population-level real-time data regarding disease burden at the community, state and national levels.

Measure: Relation between disease burden and geolocation

Time: Up to 10 years

Description: To specifically identify medications and regimens that address disease symptoms

Measure: Effect of medications on symptoms of COVID19

Time: Up to 10 years

Description: To specifically identify medications and regimens that treat and reduce disease severity.

Measure: Effect of medications on disease severity of COVID19

Time: Up to 10 years

Secondary Outcomes

Description: To identify regional variations in disease incidence and outcomes.

Measure: Rate of COVID19 infection and disease outcomes

Time: Up to 10 years

Description: To understand long-term outcomes such as risk of pulmonary and cardiovascular disease complications.

Measure: Effect of COVID19 on health outcomes

Time: Up to 10 years

Description: To conduct long-term follow up of individuals who tested positive for COVID-19 compared to demographically matched individuals that did not.

Measure: Long-term follow up and recontact

Time: Up to 10 years

288 COlchicine in Moderate-severe Hospitalized Patients Before ARDS to Treat COVID-19 (the COMBAT-COVID-19 Pilot Study)

The most prevalent complication of COVID-19 infection is respiratory failure from severe acute respiratory syndrome (SARS), the leading cause of mortality. There is increasing indication that the decompensation in severe COVD-19 infection may be due to a cytokine storm syndrome. This hyperinflammatory syndrome results in a fulminant and fatal hypercytokinemia and multiorgan failure. Approximately 15% of patients with COVID-19 infection are hospitalized and 20-30% of these hospitalized patients require ICU care and/or mechanical ventilation. Overall mortality in hospitalized patients is approximately 20-25%. There is significant interest in therapies that can be given upstream to reduce the rate of mechanical ventilation and thus mortality. We hypothesize that treatment with colchicine in COVID-19 moderate-severe patients may decrease the risk of progression into ARDS requiring increased oxygen requirements, mechanical ventilation, and mortality.

NCT04363437 Coronavirus Infection Drug: Colchicine Drug: Usual Care

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Percentage of Patients requiring supplemental oxygen beyond 8L nasal cannula

Time: through study completion, estimated 2 months

Secondary Outcomes

Measure: Percentage of patients who will require mechanical ventillation

Time: through study completion, estimated 2 months

Measure: Hospital length of stay

Time: through study completion, estimated 2 months

Measure: Mortality

Time: through study completion, estimated 2 months

Measure: Maximum CRP

Time: through study completion, estimated 2 months

Measure: Maximum troponin elevation

Time: through study completion, estimated 2 months

289 Hydroxychloroquine as Primary Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP)

This a double-blind, randomized, placebo-controlled clinical trial to determine if primary prophylaxis with hydroxychloroquine in healthcare workers reduces symptomatic COVID-19 infection. Healthcare workers will be randomized at a 1:1 allocation between intervention and placebo arms and followed for 12 weeks. This study will enroll up to 1,700 participates in Lafayette, Louisiana. The primary outcome will number of symptomatic COVID-19 infections. Secondary endpoints included number of days healthcare workers are absent from work and rate of severe infection.

NCT04363450 COVID-19 Corona Virus Infection Wuhan Coronavirus Prophylaxis Healthcare Worker Sars-CoV2 Hydroxychloroquine Drug: Hydroxychloroquine Drug: Placebo

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of participants who develop symptoms of COVID-19 in the setting of a positive COVID-19 assay

Measure: Incidence of symptomatic COVID-19 infection in healthcare workers

Time: 12 weeks

Secondary Outcomes

Description: Number of days healthcare workers are absent from work due to symptomatic COVID-19 infection

Measure: Absenteeism from work due to COVID-19

Time: 12 weeks

Description: Rate of severe COVID-19 infection in healthcare works (hypoxia in setting of chest imaging >50% lung involvement, respiratory failure, end organ damage or shock)

Measure: Severity of COVID-19 infection

Time: 12 weeks

290 Serology COVID-19 From the Cornwall Hospital Union

Coronavirus (COVID-19) is a pandemic-like disease caused by a new coronavirus called Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV-2) isolated in China in 2019. Clinical manifestations vary widely from one individual to another, from asymptomatic carrier to a febrile cough that can rapidly lead to acute respiratory distress syndrome. Since the beginning of the COVID-19 epidemic, screening by chest X-ray (RT) and polymerase chain reaction (PCR) SARS-CoV-2 conducted by the Cornwall Hospital Union laboratory has shown that among symptomatic patients and hospital staff suspected of being COVID-19, only 7.8% were attributable to COVID-19. Two nosocomial clusters were also identified, in the emergency department (10 carers) and in the cardiology department (6 carers and one patient). However, direct diagnosis by RT-PCR has sensitivity limits and can lead to false negative results when the subject is indeed suffering from COVID-19. This lack of sensitivity is inherent to the technique on the one hand, but also to the quality of the sample and the kinetics of the infection. Indeed, the virological window during which the virus is present in the respiratory mucous membranes sampled seems relatively narrow, hence a progressive negativation of the respiratory samples as the disease progresses. Moreover, clinical symptoms vary from one individual to another, and it is now recognized that some infected persons are asymptomatic but carry the virus. Thus, the use of a second diagnostic technique is a necessity, and serology could be a relevant diagnostic support. In the literature, several publications report the performance of COVID-19 serology in clusters of cases or cohorts of subjects. The serological techniques employed are variable (target epitopes in particular) and frequently homemade. Serology is mainly studied in comparison or association with RT-PCR in order to highlight the increased performance of COVID-19 diagnosis when the two techniques are combined. Correlation with chest CT imaging data is also encountered. Numerous serological tests are therefore being tested to determine retrospectively whether the individual has been exposed to the virus by looking for specific antibodies to the virus. The supreme health authority has drawn up specifications dated 16 April 2020, defining the methods for evaluating the performance of serological tests detecting antibodies directed against SARSCoV-2 in order to provide a framework for these practices. Several clinical studies are also underway, in particular to assess the kinetics of the appearance of the antibodies, whether these specific antibodies would be protective and whether their appearance would coincide with a cessation of contagiousness. Thus, the main objective of this study is to evaluate the diagnostic performance of the COVID-19 immunoglobulin (IgG) Dia-Pro serological test, in view of its deployment at the Cornish Hospital Union Laboratory. Subsequently, given the low prevalence of COVID-19 in Brittany and the risk of a second epidemic wave when the confinement is lifted, the evaluation of the seroprevalence of the staff of the Cornish Hospital Union is necessary in order to assess the attack rate of COVID-19 within the establishment and particularly within departments where nosocomial clusters have been reported; and to prevent the impact of deconfinement. Indeed, knowledge of the proportion of immunized personnel and its distribution according to services will make it possible to establish internal recommendations and to effectively manage personal protective equipment inventories, in conjunction with the deconfinement strategy that will be implemented by the government. The goal is to protect hospital staff from overexposure to the virus;

NCT04363593 Corona Virus Infection Biological: Serological test Biological: Serum test

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The performance of the COVID-19 IgG Dia-Pro serological test is evaluated in terms of sensitivity/specificity.

Measure: Serological test evaluation

Time: 1 day

Secondary Outcomes

Description: Population seroprevalence among hospital staff (caregivers and non-caregivers) in Quimper Hospital is assessed

Measure: Population seroprevalence

Time: 1 month

291 PROTECT: A Randomized Study With Hydroxychloroquine Versus Observational Support for Prevention or Early Phase Treatment of Coronavirus Disease (COVID-19)

This is a Italian, superiority, open label cluster-randomised, interventional clinical trial aimed at assessing whether the treatment with Hydroxychloroquine can reduce the percentage of symptomatic subjects compared to observation only in household members/contacts of COVID-19 patients (Group 1) and if the treatment with Hydroxychloroquine could be introduced in early phase COVID-19 population (Group 2). The participants will be randomised to receive either: Arm A) hydroxychloroquine vs Arm B) Observation (2:1 randomisation).

NCT04363827 COVID19 Hydroxychloroquine Prophylaxis Treatment SARS-CoV-2 Drug: Hydroxychloroquine

MeSH:Coronavirus Infections

Primary Outcomes

Description: Group 1:The primary endpoint/outcome measure is the proportion of subjects of Group 1 who become symptomatic and/or swab positive in each arm within 1 month from randomization.

Measure: the proportion of subjects of Group 1 who become symptomatic and/or swab positive in each arm within 1 month from randomization.

Time: within 1 month from randomization

Description: Group 2: The primary endpoint/outcome measure is the proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization.

Measure: the proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization.

Time: within 14 days from randomization

Secondary Outcomes

Description: The proportion of subjects with positive swabs in randomized population of SARS-CoV-2-exposed subjects ( Group 1) within 1 month from randomization in both arms

Measure: The proportion of subjects with positive swabs in Group 1 within 1 month from randomization in both arms

Time: within 1 month from randomization

Description: The proportion of subjects of Group 1 who become symptomatic in each arm within 1 month from randomization, in subgroup population identified by stratification factors, class of age and gender.

Measure: The proportion of subjects of Group 1 who become symptomatic in each arm within 1 month from randomization

Time: within 1 month from randomization

Description: The proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization, in subgroup population identified by stratification factors, class of age and gender.

Measure: The proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization.

Time: within 14 days from randomization

Description: The proportion of subjects of Group 2 who become swab negative in each arm within 1 month from randomization in overall population and in subgroup population identified by stratification factors, class of age and gender.

Measure: The proportion of subjects of Group 2 who become swab negative in each arm within 1 month from randomization in overall population and in subgroup population

Time: within 1 month from randomization

Description: Absolute and relative frequencies of Serious Adverse Events (CTCAE version 5.0) in both arms for the Group 1 and Group 2.

Measure: Absolute and relative frequencies of Serious Adverse Events

Time: up to 10 months

Description: Variation in Quality of Life scores EQ-5D-5L (EQ-5D descriptive system with 5 severity levels from better to worse, and the EQ visual analogue scale (EQ VAS, scale from 100 to 0, high is better) in different time points (weekly) respect to baseline values in both Group 1 and Group 2 populations.

Measure: Variation in Quality of Life scores in different time points

Time: up to 10 months

292 Convalescent Plasma to Limit Coronavirus Associated Complications: a Randomized Blinded Phase 2 Study Comparing the Efficacy and Safety of Anti-SARS-CoV2 Plasma to Placebo in COVID-19 Hospitalized Patients

This is a randomized, blinded phase 2 trial that will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms requiring oxygen supplementation.

NCT04364737 COVID-19 Coronavirus Coronavirus Infection Biological: Convalescent Plasma Other: Saline solution

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Uninfected 0 Uninfected; no viral RNA detected Ambulatory 1 Asymptomatic; viral RNA detected 2 Symptomatic; Independent 3 Symptomatic; assistance needed Hospitalized: Mild disease 4 Hospitalized; no oxygen therapy 5 Hospitalized; oxygen by mask or nasal prongs Hospitalized: Severe disease 6 Hospitalized; oxygen by NIV or High flow 7 Intubation & Mechanical ventilation; pO2/FIO2 >/= 150 or SpO2/FIO2 >/=200 8 Mechanical ventilation pO2/FIO2 < 150 (SpO2/FIO2 <200) or vasopressors 9 Mechanical ventilation pO2/FIO2 < 150 and vasopressors, dialysis or ECMO Death 10 Dead

Measure: Score on the WHO 11-point ordinal scale for clinical improvement at 14 days

Time: 14 days post randomization

Secondary Outcomes

Measure: Score on the WHO 11-point ordinal scale for clinical improvement at 28 days

Time: 28 days post randomization

Other Outcomes

Description: Anti-SARS-CoV-2 titers (IgM, IgG, IgA)

Measure: Comparison in Anti-SARS-CoV-2 antibody titers

Time: 0, 1, 7, 14, 28, 90 days post randomization

Description: SARS-CoV-2 PCR in nasopharyngeal swabs

Measure: Proportion positive in SARS-CoV-2 RNA

Time: 0, 7, 14, 28 days post randomization

Description: Rate of mortality

Measure: Mortality

Time: 7, 14, 28 days post randomization

Description: Percentage of patients requiring Intensive Care Unit admission

Measure: Rates of Intensive Care Unit admission

Time: 7, 14, 28 days post randomization

Description: Lymphocyte counts

Measure: Changes from baseline in lymphocyte

Time: 0, 1, 3, 7, 14 days post randomization

Description: Neutrophil counts

Measure: Changes from baseline in neutrophils

Time: 0, 1, 3, 7, 14 days post randomization

Description: D-dimer level

Measure: Changes from baseline in D-dimer

Time: 0, 1, 3, 7, 14 days post randomization

Description: Fibrinogen level

Measure: Changes from baseline in fibrinogen

Time: 0, 1, 3, 7, 14 days post randomization

Description: T cell subsets

Measure: Changes from baseline in T lymphocyte subsets

Time: 0, 7, 28 days post randomization

Description: B cell subsets

Measure: Changes from baseline in B lymphocyte subsets

Time: 0, 1, 3, 7, 14 days post randomization

293 Suspension of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors and Adverse Outcomes in Hospitalized Patients With Coronavirus Infection (COVID-19). A Randomized Trial

Suspension of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors and Adverse Outcomes in Hospitalized Patients With Coronavirus Infection.

NCT04364893 Corona Virus Infection COVID-19 Other: Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors

MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary outcome of the study will be days alive and outside the hospital (DAOH) at 30 days. This endpoint will be calculated for each included patient and the calculation will be from the date of randomization to the 30-day post-randomization. The DAOH endpoint represents the follow-up time (30 days) subtracted from the hospitalization days and/or the days between death and the end of follow-up.

Measure: Median days alive and out of the hospital

Time: 30 days

Secondary Outcomes

Description: Cardiovascular outcomes such as progression of COVID-19, mortality (general and cardiovascular), acute myocardial infarction, stroke / TIA, new heart failure or worsening of pre-existing HF, myocarditis, pericarditis, arrhythmias requiring treatment, phenomena thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure. All events will be reported according to CTCAE 4.0

Measure: Number of participants with adverse cardiovascular outcomes and new worsening heart failure

Time: 30 days

Description: Evaluate levels of biomarkers [troponin, type B natriuretic peptide (BNP), N-terminal natriuretic peptide type B (NT-ProBNP), D-dimer, total lymphocytes , CD4, CD8, macrophages, cytokines, in addition to biomarkers detected by proteomics and metabolomics].

Measure: Cardiovascular biomarkers related to COVID-19

Time: up to 30 days

294 A Phase I/II Study of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK-001) for the Treatment of Adults With COVID-19

This study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, an immunotherapy containing Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded, in hospitalized patients with moderate COVID-19 disease.

NCT04365101 Coronavirus Coronavirus Infection Severe Acute Respiratory Syndrome Coronavirus 2 Pneumonia Pneumonia, Viral Lung Diseases Respiratory Tract Disease Respiratory Tract Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Virus Disease Immunologic Disease ARDS Immunologic Factors Physiological Effects of Drugs Antiviral Agents Anti-infective Agents Analgesics Antimetabolites, Antineoplastic Biological: CYNK-001

MeSH:Infection Communicable Dis Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome RNA Virus Infections Pneumonia, Viral Coronaviridae Infections Nidovirales Infections Pneumonia Lung Diseases Virus Diseases Respiratory Tract Diseases Immune System Diseases

HPO:Abnormal lung morphology Pneumonia Respiratory tract infection

Primary Outcomes

Description: Number and severity of adverse events

Measure: Phase 1: Frequency and Severity of Adverse Events (AE)

Time: Up to 12 months

Description: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR

Measure: Phase 1: Rate of clearance of SARS-CoV-2

Time: Up to 12 months

Description: Proportion of subjects who improved clinical symptoms related to lower respiratory tract infection, as measured by National Early Warning Score 2 (NEWS2) score.

Measure: Phase 1: Rate of clinical improvement

Time: Up to 12 months

Description: Time from the date of randomization to the clearance of SARS-CoV-2 by rRT-PCR in nasal and/or lower respiratory tract samples. Negative results will need to be confirmed by a second negative result in the same sample type at least 24 hours after the first negative result.

Measure: Phase 2: Time to Clearance of SARS-CoV-2

Time: Up to 28 days

Description: Time from the date of randomization to the first date of improved clinical symptoms related to lower respiratory tract infection. Improvement as measured by National Early Warning Score 2 (NEWS2) Score.

Measure: Phase 2: Time to Clinical Improvement by NEWS2 Score

Time: Up to 28 days

Secondary Outcomes

Description: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR

Measure: Rate of Clearance of SARS-CoV-2

Time: Up to 12 months

Description: Number and severity of adverse events

Measure: Phase 2: Frequency and Severity of Adverse Events (AE)

Time: up to 12 months

Description: Time to medical discharge as an assessment of overall clinical benefit

Measure: Overall Clinical Benefit by time to medical discharge

Time: up to 12 months

Description: Hospital utilization will be measured as an assessment of overall clinical benefit

Measure: Overall Clinical Benefit by hospital utilization

Time: up to 12 months

Description: Mortality rate will be measured as an assessment of overall clinical benefit

Measure: Overall Clinical Benefit by measuring mortality rate

Time: up to 12 months

Description: Assess the impact of CYNK-001 on changes in sequential organ failure assessment (SOFA) score.

Measure: Impact of CYNK-001 on sequential organ failure assessment (SOFA) score

Time: Up to 28 days

Description: Time from randomization to the date of disappearance of virus from lower respiratory tract infection (LRTI) specimen where it has previously been found (induced sputum, endotracheal aspirate).

Measure: Time to Pulmonary Clearance

Time: Up to 28 days

Description: For ventilatory support subjects, the days with supplemental oxygen-free.

Measure: Supplemental oxygen-free days

Time: Up to 28 days

Description: Proportion of subjects who need invasive or non-invasive ventilation

Measure: Proportion of subjects requiring ventilation

Time: Up to 28 days

295 Protective Effect of Aspirin on COVID-19 Patients

COVID-19 has a high infection rate and mortality, and serious complications such as heart injury cannot be ignored. Cardiac dysfunction occurred in COVID-19 patients, but the law and mechanism of cardiac dysfunction remains unclear. The occurrence of progressive inflammatory factor storm and coagulation dysfunction in severe and fatal cases of NCP points out a new direction for reducing the incidence of severe and critically ill patients, shortening the length of duration in severe and critically ill patients and reducing the incidence of complications of cardiovascular diseases. Aspirin has the triple effects of inhibiting virus replication, anticoagulant and anti-inflammatory, but it has not received attention in the treatment and prevention of NCP. Although Aspirin is not commonly used in the guidelines for the treatment of NCP, it was widely used in the treatment and prevention of a variety of human diseases after its first synthesis in 1898. Subsequently, aspirin has been confirmed to have antiviral effect on multiple levels. Moreover, one study has confirmed that aspirin can inhibit virus replication by inhibiting prostaglandin E2 (PGE2) in macrophages and upregulation of type I interferon production. Subsequently, pharmacological studies have found that aspirin as an anti-inflammatory and analgesic drug by inhibiting cox-oxidase (COX). Under certain conditions, the platelet is the main contributor of innate immune response, studies have found that in the lung injury model in dynamic neutrophil and platelet aggregation. In summary, the early use of aspirin in covid-19 patients, which has the effects of inhibiting virus replication, anti-platelet aggregation, anti-inflammatory and anti-lung injury, is expected to reduce the incidence of severe and critical patients, shorten the length of hospital duration and reduce the incidence of cardiovascular complications.

NCT04365309 Novel Coronavirus Pneumonia Aspirin Treatment Drug: Aspirin 100mg

MeSH:Coronavirus Infections Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: TTCR is defined as the study treatment (oral aspirin enteric-coated tablet) began to fever, breathing rate, blood oxygen saturation recovery, and cough relieving for at least 72 hours.

Measure: clinical recovery time (TTCR)

Time: not more than 14 days

Description: Time of SARS-CoV2 in upper respiratory tract specimens overcasting detected by RT-PCR.

Measure: the time of SARS-CoV2 overcasting

Time: not more than 37 days

296 Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19

Ideal new treatments for Novel Coronavirus-19 (COVID-19) would help halt the progression disease in patients with mild disease prior to the need for artificial respiration (ventilators), and also provide a rescue treatment for patients with severe disease, while also being affordable and available in quantities sufficient to treat large numbers of infected people. Low doses of Naltrexone, a drug approved for treating alcoholism and opiate addiction, as well as Ketamine, a drug approved as an anesthetic, may be able to interrupt the inflammation that causes the worst COVID-19 symptoms and prove an effective new treatment. This study will investigate their effectiveness in a randomized, blinded trial versus standard treatment plus placebo.

NCT04365985 COVID-19 Acute Respiratory Distress Syndrome Severe Acute Respiratory Syndrome (SARS) Coronavirus Infections Drug: Naltrexone Drug: Ketamine Other: Placebo

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Description: Count of participants initially presenting with mild/moderate disease who progress to requiring advanced oxygenation (high flow nasal canula, non-rebreather, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or intubation)

Measure: Progression of oxygenation needs

Time: up to 1 month

Secondary Outcomes

Description: Count of participants who develop or experience worsened renal failure as defined by RIFLE criteria, a 5-point scale where the categories are labeled: Risk-Injury-Failure-Loss-End stage renal disease, with Risk being the least severe and End stage renal disease being the most severe. The criteria for determination of stage are factors of serum creatinine and urine output. Numbers of participants worsening one or more RIFLE stages will be reported.

Measure: Renal failure

Time: up to 1 month

Description: Count of participants who develop or experience worsened liver failure as defined by serum transaminases five times normal limits

Measure: Liver failure

Time: up to 1 month

Description: Count of participants who develop cytokine storm as measured by elevated markers of inflammation (elevated D-dimer, hypofibrinogenemia, hyperferritinemia), evidence of acute respiratory distress syndrome (ARDS) measured by imaging findings and mechanical ventilator requirements, and/or continuous fever (≥ 38.1 ° Celsius unremitting)

Measure: Cytokine Storm

Time: up to 1 month

Description: Count of participants who die from COVID-19

Measure: Mortality

Time: up to 1 month post hospital discharge

Description: Length of hospital stay in days

Measure: Length of hospital stay

Time: up to 1 month

Description: Count of patients admitted to the ICU at any time during index hospitalization

Measure: Intensive Care Unit (ICU) admission

Time: up to 1 month

Description: Length of ICU stay in days

Measure: Intensive Care Unit (ICU) duration

Time: up to 1 month

Description: Count of participants requiring intubation

Measure: Intubation

Time: up to 1 month

Description: Length of intubation, measured in days

Measure: Intubation duration

Time: up to 1 month

Description: Time measured in days from hospital admission to determination patient is stable for discharge

Measure: Time until recovery

Time: up to 1 month

297 Oxygen-Ozone as Adjuvant Treatment in Early Control of Disease Progression in Patients With COVID-19 Associated With Modulation of the Gut Microbial Flora

Italy was the first European country affected by a severe outbreak of the Severe Acute Respiratory Syndrome - CoronaVirus-2 (SARS-CoV-2) epidemic emerged from Wuhan region (China), with a high morbidity and mortality associated with the disease. In light of its pandemic spread and the very limited therapeutic options, COronaVIrus Disease 19 (COVID-19) is considered an unprecedented global health challenge. Therefore, the evaluation of new resources, designed in the first instance for other pathologies but potentially active against COVID-19, represents a priority in clinical research. This is an interventional, non-pharmacological, open, randomized, prospective, non-profit study on the adjuvant use of oxygen ozone therapy plus probiotic supplementation in the early control of disease progression in patients with COVID-19. Contextually, all patients are treated with the current standard of care on the basis of the interim guidelines of the Italian Society of Infectious and Tropical Diseases. The main purpose of the study is to evaluate the effectiveness of an ozone therapy-based intervention (accompanied by supplementation with probiotics) in containing the progression of COVID-19 and in preventing the need for hospitalization in intensive care units.

NCT04366089 COVID SARS-CoV 2 Pneumonia, Viral Coronavirus Infection Other: Oxygen-ozone therapy, probiotic supplementation and Standard of care Dietary Supplement: SivoMixx (200 billion) Drug: Azithromycin Drug: hydroxychloroquine

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: Comparison between the two groups

Measure: Delta in the number of patients requiring orotracheal intubation despite treatment

Time: 21 days

Secondary Outcomes

Description: Comparison between the two groups

Measure: Delta of crude mortality

Time: 21 days

Description: Comparison between the two groups

Measure: Delta of length of stay for patients in hospital

Time: 90 days

Description: Comparison between the two groups

Measure: delta in the value of interleukin (IL)-1

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of IL-6

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of IL-10

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of Tumor Necrosis Factor (TNF)-alpha

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of cluster of differentiation (CD)4+ CD38/ Human Leukocyte Antigen-DR isotype (HLA-DR)

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of CD8+ CD38/ HLA-DR

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of fecal calprotectin

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of lipopolysaccharide (LPS)

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of zonulin

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of alpha1-antitrypsin

Time: 21 days

298 The RESCUE 1-19 Trial: Radiation Eliminates Storming Cytokines and Unchecked Edema as a 1-Day Treatment for COVID-19

This phase I/II trial studies low-dose radiation therapy as a focal anti-inflammatory treatment for patients with pneumonia or SARS associated with COVID-19 infection.

NCT04366791 Pneumonia Coronavirus Infection in 2019 (COVID-19) Severe Acute Respiratory Syndrome (SARS) Pneumonia Radiation: Low Dose Radiation Therapy

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: The rate will be reported, along with a two-sided 95% exact binomial confidence interval, using the Clopper-Pearson method. The observed extubation rate will be compared to the null rate of 20% using a two-sided binomial test. Statistical significance is assessed at the 0.05 level.

Measure: Rate of extubation (for intubated patients)