Correlated Drug Terms (384)

---

	Name (Synonyms)	Correlation
drug1284	Hydroxychloroquine Wiki	0.27
drug1087	Favipiravir Wiki	0.25
drug2122	Placebo Wiki	0.20
drug2161	Placebo oral tablet Wiki	0.16
drug3150	Zinc Wiki	0.12
drug1285	Hydroxychloroquine (HCQ) Wiki	0.12
drug3085	Vitamin C Wiki	0.11
drug1210	HB-adMSCs Wiki	0.11
drug1386	Imatinib Wiki	0.11
drug1287	Hydroxychloroquine + Azithromycin Wiki	0.11
drug1607	Losartan Wiki	0.11
drug1095	Favipiravir Placebo Wiki	0.11
drug1313	Hydroxychloroquine Sulfate Tablets Wiki	0.11
drug2158	Placebo on a 0- and 28-day schedule Wiki	0.11
drug1714	Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki	0.11
drug2713	Standard of care treatment Wiki	0.11
drug1251	High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki	0.11
drug1617	Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki	0.11
drug966	Ebselen Wiki	0.11
drug1301	Hydroxychloroquine Sulfate Wiki	0.11
drug812	DAS181 Wiki	0.10
drug424	Biospecimen Collection Wiki	0.09
drug1211	HCQ Wiki	0.09
drug3039	VPM1002 Wiki	0.09
drug1434	Interferon Beta-1B Wiki	0.09
drug1389	Immunfluorescence Wiki	0.08
drug569	COVID-19 test, polymerase chain reaction for SARS-CoV-2 Wiki	0.08
drug1236	Hemanext One Wiki	0.08
drug1112	Fit test Wiki	0.08
drug1309	Hydroxychloroquine Sulfate 600 mg once a day Wiki	0.08
drug2001	Others(No intervention) Wiki	0.08
drug2664	Specimen Collection Wiki	0.08
drug1063	EyeQue Insight Wiki	0.08
drug1244	High Dose of KBP-COVID-19 Wiki	0.08
drug3446	remdesivir Wiki	0.08
drug1338	Hyperbaric oxygen therapy Wiki	0.08
drug1314	Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets Wiki	0.08
drug1039	Exercise capacity Wiki	0.08
drug2469	Routine standard of care Wiki	0.08
drug1082	Facial mask Wiki	0.08
drug1624	Low nitrite/NDMA meals Wiki	0.08
drug3376	non-contact magnetically-controlled capsule endoscopy Wiki	0.08
drug2171	Placebo- 1.00 mg/kg Wiki	0.08
drug1332	Hydroxychloroquine/Chloroquine Wiki	0.08
drug1040	Exercise physiology Wiki	0.08
drug1107	FilmArray PCR on respiratory samples Wiki	0.08
drug1817	NIVOLUMAB Wiki	0.08
drug2129	Placebo 0.20 mg + 2.00 mg/kg Wiki	0.08
drug1880	Nitric Oxide-Releasing Drug Wiki	0.08
drug887	Dietary Intervention Wiki	0.08
drug1165	Gam-COVID-Vac Wiki	0.08
drug3101	WHO recommendations (waiting condition) Wiki	0.08
drug479	Bromhexine Hydrochloride Wiki	0.08
drug1088	Favipiravir (3200 mg + 1200 mg) Wiki	0.08
drug1365	IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki	0.08
drug1277	Human milk donors Wiki	0.08
drug2780	Surveys Wiki	0.08
drug1569	Liberase Enzyme (Roche) Wiki	0.08
drug1038	Exercise brochure Wiki	0.08
drug814	DAS181 OL Wiki	0.08
drug1257	High-flow nasal cannula Wiki	0.08
drug2157	Placebo on a 0- and 14-day schedule Wiki	0.08
drug3340	metenkefalin + tridecactide Wiki	0.08
drug1384	Imaging by thoracic scanner Wiki	0.08
drug3001	Umbilical Cord Lining Stem Cells (ULSC) Wiki	0.08
drug1547	Laboratory tests Wiki	0.08
drug1984	Only Standard Treatment Wiki	0.08
drug1250	High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki	0.08
drug3046	Vancomycin Wiki	0.08
drug1324	Hydroxychloroquine sulfate &Azithromycin Wiki	0.08
drug3365	nebulization Wiki	0.08
drug3405	phone call Wiki	0.08
drug1085	Famotidine 20 MG Wiki	0.08
drug1275	Human biological samples Wiki	0.08
drug33	2: Usual practice + SYMBICORT RAPIHALER Wiki	0.08
drug1261	Home exercise Wiki	0.08
drug303	Avdoralimab Wiki	0.08
drug1837	NasoVAX Wiki	0.08
drug1154	GO2 PEEP MOUTHPIECE Wiki	0.08
drug1265	Home-use Test and Follow-up Questionnaire Wiki	0.08
drug2223	Presatovir Wiki	0.08
drug1072	FFP2 Wiki	0.08
drug3238	conventional management of patients Wiki	0.08
drug2448	Rintatolimod Wiki	0.08
drug1811	NA-831and Dexamethasone Wiki	0.08
drug1274	Human Coach first, then Virtual Assistant Wiki	0.08
drug1787	Mucodentol Wiki	0.08
drug1393	Immunoglubulins Wiki	0.08
drug2852	Telemedicine follow-up visit Wiki	0.08
drug457	Bolus vitamin D3 Wiki	0.08
drug3500	tracheostomy Wiki	0.08
drug122	AZD8154 Placebo Monodose DPI presented in capsules Wiki	0.08
drug1400	In-person in clinic follow-up visit Wiki	0.08
drug1256	High-Titer COVID-19 Convalescent Plasma (HT-CCP) Wiki	0.08
drug929	Drug: NA-831 - 0.10 mg/kg Wiki	0.08
drug1137	Fourth Trimester Mobile Tool Wiki	0.08
drug1205	Guided online support program Wiki	0.08
drug813	DAS181 COVID-19 Wiki	0.08
drug1270	Hospitalized Patients for COVID-19 Infection Wiki	0.08
drug1430	Inspiratory training device Wiki	0.08
drug280	Atazanavir and Dexamethasone Wiki	0.08
drug1507	JNJ-53718678 Wiki	0.08
drug1043	Experimental Group Wiki	0.08
drug1229	Health-related quality of life Wiki	0.08
drug1375	Icosapent ethyl (IPE) Wiki	0.08
drug1044	Experimental drug Wiki	0.08
drug2720	Standard therapy Wiki	0.08
drug3091	Vitamins Wiki	0.08
drug3328	lung ultrasound (LUS) Wiki	0.08
drug2433	Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening Wiki	0.08
drug1494	Ivermectin 3Mg Tab Wiki	0.08
drug120	AZD7442 Wiki	0.08
drug1093	Favipiravir + Standard of Care Wiki	0.08
drug2550	Saliva Wiki	0.08
drug756	Convalescent Plasma 2 Units Wiki	0.08
drug631	Centricyte 1000 Wiki	0.08
drug448	Blood sample for whole genome sequencing Wiki	0.08
drug3289	hydroxychloroquine in combination with camostat mesylate Wiki	0.08
drug1320	Hydroxychloroquine in combination of Azithromycin Wiki	0.08
drug1294	Hydroxychloroquine - Daily dosing Wiki	0.08
drug1089	Favipiravir (3200 mg + 1200 mg) combined with Azithromycin Wiki	0.08
drug49	50 mg/mL Virazole Wiki	0.08
drug1155	GPs reports of potential patient safety incidents, non-COVID-19 related Wiki	0.08
drug1064	F-652 Wiki	0.08
drug254	ArtemiC Wiki	0.08
drug1394	Immunological profiling Wiki	0.08
drug648	Chest MRI Wiki	0.08
drug3377	non-interventional Wiki	0.08
drug2318	Questionnaire with precaution information Wiki	0.08
drug1378	IgG antibodies immunoassay Wiki	0.08
drug1259	Home Pulse Oximetry Monitoring Wiki	0.08
drug1356	INM005 Wiki	0.08
drug2384	Recombinant Interferon Alfa-2b Wiki	0.08
drug3236	convalescent plasma application to SARS-CoV-2 infected patients Wiki	0.08
drug2162	Placebo plus standard preventive measures Wiki	0.08
drug1612	Low Dose of KBP-COVID-19 Wiki	0.08
drug1310	Hydroxychloroquine Sulfate 600 mg twice a day Wiki	0.08
drug3324	lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate Wiki	0.08
drug1119	Flow controlled ventilation (Evone-ventilator) Wiki	0.08
drug3028	Use of virus (Covid-19) genome sequence report to inform infection prevention control procedures Wiki	0.08
drug1253	High nitrite/NDMA meals Wiki	0.08
drug912	Doctor Spot Wiki	0.08
drug925	Drug: GS-5734 - 1.00 mg/kg Wiki	0.08
drug1166	Gam-COVID-Vac Lyo Wiki	0.08
drug932	Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg) Wiki	0.08
drug2794	T3 solution for injection Wiki	0.08
drug22	1: Usual practice Wiki	0.08
drug1170	Gargle/Mouthwash Wiki	0.08
drug3093	VivaDiag™ COVID-19 lgM/IgG Rapid Test Wiki	0.08
drug658	Chloroquine analog (GNS651) Wiki	0.08
drug121	AZD8154 Monodose DPI presented in capsules Wiki	0.08
drug983	Electronic Health Record Review Wiki	0.08
drug1363	IP-10 in CDS protocol Wiki	0.08
drug2126	Placebo (carrier control) Wiki	0.08
drug2170	Placebo- 0.20 mg/kg Wiki	0.08
drug755	Convalescent Plasma 1 Unit Wiki	0.08
drug3214	bronchoscopy examination Wiki	0.08
drug1499	Ivermectin Pill Wiki	0.08
drug3246	decisions of limitations and stop processing Wiki	0.08
drug2128	Placebo 0.10 mg + 1.00 mg/kg Wiki	0.08
drug880	Diagnostic Laboratory Biomarker Analysis Wiki	0.08
drug1264	Home-based exercise Wiki	0.08
drug2454	Ritonavir Wiki	0.08
drug1395	Immunosuppressive Wiki	0.08
drug1302	Hydroxychloroquine Sulfate (HCQ) Wiki	0.08
drug1126	Fluzone High Dose Wiki	0.08
drug2358	Rabeprazole Wiki	0.08
drug830	Daily placebo Wiki	0.08
drug2904	There is no intervention in this study Wiki	0.08
drug901	Dipyridamole 100 Milligram(mg) Wiki	0.08
drug1833	Nasal Dexamethasone Wiki	0.08
drug1594	Lopinavir and Ritonavir Tablets Wiki	0.08
drug1201	Group1 Wiki	0.08
drug1316	Hydroxychloroquine and azithromycin treatment Wiki	0.08
drug1297	Hydroxychloroquine Only Product in Oral Dose Form Wiki	0.08
drug3231	congenital malformation Wiki	0.08
drug1103	Fidaxomicin Wiki	0.08
drug1220	HOPE intervention Wiki	0.08
drug1491	Ivermectin + Doxycycline Wiki	0.08
drug2234	Probiorinse Wiki	0.08
drug1823	NO-Immunosuppressive Wiki	0.08
drug2367	Ranitidine Wiki	0.08
drug2717	Standard screening strategy Wiki	0.08
drug1162	GX-19 Wiki	0.08
drug1124	Fluvirin Wiki	0.08
drug1135	Formulation without Active Drug Wiki	0.08
drug2172	Placebo- 2.00 mg/kg Wiki	0.08
drug3	- Synthetic anti-malarial drugs Wiki	0.08
drug2224	Presatovir placebo Wiki	0.08
drug1405	Indomethacin Wiki	0.08
drug3322	lopinavir/ritonavir Wiki	0.08
drug3071	Virtual Assistant first, then Human Coach Wiki	0.08
drug1651	MFS Wiki	0.08
drug1367	IVERMECTIN (IVER P®) arm will receive IVM 600 µg / kg once daily plus standard care. CONTROL arm will receive standard care. Wiki	0.08
drug1056	Extra blood sample Wiki	0.08
drug1212	HCQ & AZ Wiki	0.08
drug14	100 mg/mL Virazole Wiki	0.08
drug1773	Monalizumab Wiki	0.08
drug3167	additional blood tubes Wiki	0.08
drug3212	blood test for SARS-COV2 serology Wiki	0.08
drug930	Drug: NA-831 - 0.20 mg/kg Wiki	0.08
drug3517	washed microbiota transplantation Wiki	0.08
drug3502	trimethoprim/sulfamethoxazole Wiki	0.08
drug934	Duodenal biopsy Wiki	0.08
drug2047	Pacebo: Calcium citrate Wiki	0.08
drug1299	Hydroxychloroquine Pre-Exposure Prophylaxis Wiki	0.08
drug1376	Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus Wiki	0.08
drug456	Bolus placebo Wiki	0.08
drug2097	Personal protective equipment Wiki	0.08
drug1379	IgG test Wiki	0.08
drug361	BNT162c2 Wiki	0.08
drug1292	Hydroxychloroquine , Sofosbuvir, daclatasvir Wiki	0.08
drug1209	HB-adMSC Wiki	0.08
drug1713	Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki	0.08
drug1308	Hydroxychloroquine Sulfate 400 mg twice a day Wiki	0.08
drug1319	Hydroxychloroquine combined with Azithromycin Wiki	0.08
drug2099	Personalized Anchoring Strategy Wiki	0.08
drug620	Carrimycin Wiki	0.08
drug340	BI 1569912 Wiki	0.08
drug2137	Placebo Group Wiki	0.08
drug1932	Nutrition Wiki	0.08
drug1096	Favipiravir and Hydroxychloroquine Wiki	0.08
drug2926	To assess for development of IgG antibodies against SARS-CoV2 Wiki	0.08
drug2892	The standard of care Wiki	0.08
drug2971	Treatment with Dexmedetomidine Wiki	0.08
drug1121	Flucelvax Wiki	0.08
drug1111	Fisetin Wiki	0.08
drug1303	Hydroxychloroquine Sulfate + Azithromycin Wiki	0.08
drug1271	Huaier Granule Wiki	0.08
drug716	Combined ART/hydroxychloroquine Wiki	0.08
drug1377	IgG Wiki	0.08
drug1903	Non-Anchoring Strategy Control Wiki	0.08
drug1090	Favipiravir (3200 mg + 1200 mg) combined with Hydroxychloroquine Wiki	0.08
drug1349	ID NOW vs. Accula Wiki	0.08
drug651	Chinese Herbal Medicine Wiki	0.08
drug928	Drug: NA-831 Wiki	0.08
drug1046	Expiratory training device Wiki	0.08
drug1114	Fixed Anchoring Strategy Wiki	0.08
drug1585	Lopinavir Wiki	0.08
drug358	BNT162a1 Wiki	0.08
drug565	COVID-19 positive via testing Wiki	0.08
drug1746	Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki	0.08
drug2771	Surgical mask Wiki	0.08
drug1150	GLS-1200 Wiki	0.08
drug1033	Examine the impact of COVID-19 during pregnancy Wiki	0.08
drug1345	IC14 Wiki	0.08
drug1424	Inhaled nitric oxide gas Wiki	0.08
drug1634	Lung Function tests Wiki	0.08
drug2884	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	0.08
drug2743	Sterile Normal Saline for Intravenous Use Wiki	0.08
drug1355	INC424 / Ruxolitinib Wiki	0.08
drug1366	IV Dexamethasone Wiki	0.08
drug1646	MEDI7219 Wiki	0.08
drug3345	mobile internet survey on self-test Wiki	0.08
drug1045	Experimental: Questionnaire without precaution information Wiki	0.08
drug2169	Placebo- 0.10 mg/kg Wiki	0.08
drug3469	standard concomitant therapy Wiki	0.08
drug1080	Face mask sampling Wiki	0.08
drug1321	Hydroxychloroquine plus Nitazoxanide Wiki	0.08
drug3087	Vitamin D 1000 IU Wiki	0.08
drug1322	Hydroxychloroquine plus standard preventive measures Wiki	0.08
drug916	Dornase Alfa Inhalation Solution Wiki	0.08
drug1551	Lactoferrin (Apolactoferrin) Wiki	0.08
drug1222	Halo Oral Spray Wiki	0.08
drug1810	NA-831 and Atazanavir Wiki	0.08
drug933	Drugs: NA-831 (0.20 mg/kg) plus GS-5734 (2.00 mg/kg) Wiki	0.08
drug3309	intubation Wiki	0.08
drug1599	Lopinavir/ Ritonavir Oral Tablet Wiki	0.08
drug1876	Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation Wiki	0.08
drug1924	Normobaric oxygen therapy Wiki	0.08
drug592	CYNK-001 Wiki	0.08
drug1272	Human Amniotic Fluid Wiki	0.08
drug731	Conestat alfa Wiki	0.08
drug533	COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support Wiki	0.08
drug1262	Home exercise program Wiki	0.08
drug1687	Matched Placebo Hydroxychloroquine Wiki	0.08
drug1600	Lopinavir/ Ritonavir Placebo Wiki	0.08
drug923	Doxycycline Hcl Wiki	0.08
drug670	Ciclesonide Inhalation Aerosol Wiki	0.08
drug2426	ResCure™ Wiki	0.08
drug3124	Whole Exome Sequencing Wiki	0.08
drug2686	Standard Plasma (FFP) Wiki	0.08
drug2156	Placebo of excipient(s) will be administered Wiki	0.08
drug2269	Psychological and Behaviour Change Support Wiki	0.08
drug2350	RT PCR SARS-CoV-2 Wiki	0.08
drug1420	Inhaled beclomethasone Wiki	0.08
drug1055	Extended sampling and procedures Wiki	0.08
drug3156	Zithromax Oral Product Wiki	0.08
drug1120	Flow cytometry Wiki	0.08
drug1091	Favipiravir (3600 mg + 1600 mg) Wiki	0.08
drug2747	Stool collection or fecal swab Wiki	0.08
drug1616	Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki	0.08
drug572	COVID-surgRES questionaire Wiki	0.08
drug1318	Hydroxychloroquine as post exposure prophylaxis Wiki	0.08
drug1084	Famotidine Wiki	0.08
drug829	Daily Vitamin D3 Wiki	0.08
drug1859	New screening strategy Wiki	0.08
drug1219	HOME-CoV rule implementation Wiki	0.08
drug926	Drug: GS-5734 - 2.00 mg/kg Wiki	0.08
drug1213	HCQ & AZ vs HCQ+SIR Wiki	0.08
drug2280	Pulmonary function test Wiki	0.08
drug674	Clarithromycin Wiki	0.08
drug1214	HCQ+AZT Wiki	0.08
drug1109	Filtration Test Wiki	0.08
drug2419	Remote controlled exercise Wiki	0.08
drug1598	Lopinavir/ Ritonavir Wiki	0.08
drug1677	Mannitol Wiki	0.08
drug3183	artus Influenza A/B RT-PCR Test Wiki	0.08
drug3316	labs Wiki	0.08
drug1625	Low or upper respiratory tract sample Wiki	0.08
drug2945	Tradipitant Wiki	0.08
drug3047	Vancomycin with Taper/Pulse Wiki	0.08
drug1908	Non-contact MCE system Wiki	0.08
drug1073	FLOW intervention Wiki	0.08
drug348	BIOMARKERS IN THE LONG TERM IMPACT OF CORONAVIRUS INFECTION IN THE CARDIORRESPIRATORY SYSTEM Wiki	0.08
drug1223	Halo Placebo Wiki	0.08
drug123	AZD8154 nebuliser Wiki	0.08
drug1019	Ergoferon Wiki	0.08
drug2176	Placebos Wiki	0.08
drug1586	Lopinavir / Ritonavir Wiki	0.07
drug3209	blood sampling Wiki	0.07
drug313	Azithromycin Wiki	0.07
drug192	Anakinra Wiki	0.06
drug2698	Standard of Care Wiki	0.06
drug2586	Selinexor Wiki	0.06
drug837	Data Collection Wiki	0.06
drug359	BNT162b1 Wiki	0.06
drug1130	Follow up Wiki	0.06
drug3193	basic treatment Wiki	0.06
drug2708	Standard of care (SOC) Wiki	0.06
drug360	BNT162b2 Wiki	0.06
drug1048	Exposure Wiki	0.06
drug2468	Routine care for COVID-19 patients Wiki	0.06
drug3086	Vitamin D Wiki	0.06
drug249	Arbidol Wiki	0.06
drug564	COVID-19 patients Wiki	0.06
drug1824	NORS (Nitric Oxide Releasing Solution) Wiki	0.06
drug1305	Hydroxychloroquine Sulfate 200 MG Wiki	0.06
drug3208	blood samples Wiki	0.06
drug26	200 mg EIDD-2801 Wiki	0.06
drug1736	Mesenchymal stromal cells Wiki	0.06
drug551	COVID-19 Therapeutic Vaccine - Nucleocapsid-GM-CSF Protein Lactated Ringer's Injection Wiki	0.06
drug1035	Exercise Wiki	0.06
drug2360	Radiation therapy Wiki	0.06
drug1295	Hydroxychloroquine - Weekly Dosing Wiki	0.06
drug1401	Inactivated SARS-CoV-2 Vaccine (Vero cell) Wiki	0.06
drug1374	Icosapent ethyl Wiki	0.06
drug437	Blood draw Wiki	0.06
drug657	Chloroquine Sulfate Wiki	0.06
drug1151	GLS-5300 Wiki	0.06
drug2547	Saline solution Wiki	0.06
drug124	Abatacept Wiki	0.06
drug443	Blood sample Wiki	0.05
drug1605	Lopinavir/ritonavir Wiki	0.05
drug2311	Questionnaire Wiki	0.05
drug336	BCG vaccine Wiki	0.05
drug2862	Telmisartan Wiki	0.05
drug1306	Hydroxychloroquine Sulfate 200 MG [Plaquenil] Wiki	0.05
drug1883	Nivolumab Wiki	0.05
drug2928	Tocilizumab Wiki	0.04
drug922	Doxycycline Wiki	0.04
drug131	Acalabrutinib Wiki	0.04
drug1875	Nitric Oxide Wiki	0.04
drug3287	hydroxychloroquine Wiki	0.04
drug2202	Povidone-Iodine Wiki	0.04
drug2850	Telemedicine Wiki	0.04
drug1841	Nasopharyngeal swab Wiki	0.04
drug2860	Telerehabilitation Wiki	0.04
drug1433	Interferon Beta-1A Wiki	0.04
drug1887	No intervention Wiki	0.04
drug603	Camostat Mesilate Wiki	0.04
drug1489	Ivermectin Wiki	0.04
drug535	COVID-19 Convalescent Plasma Wiki	0.04
drug752	Convalescent Plasma Wiki	0.03
drug3088	Vitamin D3 Wiki	0.03
drug870	Dexamethasone Wiki	0.03
drug3206	blood sample Wiki	0.03
drug675	Clazakizumab Wiki	0.03
drug2540	Saline Wiki	0.03
drug2312	Questionnaire Administration Wiki	0.03
drug2692	Standard care Wiki	0.03
drug3408	placebo Wiki	0.02
drug2707	Standard of care Wiki	0.02
drug2413	Remdesivir Wiki	0.02

Correlated MeSH Terms (87)

---

	Name (Synonyms)	Correlation
D007239	Infection NIH	0.66
D045169	Severe Acute Respiratory Syndrome NIH	0.33
D018352	Coronavirus Infections NIH	0.28
D012141	Respiratory Tract Infections NIH	0.20
D014777	Virus Diseases NIH	0.18
D003333	Coronaviridae Infections NIH	0.18
D012327	RNA Virus Infections NIH	0.18
D003428	Cross Infection NIH	0.14
D018357	Respiratory Syncytial Virus Infections NIH	0.13
D030341	Nidovirales Infections NIH	0.11
D021821	Communicable Diseases, Emerging NIH	0.11
D058345	Asymptomatic Infections NIH	0.11
D009410	Nerve Degeneration NIH	0.11
D004066	Digestive System Diseases NIH	0.09
D018184	Paramyxoviridae Infections NIH	0.09
D005767	Gastrointestinal Diseases NIH	0.09
D001997	Bronchopulmonary Dysplasia NIH	0.08
D055732	Pulmonary Aspergillosis NIH	0.08
D008595	Menorrhagia NIH	0.08
D006929	Hyperaldosteronism NIH	0.08
D001229	Aspergillosis, Allergic Bronchopulmonary NIH	0.08
D054559	Hyperphosphatemia NIH	0.08
D004314	Down Syndrome NIH	0.08
D011649	Pulmonary Alveolar Proteinosis NIH	0.08
D003384	Coxsackievirus Infections NIH	0.08
D004660	Encephalitis NIH	0.08
D054990	Idiopathic Pulmonary Fibrosis NIH	0.08
D000309	Adrenal Insufficiency NIH	0.08
D007008	Hypokalemia NIH	0.08
D012140	Respiratory Tract Diseases NIH	0.07
D014808	Vitamin D Deficiency NIH	0.06
D009080	Mucocutaneous Lymph Node Syndrome NIH	0.06
D000075902	Clinical Deterioration NIH	0.06
D014552	Urinary Tract Infections NIH	0.06
D009181	Mycoses NIH	0.06
D001228	Aspergillosis NIH	0.06
D009101	Multiple Myeloma NIH	0.06
D011565	Psoriasis NIH	0.06
D003139	Common Cold NIH	0.06
D000073296	Noncommunicable Diseases NIH	0.06
D006331	Heart Diseases NIH	0.06
D000257	Adenoviridae Infections NIH	0.06
D017250	Caliciviridae Infections NIH	0.06
D054219	Neoplasms, Plasma Cell NIH	0.06
D011014	Pneumonia NIH	0.05
D011024	Pneumonia, Viral NIH	0.05
D058070	Asymptomatic Diseases NIH	0.05
D000163	Acquired Immunodeficiency Syndrome NIH	0.05
D007251	Influenza, Human NIH	0.04
D012120	Respiration Disorders NIH	0.04
D009164	Mycobacterium Infections NIH	0.04
D001289	Attention Deficit Disorder with Hyperactivity NIH	0.04
D009362	Neoplasm Metastasis NIH	0.04
D006470	Hemorrhage NIH	0.04
D003550	Cystic Fibrosis NIH	0.04
D015535	Arthritis, Psoriatic NIH	0.04
D008171	Lung Diseases, NIH	0.04
D004198	Disease Susceptibility NIH	0.04
D008175	Lung Neoplasms NIH	0.04
D009369	Neoplasms, NIH	0.03
D012128	Respiratory Distress Syndrome, Adult NIH	0.03
D011248	Pregnancy Complications NIH	0.03
D007153	Immunologic Deficiency Syndromes NIH	0.03
D007154	Immune System Diseases NIH	0.03
D003327	Coronary Disease NIH	0.03
D055371	Acute Lung Injury NIH	0.03
D012127	Respiratory Distress Syndrome, Newborn NIH	0.03
D005355	Fibrosis NIH	0.03
D050177	Overweight NIH	0.03
D011658	Pulmonary Fibrosis NIH	0.03
D007676	Kidney Failure, Chronic NIH	0.03
D004630	Emergencies NIH	0.03
D029424	Pulmonary Disease, Chronic Obstructive NIH	0.03
D001172	Arthritis, Rheumatoid NIH	0.03
D004417	Dyspnea NIH	0.03
D007674	Kidney Diseases NIH	0.03
D008173	Lung Diseases, Obstructive NIH	0.03
D015658	HIV Infections NIH	0.02
D013577	Syndrome NIH	0.02
D017563	Lung Diseases, Interstitial NIH	0.02
D001168	Arthritis NIH	0.02
D020141	Hemostatic Disorders NIH	0.02
D001778	Blood Coagulation Disorders NIH	0.02
D006973	Hypertension NIH	0.02
D002318	Cardiovascular Diseases NIH	0.01
D004194	Disease NIH	0.01
D016638	Critical Illness NIH	0.01

Correlated HPO Terms (30)

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	Name (Synonyms)	Correlation
HP:0011947	Respiratory tract infection HPO	0.20
HP:0002180	Neurodegeneration HPO	0.11
HP:0002905	Hyperphosphatemia HPO	0.08
HP:0002900	Hypokalemia HPO	0.08
HP:0000846	Adrenal insufficiency HPO	0.08
HP:0000132	Menorrhagia HPO	0.08
HP:0002383	Encephalitis HPO	0.08
HP:0006517	Intraalveolar phospholipid accumulation HPO	0.08
HP:0000859	Hyperaldosteronism HPO	0.08
HP:0011024	Abnormality of the gastrointestinal tract HPO	0.06
HP:0100512	Low levels of vitamin D HPO	0.06
HP:0003765	Psoriasiform dermatitis HPO	0.06
HP:0006775	Multiple myeloma HPO	0.06
HP:0002090	Pneumonia HPO	0.05
HP:0007018	Attention deficit hyperactivity disorder HPO	0.04
HP:0002088	Abnormal lung morphology HPO	0.04
HP:0100526	Neoplasm of the lung HPO	0.04
HP:0002664	Neoplasm HPO	0.03
HP:0002721	Immunodeficiency HPO	0.03
HP:0002206	Pulmonary fibrosis HPO	0.03
HP:0001370	Rheumatoid arthritis HPO	0.03
HP:0000077	Abnormality of the kidney HPO	0.03
HP:0006510	Chronic pulmonary obstruction HPO	0.03
HP:0002098	Respiratory distress HPO	0.03
HP:0006536	Pulmonary obstruction HPO	0.03
HP:0006515	Interstitial pneumonitis HPO	0.02
HP:0001369	Arthritis HPO	0.02
HP:0001928	Abnormality of coagulation HPO	0.02
HP:0000822	Hypertension HPO	0.02
HP:0001626	Abnormality of the cardiovascular system HPO	0.01

Primary Outcomes

Description: Number and severity of adverse events

Measure: Phase 1: Frequency and Severity of Adverse Events (AE)

Time: Up to 12 months

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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

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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

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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

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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

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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

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Description: Number and severity of adverse events

Measure: Phase 2: Frequency and Severity of Adverse Events (AE)

Time: up to 12 months

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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

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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

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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

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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

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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

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Description: For ventilatory support subjects, the days with supplemental oxygen-free.

Measure: Supplemental oxygen-free days

Time: Up to 28 days

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Description: Proportion of subjects who need invasive or non-invasive ventilation

Measure: Proportion of subjects requiring ventilation

Time: Up to 28 days

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Primary Outcomes

Description: Determination of sustained absence of disease-specific symptoms and signs.

Measure: Symptoms and signs

Time: 1 year

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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.

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Primary Outcomes

Description: The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.

Measure: Time-Weighted Average Change in Respiratory Syncytial Viral (RSV) Load From Baseline to Day 5

Time: Baseline to Day 5

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Secondary Outcomes

Description: The Flu-PRO is a patient-reported outcome questionnaire utilized as a standardized method for evaluating symptoms of influenza. Flu-PRO Score was calculated as the mean of 38 individual scores. Individual scores ranged from 0 (no symptoms) to 4 (worst symptoms). The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.

Measure: Time-weighted Average Change in the Flu-PRO Score From Baseline to Day 5

Time: Baseline to Day 5

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Measure: Number of Hospitalization-Free Days Following Presatovir Administration

Time: Up to Day 28

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Description: The adjusted rate of unplanned medical encounters (clinic visits, emergency room visits, urgent care visits, and rehospitalizations) related to a respiratory illness after initial hospital discharge through Day 28 will be assessed. Event rate was calculated as the total number of unplanned medical encounters divided by the total number of participants. The mean values presented were adjusted for stratification factor.

Measure: Rate of Unplanned Medical Encounters

Time: Up to Day 28

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Primary Outcomes

Description: The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factors.

Measure: Time-weighted Average Change in Nasal Respiratory Syncytial Viral (RSV) Load From Baseline to Day 9

Time: Baseline to Day 9

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Secondary Outcomes

Measure: Number of Supplemental O2-Free Days Through Day 28

Time: Up to Day 28

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Measure: Percentage of Participants Developing Respiratory Failure Requiring Mechanical Ventilation Through Day 28

Time: Up to Day 28

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Measure: Percentage of All-Cause Mortality Among Participants Through Day 28

Time: Up to Day 28

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Primary Outcomes

Measure: Freedom from new or progressive chronic lung allograft dysfunction

Time: 180 days

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Measure: Death

Time: 180 days

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Secondary Outcomes

Measure: Respiratory virus symptom score

Time: 7 days

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Measure: Acute rejection

Time: 180 days

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Measure: Lymphocytic bronchiolitis

Time: 180 days

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Measure: Donor-specific antibodies

Time: 180 days

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Measure: Chronic lung allograft dysfunction

Time: 365 days

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Primary Outcomes

Description: Based on patient diary data. Criteria of alleviation of all ARVI symptoms: oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with ≤3-point of the total score (TS) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom). TS ranges from 0 to 30, and the higher scores mean a worse outcome.

Measure: Time to Alleviation of All ARVI Symptoms.

Time: 14 days of observation.

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Secondary Outcomes

Description: Based on patient diary data. Oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period).

Measure: Time to Normalization of Body Temperature.

Time: 14 days of observation.

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Description: Based on patient diary data. Absence of flu-like nonspecific symptoms/presence of one mild flu-like nonspecific symptom.

Measure: Time to Alleviation of Flu-like Nonspecific Symptoms.

Time: 14 days of observation.

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Description: Based on patient diary data. Absence of respiratory symptoms/presence of one mild respiratory symptom.

Measure: Time to Alleviation of Respiratory Symptoms.

Time: 14 days of observation.

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Description: Based on patient diary data. The total score (TS) ranges from 0 to 30 consisting of 4 flu-like nonspecific (decreased activity/weakness, poor appetite/refusal to eat, sick appearance, sleep disturbance) and 6 respiratory (runny nose, stuffy nose/nasal congestion, sneezing, hoarseness, sore throat, cough) symptoms according to the 4-point scale for each symptom (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). TS ranges from 0 to 30, and the higher scores mean a worse outcome.

Measure: Flu-like Nonspecific and Respiratory Symptoms Total Score (TS) for Days 2-6.

Time: On days 2-6 of the observation period.

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Description: Based on the area under the curve of TS for days 2-6, according to the patient diary. The total score (TS) will be calculated based on the severity of each ARVI symptom (sum of 11 symptoms = body temperature, flu-like nonspecific symptoms (4 symptoms) and respiratory symptoms (6 symptoms) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TS the absolute oral temperature values, measured in degrees Celsius, will be converted into relative units (or points), given the following gradations: ≤37.5С = 0 point; 37.6-38.1C = 1 point; 38.2-38.8C = 2 points; ≥38.90С = 3 points. For total score minimum and maximum scores are 0 and 33, where higher values represent a worse outcome.

Measure: ARVI Severity.

Time: On days 2-6 of the observation period.

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Description: Based on patient diary data. Criteria of recovery/alleviation of all ARVI symptoms: oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with ≤3-point of the total score (TS) according to the 4-point scale for each flu-like nonspecific and respiratory symptom (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom).

Measure: Percentage of Recovered Patients.

Time: On days 2-6 of the observation period.

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Description: Based on patient diary data. The number of intakes of prescribed antipyretics.

Measure: Rates of Antipyretics Use Per Patient.

Time: On days 1- 5 of the treatment period.

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Description: Based on patient diary data. The disease worsening: ARVI complications, including those requiring antibiotics; hospitalization).

Measure: Percentage of Patients With Worsening of Illness.

Time: 14 days of observation peiod.

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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

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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

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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

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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

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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

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Description: Measured by death from all causes

Measure: Efficacy in reduction of mortality

Time: Day 26

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

Measure: Antiviral effect

Time: Day 26

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

Measure: Efficacy on clinical improvement

Time: Day 26

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Description: Measured by change in the Modified Jackson Cold Score

Measure: Efficacy on the respiratory symptoms

Time: Day 26

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Primary Outcomes

Description: Viability of enteroids as determined by microscopy

Measure: Establishment of human intestinal stem cell-derived enteroids

Time: An average of three months

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Primary Outcomes

Description: RSV viral load AUC will be determined from immediately prior to first dose of study drug through Day 5. The RSV viral load is measured by the RSV viral load as measured by quantitative real-time reverse transcription-polymerase chain reaction (qRT-PCR) assay of nasal swabs.

Measure: Respiratory Syncytial Virus (RSV) Viral Load Area Under Curve (AUC) from Immediately Prior to First Dose of Study Drug Through Day 5

Time: Baseline through Day 5

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Secondary Outcomes

Description: RSV viral load and change from baseline over time will be measured by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Measure: RSV Viral Load and Change from Baseline Over Time

Time: Baseline through Day 21

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Description: RSV viral load AUC will be determined by quantitative qRT-PCR assay of nasal swabs.

Measure: RSV Viral Load AUC from Immediately Prior to First Dose of Study Drug (Baseline) Through Days 3, 8, and 14

Time: Baseline through Days 3, 8 and 14

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Description: Time to undetectable RSV viral load (per the detection limit of the assay used in the study) will be reported.

Measure: Time to Undetectable RSV Viral Load

Time: Up to 21 days

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Description: Proportion of participants with undetectable RSV viral load will be reported.

Measure: Proportion of Participants with Undetectable RSV Viral Load at each timepoint

Time: Up to 21 days

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Description: Duration of signs and symptoms of RSV disease will be assessed by PRESORS. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues).

Measure: Duration of Signs and Symptoms of RSV Disease Assessed by the Pediatric RSV Electronic Severity and Outcome Rating Scale (PRESORS)

Time: Up to 21 days

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Description: Severity of RSV disease will be assessed by PRESORS. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues).

Measure: Severity of RSV Disease Assessed by PRESORS

Time: Up to 21 days

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Description: Change from baseline in parent(s)/caregiver(s) PRESORS scores (worsening or improvement) will be reported. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues) daily by parent/caregiver.

Measure: Change from Baseline in Parent(s)/Caregiver(s) PRESORS Scores

Time: Baseline up to 21 days

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Description: Change from baseline in clinician PRESORS scores (worsening or improvement) will be reported. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues) by clinician.

Measure: Change from Baseline in Clinician PRESORS Scores

Time: Baseline up to 21 days

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Description: Time to resolution (that is, to none or mild) of RSV symptoms will be recorded.

Measure: Time to Resolution of RSV Symptoms

Time: Up to 21 days

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Description: Time to improvement based on general questions on overall health will be reported.

Measure: Time to Improvement on Overall Health

Time: Up to 21 days

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Description: Proportion of participants with improvement or worsening of RSV disease based on general questions on overall health will be reported.

Measure: Proportion of Participants with Improvement or Worsening of RSV Disease

Time: Up to 21 days

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Description: Time to return to pre-RSV health as rated by the parent(s)/caregiver(s) will be recorded.

Measure: Time to Return to Pre-RSV Health as Rated by the Parent(s)/Caregiver(s)

Time: Up to 21 days

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Description: Proportion of participants with vital signs (heart rate, respiratory rate, body temperature and peripheral capillary oxygen saturation [SpO2]) abnormalities will be reported.

Measure: Proportion of Participants with Vital Sign Abnormalities

Time: Up to 28 days

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Description: Proportion of participants with abnormal body temperature will be reported.

Measure: Proportion of Participants with Abnormal Body Temperature as Measured by the Parent(s)/Caregiver(s)

Time: Up to 28 days

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Description: Proportion of participants who require (re)hospitalization during treatment and follow-up will be reported.

Measure: Proportion of Participants who Require (re)Hospitalization During Treatment and Follow-up

Time: Up to 21 days

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Description: Time return to age-adjusted normal values for vital signs (heart rate, respiratory rate, and/or blood oxygen) for participants with risk factors for severe RSV Disease will be recorded.

Measure: Time Return to Age-Adjusted Normal Values for vital signs (Heart Rate, Respiratory Rate, and/or Blood Oxygen) for Participants with Risk Factors for Severe RSV Disease

Time: Up to 21 days

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Description: Time to discharge (from initial admission and from initiation of treatment) will be recorded for Cohort 1 only.

Measure: Cohort 1: Time to Discharge

Time: Up to 21 days

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Description: Proportion of participants who require to be admitted to the ICU will be reported for Cohort 1 only.

Measure: Cohort 1: Proportion of Participants who Require to be Admitted to Intensive Care Unit (ICU)

Time: Up to 21 days

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Description: In the event that a participant requires ICU, admission, the duration of need for ICU stay will be reported for Cohort 1 only.

Measure: Cohort 1: Duration of ICU Stay

Time: Up to 21 days

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Description: Proportion of participants who require supplemental oxygen will be reported for Cohort 1 only.

Measure: Cohort 1: Proportion Participants who Require Supplemental Oxygen

Time: Up to 21 days

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Description: Duration of the oxygen supplementation in participants requiring will be reported for Cohort 1 only.

Measure: Cohort 1: Duration of Supplemental Oxygen

Time: Up to 21 days

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Description: Proportion of participants who require non-invasive ventilator support (for example [e.g], continuous positive airway pressure) status will be reported for Cohort 1 only.

Measure: Cohort 1: Proportion of Participants who Require Non-invasive Ventilator Support

Time: Up to 21 days

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Description: Proportion of participants who require invasive ventilator support (e.g, endotracheal-mechanical ventilation) will be reported for Cohort 1 only.

Measure: Cohort 1: Proportion of Participants who Require Invasive Mechanical Ventilation Support

Time: Up to 21 days

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Description: Duration of non-invasive ventilator support (e.g, continuous positive airway pressure) to deliver oxygen will be measured for Cohort 1 only.

Measure: Cohort 1: Duration of Non-invasive Ventilator Support

Time: Up to 21 days

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Description: Duration of invasive ventilator support (e.g, endotracheal-mechanical ventilation) to deliver oxygen will be measured for Cohort 1 only.

Measure: Cohort 1: Duration of Invasive Ventilator Support

Time: Up to 21 days

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Description: Proportion of participants who need (defined by <50% of normal oral intake) hydration and/or feeding by IV administration or nasogastric tube will be reported for Cohort 1 only.

Measure: Cohort 1: Proportion of Participants who Need Hydration and/or Feeding by Intravenously (IV) Administration or Nasogastric Tube

Time: Up to 21 days

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Description: Time to clinical stability is defined as the time from initiation of study treatment until the time at which the following criteria are met: Time to return to age-adjusted normal values for otherwise healthy and pre-RSV infection status for participants with risk factor for severe RSV disease (heart rate, respiratory rate, blood oxygen level), no more oxygen supplementation or otherwise healthy participants and with risk factor(s) for severe RSV disease and no more intravenously (IV)/nasogastric tube feeding/hydration) in otherwise healthy participants or return to pre-RSV status of IV/nasogastric tube feeding/hydration in participants with risk factor for severe RSV disease for Cohort 1 only.

Measure: Cohort 1: Time to Clinical Stability with Clinical Stability Evaluated by the Investigator

Time: Up to 21 days

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Description: Time from initiation of study treatment until SpO2 >=92 percentage (%) and SpO2 >= 95% on room air among participants who were not on supplemental oxygen prior to the onset of respiratory symptoms will be reported for Cohort 1 only.

Measure: Cohort 1: Time From Initiation of Study Treatment Until Peripheral Capillary Oxygen Saturation (SpO2) >= 92% and SpO2 >= 95% on Room Air Among Participants who Were not on Supplemental Oxygen Prior to Onset of Respiratory Symptoms

Time: Up to 21 days

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Description: An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Measure: Percentage of Participants with Adverse Events

Time: Up to 28 days

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Description: Percentage of participants with abnormal laboratory (serum chemistry, hematology and urinalysis) findings will be reported.

Measure: Percentage of Participants with Abnormal Laboratory Findings

Time: Up to 28 days

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Description: Percentage of participants with abnormal ECGs findings will be reported.

Measure: Percentage of Participants with Abnormal Electrocardiograms (ECGs) Findings

Time: Up to 21 days

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Description: Plasma Concentrations of JNJ-53718678 will be evaluated and determined by population pharmacokinetics (popPK) modelling.

Measure: Plasma Concentrations of JNJ-53718678

Time: Days 1 and 3

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Description: Number of medical care encounters and treatments (including physician or emergency room visits, tests and procedures, and medications, surgeries and other procedures) will be reported.

Measure: Medical Resource Utilization

Time: Up to 28 days

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Description: Acceptability and palatability of the JNJ-53718678 formulation will be assessed through a questionnaire asking about the child's reaction when given the medicine, completed by parent(s)/caregiver(s) after last dosing.

Measure: Acceptability and Palatability of the JNJ-53718678 Formulation as Assessed by Parent(s)/Caregiver(s)

Time: Day 8

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Description: Number of participants with changes in the RSV F-gene compared with baseline sequences will be assessed by sequencing of the viral genome.

Measure: Number of Participants with Post-baseline Changes in the RSV F-gene Compared with Baseline Sequences

Time: Up to 21 days

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Primary Outcomes

Description: Removal of all oxygen support (with stable SpO2)

Measure: Percent of subjects who Return to Room Air (RTRA) (main study)

Time: by Day 28

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Measure: Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study)

Time: Day 14

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Secondary Outcomes

Measure: All-cause mortality rate (main study)

Time: at Day 28

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Measure: Percent of subjects who Return to Room Air (RTRA) (main study)

Time: by Day 21

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Measure: Time (in days) to RTRA (main study)

Time: Days 10, 14, 21, 28

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Measure: Percent of subjects who achieve clinical stability (main study)

Time: by Day 28

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Measure: Percent of subjects discharged (without mortality and hospice) (main study)

Time: by Days 14, 21, 28 and 35

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Measure: Time (in days) to first hospital discharge (without hospice) (main study)

Time: through Day 35

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Measure: Total number of inpatient days (main study)

Time: up to Day 35

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Measure: Baseline SAD-RV infection-related mortality rate (main study)

Time: at Day 28

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Measure: Baseline SAD-RV infection-related mortality rate (main study)

Time: at Day 35

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Measure: All-cause mortality rate (main study)

Time: at Day 35

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Measure: Change in pulmonary function (FEV1% predicted) (main study)

Time: Day 1, Day 7, Day 14, Day 28

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Measure: Time to improved COVID19 clinical status (Sub-study)

Time: Day 5, Day 10, Day 21, Day 28

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Measure: Time to RTRA

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

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Measure: Time to Clinical stability

Time: Day 14, Day 21, Day 28

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Measure: Time to SARS-CoV-2 RNA in the respiratory specimens being undetectable

Time: Day 5, Day 10, Day 14, Day 21, Day 28

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Measure: Time to Clinical deterioration

Time: Day 5, Day 10, Day 14, Day 21, Day 28

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Measure: Time to Discharge from hospital (without readmission before Day 28).

Time: Day 14, Day 21, Day 28

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Measure: Time to Death (all causes)

Time: Day 14, Day 21, Day 28

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Primary Outcomes

Description: Species count in fecal sample

Measure: Gut microbiome species richness

Time: 1 Day

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Description: Measurement of blood lipids

Measure: Lipids

Time: 3 days

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Description: Measurement of blood glucose

Measure: Glucose

Time: 11 days

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Description: Record of sleep pattern using a wearable device (i.e. fitness watch)

Measure: Sleep

Time: 10 days

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Description: Record of physical activity using a wearable device (i.e. fitness watch)

Measure: Physical activity

Time: 10 days

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Description: Record of hunger and appetite patterns using a digital app

Measure: Hunger and appetite assessment

Time: 10 days

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Secondary Outcomes

Description: C-peptide

Measure: Glucose metabolism

Time: 3 days

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Description: Weighed food log

Measure: Dietary assessment

Time: 10 days

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Description: Weight (kg)

Measure: Anthropometry

Time: 1 day

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Description: Height (cm)

Measure: Anthropometry

Time: 1 day

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Description: Hip and waist circumference (cm)

Measure: Anthropometry

Time: 1 day

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Description: Lipoprotein concentration (mol/L), lipoprotein composition (mol/L), glycoprotein acetyl concentration (mol/L), ketone bodies concentration (mol/L)

Measure: Metabolomics by NMR analysis

Time: 1 day

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Description: Diet history and portion size questionnaire about the preceding month, using the Diet History Questionnaire 3 from National Cancer Institute.

Measure: Dietary assessment

Time: 1 month

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Description: Self-reported demographic and physical health symptoms, or lack thereof, reported on a daily basis.

Measure: Covid-19 symptom assessment

Time: 6 months

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Primary Outcomes

Description: Common type: Fever, respiratory tract and other symptoms, imaging examination shows pneumonia; Severe type (meeting any of the following）: (1) Respiratory distress，respiratory rate ≥ 30 bmp; (2) Oxygen saturation ≤ 93%；(3)PaO2/FiO2 ≤ 300mmHg. Critically severe type (meeting any of the following）: (1) Respiratory failure requiring mechanical ventilation; (2) Shock; (3) Combining with other organ failures, requiring ICU monitoring and treatment.

Measure: Number of participants with improvement from severe type to common type

Time: 2 weeks

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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

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Secondary Outcomes

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

Measure: The disease prorogation-temperature

Time: Day 0 till day 21

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

Measure: The disease prorogation-respiratory function 1

Time: Day 0 till day 21

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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

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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

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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

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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

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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

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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

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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

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Primary Outcomes

Description: after the end of this study, investigators calculate and sum up the total evaluated population and positively diagnosed population, then check the ROC of this system, finally to calculate the sensitivity and accuracy of this self-test and self-alert system

Measure: positive number diagnosed by national guideline in the evaluated population

Time: 5 months

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Secondary Outcomes

Description: after the end of this study, investigators calculate the proportion and distribution of evaluated people with normal and abnormal scores

Measure: distribution map of evaluated people

Time: 5 month

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Description: after the end of this study, investigators sent the feedback inform to every evaluated people and collect and analysis the response to find out whether this applet can help them in the following surveillance or medical treatment. And how it works.

Measure: Effect of medical guidance by designated feedback questionnaire

Time: 5 month

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Description: after the end of this study, investigators sent the designated mental scale including anxiety, and collect the response and draw the conclusion.

Measure: mental scale of relief the mental anxiety and avoid unnecessary outpatient

Time: 5 month

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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.

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Measure: Volume of distribution (V) or apparent oral volume of distribution (V/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.

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Measure: Elimination rate constant (ke) 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.

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Measure: Half-life (t1/2) 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: Absorption rate constant (ka) 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.

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Measure: AUC (area under the curve) 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.

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Measure: Maximum concentration (Cmax) 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.

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Measure: Time to achieve maximum concentration (Tmax) 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.

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Primary Outcomes

Measure: The death of newborns with COVID-19

Time: The date of discharge，an average of 4 weeks after the admission

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Description: Neonates born to mothers with COVID-19 will be tested for SARS-CoV-2 after birth.Confirmed cases will meet the diagnosed criterion provided by National Health and Health Commission and the Chinese perinatal-neonatal SARS-CoV-2 Committee.

Measure: The SARS-CoV-2 infection of neonates born to mothers with COVID-19

Time: within 7days after the admission

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Secondary Outcomes

Description: The standardized DDST consists of 104 items and covers four areas of development: (a) personal/social, (b) fine motor/adaptive, (c) language, and (d) gross motor. In the present study, three trained professionals examined the children. The results of the DDST could be normal (no delays), suspect (2 or more caution items and/or 1 or more delays), abnormal (2 or more delays) or untestable (refusal of one or more items completely to the left of the age line or more than one item intersected by the age line in the 75-90% area). The children with suspect or abnormal results were retested 2 or 3 weeks later.

Measure: The Chinese standardized Denver Developmental Screening Test (DDST) in neonates with or with risk of COVID-19

Time: Infants ( ≥35 weeks）are at 6 months after birth;Infants（＜ 35weeks） are at a corrected age of 6 months.

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Description: The small for gestational age infant is defined as live-born infants weighting less than the 10th percentile for gestational age (22 weeks+0 day to 36 weeks+6days).

Measure: The small for gestational age newborns in the neonates born to mothers with COVID-19

Time: at birth

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Description: The preterm infant is defined as the gestational age less than 37weeks+0day.The gestational age range is 22 weeks+0 day to 36 weeks+6days

Measure: The preterm delivery of neonates born to mothers with COVID-19

Time: at birth

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Description: Infants with SARS-CoV-2 infection are classified into asymptomatic, mild infection and severe infection, according to the expert consensus provided by the Chinese

Measure: The disease severity of neonates with COVID-19

Time: through study completion, estimated an average of 2 weeks

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Primary Outcomes

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

Measure: Screening accuracy

Time: 1 month

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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

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Primary Outcomes

Description: Fever to normal time (day)

Measure: Fever to normal time (day)

Time: 30 days

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

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

Time: 30 days

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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

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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

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Secondary Outcomes

Description: Mortality from all causes

Measure: Mortality

Time: 28 days

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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

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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

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Primary Outcomes

Description: Percent of subjects who have returned to room air

Measure: Percent of subjects who have returned to room air

Time: 7 days

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Description: Percent change of subjects return to baseline oxygen requirement by Day 7 compared to Day 1

Measure: Percent change of subjects return to baseline oxygen requirement

Time: 7 days

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Primary Outcomes

Description: Sars-CoV2 seroconversion is defined by a T0 sample with no specific antibody (negative) and M3 sample with the presence of specific IgG.

Measure: Quantify the proportion of patients with documented Sars-CoV2 infection among medical and paramedical staff

Time: 3 months

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Secondary Outcomes

Description: "Age, gender, type of staff, medical staff: resident, Clinic Chief or University Hospital Assistant (CCA / AHU), Associate Practitioner (PA), Contractual Hospital Practitioner (PHC), Hospital Practitioner (PH), Lecturer-Hospital Practitioner (MCU-PH) , University Professor-Hospital Practitioner (PUPH) non-medical staff: nursing assistants (AS), nurses (IDE), physiotherapist, managers, others, Seniority in the profession (number of years) Service tenure (years), Night, day, day or mixed work, Type of service: emergency department, infectious disease service, ICU), Type of hospital (firstline reference hospital or not), Documented contact with a confirmed patient."

Measure: Identification of risk factors for seroconversion

Time: 3 months

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Description: "Seroconversion without clinical manifestation (fever, body aches, headache, sweating, chills + respiratory symptoms (cough dyspnea, sputum) or digestive (nausea / vomiting diarrhea abdominal pain) reported via the weekly self-monitoring booklet. The asymptomatic characteristics will be determined by an adjudication committee, in the light of the weekly self-monitoring notebooks, without knowing the results of the serologies."

Measure: Quantify the proportion of asymptomatic infections among staff who have seroconverted

Time: 3 months

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Description: "Description of symptomatic infections Clinical manifestations associated with seroconversion. On the intermediate sample if necessary, performed within 10 days of the start of a clinical picture compatible with an acute Sars-CoV2 infection (fever, body aches, headache, sweating, chills + respiratory picture (cough dyspnea, sputum, ) or digestive (nausea / vomiting diarrhea abdominal pain) "

Measure: " Describe symptomatic infections for personnel developing acute clinical (respiratory or digestive) viral syndrome "

Time: 3 months

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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 15

Time: 15 days

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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 28

Time: 28 days

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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

Measure: 28-Day Mortality

Time: 28 days

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

Measure: 90-Day Mortality

Time: 90 days

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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

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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

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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

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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

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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

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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

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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

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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: 10 days

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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

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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

Time: 10 days

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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

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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

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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

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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

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Primary Outcomes

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

Measure: COVID-19 diagnosis

Time: 14 days

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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

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Other Outcomes

Description: Mean/ Median in the two groups

Measure: Total number of quarantine days

Time: 14 days

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Description: Percentage in the two groups

Measure: Proportion of healthcare providers requiring quarantine

Time: 14 days

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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

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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

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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

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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

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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

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Secondary Outcomes

Description: Number of Invalid results

Measure: Reliability of the test

Time: 30 days

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Description: Number of healthcare workers that become positive for COVID-19 IgM or IgG

Measure: Positive HCW

Time: 60 days

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Description: Number of Chronic Patients that become positive for COVID-19 IgM or IgG

Measure: Number of Chronic Patients

Time: 60 days

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Primary Outcomes

Measure: Number of participants who experience inpatient admission

Time: 2 months

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Secondary Outcomes

Measure: Number of participants admitted to the intensive care unit

Time: 2 months

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Measure: Number of participants requiring mechanical ventilation

Time: 2 months

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Measure: Number of deceased participants

Time: 2 months

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Primary Outcomes

Description: Maneuvarability of the remote control MCE system

Measure: Technical success

Time: During the procedure

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Secondary Outcomes

Description: Complete observation of the mucosa (>90% of the mucosa observed) in gastric cardia, fundus, body, angulus, antrum and pylorus

Measure: Clinical success

Time: During the procedure

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Description: Adverse events during and after the procedure

Measure: Adverse events

Time: During and within 2 weeks after the procedure

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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

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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

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Secondary Outcomes

Measure: Safety evaluation, as measured by AEs, Adverse Reactions (ARs), SAEs, Serious ARs (SARs)

Time: 30 days

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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

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Description: Mortality

Measure: Cohort 1: Day 30 mortality

Time: 30 days

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Description: NEWS2

Measure: Cohort 1: Change in NEW(2) score from baseline to day 30

Time: 30 days

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Description: ICU

Measure: Cohort 1: Admission to ICU

Time: 30 days

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Description: invasive mechanical ventilation or ECMO

Measure: Cohort 1: Use of invasive mechanical ventilation or ECMO

Time: 30 days

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Description: Nasal or high-flow oxygen

Measure: Cohort 1: Duration of supplemental oxygen (days)

Time: 30 days

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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

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Description: No of new COVID-19 infections in the household

Measure: Cohort 2: Number participant-reported secondary infection of housemates

Time: 30 days

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Description: Hospital admission

Measure: Cohort 2: Time to hospital admission related to COVID-19 infection

Time: 30 days

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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

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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

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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

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Description: Safety of siltuximab treatment

Measure: Safety Improvement of the lung function assessed by radiologic findings

Time: 30 days

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Description: Evaluate the effect of siltuximab on inflammatory parameters (CRP)

Measure: the effect on inflammatory parameters

Time: 30 days

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Description: Correlation of outcomes with IL-6 levels

Measure: Correlation of outcomes with IL-6 levels

Time: 30 days

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Primary Outcomes

Measure: Number of days alive and discharged from hospital within 14 days

Time: 14 days

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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

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Measure: Admitted to intensive care unit, if admitted to ICU then length of stay

Time: 14 days

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Measure: Have used Non-invasive ventilation (NIV) during hospitalization

Time: 14 days

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Measure: Mortality

Time: 30 days

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Measure: Length of hospitalization

Time: 14 days

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Measure: Days alive and discharged from hospital

Time: 30 days

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Measure: Mortality

Time: 90 days

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Measure: Mortality

Time: 365 days

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Measure: Number of readmissions (all causes)

Time: 30 days

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Measure: Number of days using non-invasive ventilation (NIV)

Time: 14 days

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Description: Delta PaO2 measured in arterial puncture

Measure: Change in patient's oxygen partial pressure

Time: 4 days

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Description: Delta PaCO2 measured in arterial puncture

Measure: Change in patient's carbondioxid partial pressure

Time: 4 days

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Description: pH measured in arterial puncture

Measure: Level of pH in blood

Time: 4 days

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Measure: Time for no oxygen supplement (or regular oxygen supplement "LTOT")

Time: 14 days

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Primary Outcomes

Measure: Point prevalence of COVID-19 infection

Time: Baseline up to 6 months

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Secondary Outcomes

Measure: Incidence of COVID-19 infection

Time: Baseline up to 6 months

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Measure: Percentage of subjects presenting fever or respiratory symptoms

Time: Baseline up to 6 months

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Measure: Evaluate the relationship between COVID-19 infection and chronic pharmacological treatments

Time: Baseline up to 6 months

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Measure: Evaluate the relationship between COVID-19 infection and comorbid medical conditions

Time: Baseline up to 6 months

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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

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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

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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

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Primary Outcomes

Description: Dichotomous categorical variable measured by "yes" or "no" responses

Measure: COVID-19 disease diagnosis

Time: Change from Baseline COVID-19 disease diagnosis at 8 weeks

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Secondary Outcomes

Description: Dichotomous categorical variable measured by "slight" or "severe" responses

Measure: COVID-19 disease symptoms severity

Time: Change from Baseline COVID-19 disease symptoms severity at 8 weeks

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Description: Polytomous categorical variable measured by adverse effects responses

Measure: Adverse effects

Time: Change from Baseline adverse effects at 8 weeks

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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

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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

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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

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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

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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

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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

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Primary Outcomes

Measure: Time to improvement on a 7-point ordinal scale as compared to baseline

Time: 14 days or discharge

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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

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Measure: Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples

Time: 14 days or discharge

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Measure: In-hospital mortality

Time: 14 days or discharge

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Measure: Mean change in NEWS2 score from baseline

Time: 14 days or discharge

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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

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Measure: Reduction from baseline of NRS for cough

Time: 14 days or discharge

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Measure: Reduction from baseline of NRS for nausea

Time: 14 days or discharge

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Measure: Time to normalization of fever for at least 48 hours

Time: 14 days or discharge

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Measure: Time to improvement in oxygenation for at least 48 hours

Time: 14 days or discharge

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Primary Outcomes

Measure: Correlation between nasal and deep PCR positivity for Covid-19 patients performed and all predictors for Covid-19 patients performed within 24 hours of admission to ICU

Time: within 24 hours of admission to ICU

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Secondary Outcomes

Description: Assessment of viral, bacterial, fungal and parasitic rate in confirmed and unconfirmed patients for COVID-19

Measure: Coinfections

Time: during ICU stay, up to 28 days

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Description: it will be reported the evolution of respiratory dysfunction in patients infected with COVID-19 admitted to ICU during their stay and requiring mechanical ventilation (during, Pao2/FIO2 ratio,,features of artificial ventilation features of extra-bodied respiratory assistance)

Measure: Respiratory dysfunction requiring mechanical ventilation

Time: during ICU stay, up to 28 days

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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).

Measure: Sequential Organ Failure Assessment (SOFA) Score

Time: during ICU stay, up to 28 days

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Description: APS II was designed to measure the severity of disease for patients admitted to Intensive care units 24 hours after admission to the ICU, the measurement has been completed and resulted in an integer point score between 0 and 163 and a predicted mortality between 0% and 100%.

Measure: SAPS II score

Time: at admission

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Description: The DIC Score was developed by the The International Society of Thrombosis and Haemostasis (ISTH.) The DIC score calculator accounts of the following four parameters.Each of the four parameters evaluated above have values that are weighted with a number of points varying from 0 to 3. By summing the points given to the choices, a final result between 0 and 8 is obtained

Measure: Disseminated Intravascular Coagulation (DIC) score

Time: during ICU stay, up to 28 days

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Measure: Number of days on vasopressive amines

Time: during ICU stay, up to 28 days

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Measure: Occurrence of an event of venous or arterial thromboembolic disease

Time: during ICU stay, up to 28 days

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Measure: Number of days with extra renal treatment (ERA)

Time: during ICU stay, up to 28 days

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Measure: Number of patients alive after ICU stay less than 28 days will be tracked

Time: At 28 day

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Description: measuring the long-term impact of confirmed COVID-19 infection. assessment of quality of life according to 8 areas: physical activity (and related limitations), body pain, perception of one's own health, mental health (and related limitations), social life and vitality.

Measure: Short Form 36

Time: at 9 months +/- 3 months after ICU stay

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Description: The scale allows to detect anxiety and depression using 14 items rated from 0-3. Measuring the long-term impact of confirmed COVID-19 infection

Measure: Hospital anxiety and depression scale (HADS)

Time: at 9 months +/- 3 months after ICU stay

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Description: 22-item self-report measure that assesses subjective distress caused by traumatic events Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88) Measuring the long-term impact of confirmed COVID-19 infection

Measure: Impact of Event Scale - revised (IES-R)

Time: at 9 months +/- 3 months after ICU stay

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Description: Question the stressful experience or event, followed by 20 multiple-choice questions. Measuring the long-term impact of confirmed COVID-19 infection

Measure: Post-traumatic stress disorder Checklist version DSM-5 (PSL-5)

Time: at 9 months +/- 3 months after ICU stay

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Description: The mMRC Dyspnea Scale stratifies severity of dyspnea in respiratory diseases Measuring the long-term impact of confirmed COVID-19 infection

Measure: Modified Medical Research Council (MMRC) Dyspnea Scale

Time: at 9 months +/- 3 months after ICU stay

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Measure: Correlation between number of patient deaths and all predictors for Covid-19 including anamnestic, clinical, biological, radiological parameters

Time: until day 28 after admission of ICU

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Description: Evolution of viral clearance in nasal and depp PCR during ICU

Measure: Viral clearance

Time: through study completion, an average of 28 days

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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

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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

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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

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Primary Outcomes

Description: Time (in days) to clinical improvement is defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first within 30 days. The seven-category ordinal scale consisted of the following categories: Not hospitalized with resumption of normal activities Not hospitalized, but unable to resume normal activities Hospitalized, not requiring supplemental oxygen Hospitalized, requiring supplemental oxygen Hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both; Hospitalized, requiring ECMO, invasive mechanical ventilation, or both Death. These parameters will be evaluated daily during hospitalization.

Measure: Time (in days) to clinical improvement within 30 days after randomization

Time: within 30 days

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Secondary Outcomes

Measure: Mortality rate at D30

Time: At day30

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Measure: Time (in days) from randomization to death

Time: up to 30 days after randomization

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Measure: Number of days alive outside ICU within 30 days

Time: At day30

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Measure: Number of days alive free of invasive or non-invasive ventilation within 30 days

Time: At day30

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Measure: Number of days alive with oxygen therapy within 30 days

Time: At day30

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Measure: Maximal oxygen rate within 30 days

Time: At day30

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Measure: Difference between PaO2/FiO2 ratio at randomization and at Day 7 (or at the time of stopping oxygen therapy or discharge if occurs before Day 7)

Time: at Day 7

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Measure: Number of days alive outside hospital within 30 days

Time: at Day 30

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Measure: Use of antibiotics for respiratory (proved or suspected) infection within 30 days

Time: at Day 30

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Measure: Difference between CRP levels at randomization and at Day 7 (or at the time of discharge if occurs before Day 7)

Time: at Day 7

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Measure: Safety outcomes included events that occurred during treatment, serious adverse events, and premature discontinuation of treatment.

Time: up to 30 days after randomization

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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Primary Outcomes

Description: 28-day survival rate, defined by the proportion of patients still alive 28 days after randomization. The 28-day survival rate will be described in each arm of each cohort.

Measure: 28-day survival rate

Time: 28 days from randomization

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Secondary Outcomes

Description: Time to clinical improvement defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale (WHO-ISARIC) or live discharge from the hospital, whichever comes first.

Measure: Time to clinical improvement

Time: 28 days from randomization

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Description: Clinical status will be assessed using a 7-point ordinal scale : 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: Clinical status

Time: Day 7, Day 14, Day 28

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Description: Mean change in clinical status from baseline will be assessed using a 7-point ordinal scale.

Measure: Mean change in clinical status from baseline to days

Time: Day 7, Day 14, Day 28

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Description: Overall survival will be defined by the time from date of randomization until date of death, regardless of the cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.

Measure: Overall survival

Time: 3 months (i.e. at the the time of last patient last visit)

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Description: The length of stay in Intensive Care Unit (from the date of admission in the Unit to the date of discharge).

Measure: Length of stay in Intensive Care Unit

Time: 3 months (i.e. at the the time of last patient last visit)

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Description: The duration of mechanical ventilation or high flow oxygen devices (from the date of intubation to the stop date of mechanical ventilation or high flow oxygen)

Measure: Duration of mechanical ventilation or high flow oxygen devices

Time: 3 months (i.e. at the the time of last patient last visit)

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Description: The duration of hospitalization (from the date of hospitalization to the date of definitive discharge for live patients)

Measure: Duration of hospitalization

Time: 3 months (i.e. at the the time of last patient last visit)

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Measure: Rate of throat swab negativation

Time: Day 7, Day 14, Day 28

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Measure: Quantitative SARS-CoV-2 virus in throat swab and blood samples

Time: Day 7, Day 14, Day 28

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Measure: Rate of secondary infection by other documented pathogens

Time: Day 7, Day 14, Day 28 (if available)

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Description: Changes from baseline in neutrophils count (G/L)

Measure: Biological parameters

Time: 3 months (i.e. at the the time of last patient last visit)

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Description: Treatment-Emergent Adverse Events, Serious Adverse Events, Suspected Unexpected Serious Adverse Reactions, New Safety Issues described using the NCI-CTC AE classification v5. Number of participants with a discontinuation or temporary suspension of study drugs (for any reason).

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

Time: 3 months (i.e. at the the time of last patient last visit)

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Description: Incremental Cost-Effectiveness Ratios (ICERs) expressed in cost per Life Year Gained.

Measure: Cost-Effectiveness Analyses (CEA)

Time: 3 months (i.e. at the the time of last patient last visit)

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Description: Changes from baseline in lymphocytes count (G/L)

Measure: Biological parameters

Time: 3 months (i.e. at the the time of last patient last visit)

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Description: Changes from baseline in platelets count (G/L)

Measure: Biological parameters

Time: 3 months (i.e. at the the time of last patient last visit)

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Description: Changes from baseline in hemoglobin count (g/dL)

Measure: Biological parameters

Time: 3 months (i.e. at the the time of last patient last visit)

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Description: Changes from baseline in CRP count (mg/L)

Measure: Biological parameters

Time: 3 months (i.e. at the the time of last patient last visit)

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Description: Changes from baseline in pro-inflammatory cytokine (IL6)

Measure: Biological parameters

Time: 3 months (i.e. at the the time of last patient last visit)

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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

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Description: Reduction and/or progression of symptomatic days, reduction of symptom severity

Measure: Reduction or Progression of Symptomatic Days

Time: 12 weeks

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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

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Description: Pulse from baseline to 12 weeks

Measure: Assess the safety of Quintuple Therapy via pulse

Time: 12 weeks

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Description: Oxygen saturation from baseline to 12 weeks

Measure: Assess the safety of Quintuple Therapy via oxygen saturation

Time: 12 weeks

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Description: EKG response from baseline to 12 weeks

Measure: Assess the safety of Quintuple Therapy via EKG

Time: 12 weeks

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Description: Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy

Measure: Assess Tolerability of Quintuple Therapy

Time: 12 weeks

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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

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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

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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

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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

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Secondary Outcomes

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: Prevention Study: Measure the effect of NORS on the prevention of progression of COVID- 19

Time: 21 days

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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

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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

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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

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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

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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

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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

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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

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Primary Outcomes

Description: Mortality at day 28

Measure: Mortality at day 28

Time: day 28

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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

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Description: Delay in imaging in hours

Measure: Imaging

Time: day 1

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Description: delay in microbiological diagnosis in hours

Measure: Delay in Microbiological diagnosis

Time: day 1

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Description: Antiviral therapy Yes / no

Measure: Antiviral therapy

Time: up to day 28

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Description: Antibiotic therapy Yes / No

Measure: Antibiotic therapy

Time: day 28

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Description: Covid-19 treatments Yes / No

Measure: Covid-19 treatments

Time: up to day 28

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Description: number

Measure: Patients receiving renal replacement therapy

Time: up to day 28

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Description: number

Measure: Patients receiving mechanical ventilation

Time: up to day 28

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Description: Patient alive at day 28 : yes / No

Measure: Vital status

Time: day 28

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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

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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

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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

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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

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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.

Measure: WHO progression scale ≤ 5

Time: 4 days

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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.

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

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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

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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

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Description: Overall survival.

Measure: Survival

Time: 14, 28 and 90 days

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Measure: 28-day ventilator free-days

Time: 28 days

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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

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Description: Evolution of PaO2/FiO2 ratio.

Measure: PaO2/FiO2 ratio

Time: day 1 to day 14

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Description: Time to oxygen supply independency.

Measure: Time to oxygen supply independency

Time: 14 days

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Description: Duration of hospitalization.

Measure: Duration of hospitalization

Time: 90 days

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Description: Time to negative viral excretion.

Measure: Time to negative viral excretion

Time: 90 days

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Description: Time to ICU discharge.

Measure: Time to ICU discharge

Time: 90 days

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Description: Time to hospital discharge.

Measure: Time to hospital discharge

Time: 90 days

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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

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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

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Primary Outcomes

Measure: Duration of viral shedding

Time: Days 1-14

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Secondary Outcomes

Measure: Duration of COVID-19-attributable symptoms

Time: Everyday through 6 months

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Measure: Hospitalization

Time: within 14 days of enrollment

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Measure: Duration of viral shedding

Time: Days 1-14 and Day 28

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Measure: Adult household contact viral acquisition

Time: Days 1-14 and Day 28

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