Correlated Drug Terms (425)

---

	Name (Synonyms)	Correlation
drug591	Hydroxychloroquine Wiki	0.27
drug1016	Placebo Wiki	0.25
drug1035	Placebo oral tablet Wiki	0.15
drug505	Favipiravir Wiki	0.14
drug1207	Saline Wiki	0.13
drug608	Hydroxychloroquine Sulfate Wiki	0.13
drug763	Losartan Wiki	0.13
drug73	Anakinra Wiki	0.13
drug1504	Zinc Wiki	0.12
drug686	Interferon Beta-1B Wiki	0.12
drug1073	Presatovir Wiki	0.10
drug662	Imatinib Wiki	0.09
drug977	PUL-042 Inhalation Solution Wiki	0.09
drug989	Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances Wiki	0.09
drug596	Hydroxychloroquine + azithromycin Wiki	0.09
drug550	HB-adMSCs Wiki	0.09
drug594	Hydroxychloroquine + Azithromycin Wiki	0.09
drug612	Hydroxychloroquine Sulfate 200 MG Wiki	0.09
drug1076	Probiotic Wiki	0.09
drug1402	Tocilizumab Wiki	0.09
drug1042	Placebos Wiki	0.09
drug1104	Questionnaire Wiki	0.08
drug1475	Vitamin C Wiki	0.08
drug1664	standard therapy Wiki	0.08
drug592	Hydroxychloroquine (HCQ) Wiki	0.08
drug876	Nasopharyngeal swab Wiki	0.08
drug1146	Remdesivir Wiki	0.07
drug1188	SARS-CoV-2 questionnaire survey Wiki	0.07
drug950	Organicell Flow Wiki	0.07
drug636	Hydroxychloroquine, Clindamycin, Primaquine - low dose. Wiki	0.07
drug767	Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki	0.07
drug677	Inhaled Supplemental Oxygen Wiki	0.07
drug969	PLACEBO Wiki	0.07
drug626	Hydroxychloroquine as post exposure prophylaxis Wiki	0.07
drug532	GO2 PEEP MOUTHPIECE Wiki	0.07
drug223	Budesonide dry powder inhaler Wiki	0.07
drug1510	a specifically designed self-administered questionnaire Wiki	0.07
drug1030	Placebo of excipient(s) will be administered Wiki	0.07
drug773	Low-dose chloroquine Wiki	0.07
drug1603	nasal pharyngeal (NP) swab samples Wiki	0.07
drug1354	Tears swab Wiki	0.07
drug150	BM-Allo.MSC Wiki	0.07
drug1326	Surgical facial mask Wiki	0.07
drug1636	prayer Wiki	0.07
drug601	Hydroxychloroquine - Daily dosing Wiki	0.07
drug1154	Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening Wiki	0.07
drug672	Indomethacin Wiki	0.07
drug482	Equipment with smartwatch throughout hospital stay on the general ward Wiki	0.07
drug1400	To assess for development of IgG antibodies against SARS-CoV2 Wiki	0.07
drug649	INC424 / Ruxolitinib Wiki	0.07
drug1136	Recombinant Interferon Alfa-2b Wiki	0.07
drug508	Favipiravir (3200 mg + 1200 mg) combined with Hydroxychloroquine Wiki	0.07
drug1243	Serum SARs COV 2 IGg screening in health care workers Wiki	0.07
drug1645	remdesivir Wiki	0.07
drug219	Bromhexine Hydrochloride Wiki	0.07
drug1533	care modalities Wiki	0.07
drug1125	Ramipril 2.5 MG Oral Capsule Wiki	0.07
drug634	Hydroxychloroquine, Clindamycin Wiki	0.07
drug1236	Seraph®-100 Microbind® Affinity Blood Filter Wiki	0.07
drug14	1: discontinuation of RAS blocker therapy Wiki	0.07
drug898	Nivolumab Injection Wiki	0.07
drug460	Eicosapentaenoic acid gastro-resistant capsules Wiki	0.07
drug362	Convalescent Plasma 1 Unit Wiki	0.07
drug584	Human biological samples Wiki	0.07
drug101	Ascorbic Acid and Zinc Gluconate Wiki	0.07
drug317	Ciclesonide 160Mcg Inhaler Wiki	0.07
drug328	Clinical examination Wiki	0.07
drug1095	Pyridostigmine Bromide Wiki	0.07
drug1119	RT PCR SARS-CoV-2 Wiki	0.07
drug553	HCQ & AZ vs HCQ+SIR Wiki	0.07
drug492	Exercise capacity Wiki	0.07
drug1634	plasma hyperimmune Wiki	0.07
drug1524	bidirectional oxygenation mouthpiece Wiki	0.07
drug1313	Stool collection or fecal swab Wiki	0.07
drug894	Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation Wiki	0.07
drug1029	Placebo of LPV/r Tablets Wiki	0.07
drug1522	bacTRL-Spike Wiki	0.07
drug658	IgM and IgG diagnostic kits to SARS-CoV-2 Wiki	0.07
drug874	Naso pharyngeal swab Wiki	0.07
drug484	Escin Wiki	0.07
drug655	Icosapent ethyl Wiki	0.07
drug1479	Vitamins Wiki	0.07
drug106	Assembled mask Wiki	0.07
drug486	Etoposide Wiki	0.07
drug1653	serum chemistry analysis Wiki	0.07
drug207	Blood sample for whole genome sequencing Wiki	0.07
drug1482	Volatile Organic Compounds analysis Wiki	0.07
drug652	IVERMECTIN (IVER P®) arm will receive IVM 600 µg / kg once daily plus standard care. CONTROL arm will receive standard care. Wiki	0.07
drug554	HCQ + Intravenous Famotidine Wiki	0.07
drug711	Isotonic saline 0.9% Wiki	0.07
drug297	Centricyte 1000 Wiki	0.07
drug1171	Routine standard of care Wiki	0.07
drug755	Lopinavir and Ritonavir Tablets Wiki	0.07
drug512	Favipiravir and Hydroxychloroquine Wiki	0.07
drug615	Hydroxychloroquine Sulfate 400 mg twice a day Wiki	0.07
drug630	Hydroxychloroquine plus standard preventive measures Wiki	0.07
drug3	- Synthetic anti-malarial drugs Wiki	0.07
drug616	Hydroxychloroquine Sulfate 600 mg once a day Wiki	0.07
drug858	NIVOLUMAB Wiki	0.07
drug322	Clazakizumab 12.5 mg Wiki	0.07
drug918	Normobaric oxygen therapy Wiki	0.07
drug560	HOME-CoV rule implementation Wiki	0.07
drug1513	all treatment about COVID-2019 Wiki	0.07
drug578	High-Titer COVID-19 Convalescent Plasma (HT-CCP) Wiki	0.07
drug571	Hidroxicloroquina Wiki	0.07
drug954	Others(No intervention) Wiki	0.07
drug643	Hyperimmune plasma Wiki	0.07
drug1349	Taking biological samples Wiki	0.07
drug927	Observational Study Wiki	0.07
drug766	Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki	0.07
drug493	Exercise physiology Wiki	0.07
drug564	Health-related quality of life Wiki	0.07
drug1680	vaccine BCG Wiki	0.07
drug761	Lopinavir/ritonavir 400 mg/100 mg Wiki	0.07
drug1351	Tap water Wiki	0.07
drug430	Dipyridamole 100 Milligram(mg) Wiki	0.07
drug412	Degarelix Wiki	0.07
drug1613	non-contact magnetically-controlled capsule endoscopy Wiki	0.07
drug286	Capillary and salivary sampling Wiki	0.07
drug1652	serological test Wiki	0.07
drug1385	There is no intervention in this study Wiki	0.07
drug1581	laboratory biomarkers Wiki	0.07
drug188	Biomarkers expression Wiki	0.07
drug483	Ergoferon Wiki	0.07
drug620	Hydroxychloroquine Sulfate Tablets Wiki	0.07
drug1275	Standard Plasma (FFP) Wiki	0.07
drug469	Emtricitabine/tenofovir disoproxil Wiki	0.07
drug632	Hydroxychloroquine sulfate &Azithromycin Wiki	0.07
drug610	Hydroxychloroquine Sulfate + Azithromycin Wiki	0.07
drug1266	Standar of care Wiki	0.07
drug263	COVID-19 positive via testing Wiki	0.07
drug582	Huaier Granule Wiki	0.07
drug647	ID NOW vs. Accula Wiki	0.07
drug1525	biological samples collection Wiki	0.07
drug657	IgG test Wiki	0.07
drug997	Peginterferon lambda alfa-1a subcutaneous injection Wiki	0.07
drug883	Next generation Sequencing (NGS) analysis Wiki	0.07
drug1031	Placebo on a 0- and 14-day schedule Wiki	0.07
drug485	Essential oils Wiki	0.07
drug467	Emapalumab Wiki	0.07
drug443	Drug Isotretinoin (13 cis retinoic acid ) capsules+standard treatment Wiki	0.07
drug1331	Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors Wiki	0.07
drug334	Cohort Wiki	0.07
drug1291	Standard of care treatment Wiki	0.07
drug445	Duodenal biopsy Wiki	0.07
drug605	Hydroxychloroquine Oral Product Wiki	0.07
drug198	Blood collection on admission and longitudinally Wiki	0.07
drug535	Ganovo+ritonavir+/-Interferon nebulization Wiki	0.07
drug1287	Standard of care for SARS-CoV-2 infection Wiki	0.07
drug756	Lopinavir and ritonavir Wiki	0.07
drug1152	ResCure™ Wiki	0.07
drug1574	hyperimmune plasma Wiki	0.07
drug1127	Ranitidine Wiki	0.07
drug393	DAS181 Wiki	0.07
drug771	Low or upper respiratory tract sample Wiki	0.07
drug1484	WHO recommendations (waiting condition) Wiki	0.07
drug395	DAS181 OL Wiki	0.07
drug1686	washed microbiota transplantation Wiki	0.07
drug208	Blood samples Wiki	0.07
drug1377	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	0.07
drug504	Famotidine Wiki	0.07
drug1298	Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin inhalation Wiki	0.07
drug306	Chinese Herbal Medicine Wiki	0.07
drug1074	Presatovir placebo Wiki	0.07
drug1130	Rapid molecular test Wiki	0.07
drug577	High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma Wiki	0.07
drug1032	Placebo on a 0- and 28-day schedule Wiki	0.07
drug809	Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki	0.07
drug290	Carrimycin Wiki	0.07
drug549	HB-adMSC Wiki	0.07
drug1628	phone call Wiki	0.07
drug318	Ciclesonide Inhalation Aerosol Wiki	0.07
drug309	Chloroquine Diphosphate Wiki	0.07
drug98	ArtemiC Wiki	0.07
drug63	Allogeneic NK transfer Wiki	0.07
drug931	Octagam Wiki	0.07
drug875	Nasopharyngeal Swab Wiki	0.07
drug1602	muscle ultrasound Wiki	0.07
drug468	Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet Wiki	0.07
drug523	Fluvoxamine Wiki	0.07
drug617	Hydroxychloroquine Sulfate 600 mg twice a day Wiki	0.07
drug687	Interferon beta 1a Wiki	0.07
drug1036	Placebo plus standard preventive measures Wiki	0.07
drug1159	Ribavirin Wiki	0.07
drug1393	Thrombin Generation Assay (TGA) Wiki	0.07
drug1161	Rintatolimod Wiki	0.07
drug506	Favipiravir (3200 mg + 1200 mg) Wiki	0.07
drug509	Favipiravir (3600 mg + 1600 mg) Wiki	0.07
drug1357	Teleconsultation either by phone or by computer consultation Wiki	0.07
drug1061	Povidone-Iodine 0.5% Wiki	0.07
drug660	Imaging by thoracic scanner Wiki	0.07
drug1191	SARS-CoV-2-test Wiki	0.07
drug1040	Placebo: Emtricitabine/tenofovir disoproxil Placebo Wiki	0.07
drug574	High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki	0.07
drug1395	Thrombomodulin Modified Thrombin Generation Assay (TGA-TM) Wiki	0.07
drug1595	methylprednisolone therapy Wiki	0.07
drug548	Guided online support program Wiki	0.07
drug537	Gargle/Mouthwash Wiki	0.07
drug500	Extra blood sample Wiki	0.07
drug1045	Plasma Donation Wiki	0.07
drug1677	trimethoprim/sulfamethoxazole Wiki	0.07
drug1538	collection of biological samples Wiki	0.07
drug70	Aluminum hydroxide adjuvant (Alhydrogel®) Wiki	0.07
drug808	Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki	0.07
drug530	GLS-1200 Wiki	0.07
drug1569	hydroxychloroquine in combination with camostat mesylate Wiki	0.07
drug176	BioMedomics COVID-19 IgM-IgG Rapid Test Wiki	0.07
drug248	COVID-19 IgM/IgG Rapid Testing, mobile device image capture and telemedicine support Wiki	0.07
drug1514	allogeneic human dental pulp stem cells (BSH BTC & Utooth BTC) Wiki	0.07
drug682	Injection and infusion of LV-SMENP-DC vaccine and antigen-specific CTLs Wiki	0.07
drug100	Ascorbic Acid Wiki	0.07
drug1501	Zanubrutinib Wiki	0.07
drug1293	Standard screening strategy Wiki	0.07
drug641	Hyperbaric oxygen therapy Wiki	0.07
drug311	Chloroquine analog (GNS651) Wiki	0.07
drug575	High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki	0.07
drug624	Hydroxychloroquine and azithromycin treatment Wiki	0.07
drug1642	quetionnary Wiki	0.07
drug651	IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki	0.07
drug627	Hydroxychloroquine combined with Azithromycin Wiki	0.07
drug595	Hydroxychloroquine + Placebo Wiki	0.07
drug1543	convalescent plasma application to SARS-CoV-2 infected patients Wiki	0.07
drug1545	conventional management of patients Wiki	0.07
drug1020	Placebo 250 cc 24 hours continuous infusion for 15 days Wiki	0.07
drug459	Education sessions Wiki	0.07
drug1033	Placebo oral Wiki	0.07
drug707	Intravenous saline injection (Placebo) Wiki	0.07
drug1576	identify SARS-CoV-2 infection by serology Wiki	0.07
drug678	Inhaled beclomethasone Wiki	0.07
drug635	Hydroxychloroquine, Clindamycin, Primaquine - high dose. Wiki	0.07
drug794	Mannitol Wiki	0.07
drug555	HCQ + Placebo Wiki	0.07
drug1570	hydroxychloroquine placebo Wiki	0.07
drug758	Lopinavir/ Ritonavir Oral Tablet Wiki	0.07
drug1506	Zinc Gluconate Wiki	0.07
drug510	Favipiravir + Standard of Care Wiki	0.07
drug1661	standard operating procedures Wiki	0.07
drug1041	Placebo: Hydroxychloroquine Wiki	0.07
drug1299	Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection Wiki	0.07
drug1529	blood samples Wiki	0.07
drug621	Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets Wiki	0.07
drug1508	Zithromax Oral Product Wiki	0.07
drug1481	VivaDiag™ COVID-19 lgM/IgG Rapid Test Wiki	0.07
drug579	High-dose chloroquine Wiki	0.07
drug562	Halo Placebo Wiki	0.07
drug1312	Stool collection Wiki	0.07
drug463	Electric pad for human external pain therapy Wiki	0.07
drug37	ARBOX Wiki	0.07
drug1627	peripheral blood draw Wiki	0.07
drug9	18F-αvβ6-BP Wiki	0.07
drug825	Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki	0.07
drug206	Blood sample for serology to measure past infection with SARS-CoV-2 Wiki	0.07
drug398	Danoprevir+Ritonavir Wiki	0.07
drug1421	Treatment with Dexmedetomidine Wiki	0.07
drug637	Hydroxychloroquine, Doxycycline Wiki	0.07
drug21	2: continuation of RAS blocker therapy Wiki	0.07
drug13	1: Usual practice Wiki	0.07
drug1062	Povidone-Iodine 2% Wiki	0.07
drug1412	Tradipitant Wiki	0.07
drug466	Elisa-test for IgM and IgG to SARS-CoV-2 Wiki	0.07
drug1559	further processing of health data Wiki	0.07
drug722	JNJ-53718678 Wiki	0.07
drug776	Lung Function tests Wiki	0.07
drug1572	hyper immunoglobulins containing anti-Corona VS2 immunoglobulin Wiki	0.07
drug812	Melatonin 2mg Wiki	0.07
drug1358	Telehealth monitoring Wiki	0.07
drug593	Hydroxychloroquine (placebo) Wiki	0.07
drug1163	Risk of MERS infection Wiki	0.07
drug181	Biological samples specific to research Wiki	0.07
drug171	Best Practice Wiki	0.07
drug363	Convalescent Plasma 2 Units Wiki	0.07
drug561	Halo Oral Spray Wiki	0.07
drug941	Only Standard Treatment Wiki	0.07
drug320	Clarithromycin Wiki	0.07
drug1229	Self-guided exercises Wiki	0.07
drug348	Conestat alfa Wiki	0.07
drug418	Desferal 500 MG Injection Wiki	0.07
drug609	Hydroxychloroquine Sulfate (HCQ) Wiki	0.07
drug20	2: Usual practice + SYMBICORT RAPIHALER Wiki	0.07
drug770	Low nitrite/NDMA meals Wiki	0.07
drug606	Hydroxychloroquine Pre-Exposure Prophylaxis Wiki	0.07
drug680	Inhaled nitric oxide gas Wiki	0.07
drug956	Outpatient MRI Wiki	0.07
drug826	Mid-dose chloroquine Wiki	0.07
drug576	High nitrite/NDMA meals Wiki	0.07
drug552	HCQ & AZ Wiki	0.07
drug1520	azithromycin Wiki	0.07
drug1505	Zinc (Placebo) Wiki	0.07
drug1494	Women receiving extra remembering by healthcare Wiki	0.07
drug1361	Telephone follow-up Wiki	0.07
drug507	Favipiravir (3200 mg + 1200 mg) combined with Azithromycin Wiki	0.07
drug1006	Phosphate buffered saline Placebo Wiki	0.07
drug951	Oropharyngeal Swab Wiki	0.07
drug1300	Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection combined with Dalargin inhalation Wiki	0.07
drug1019	Placebo + Placebo Wiki	0.07
drug1587	lung ultrasound (LUS) Wiki	0.07
drug1452	Use of virus (Covid-19) genome sequence report to inform infection prevention control procedures Wiki	0.07
drug798	Matched Placebo Hydroxychloroquine Wiki	0.07
drug628	Hydroxychloroquine in combination of Azithromycin Wiki	0.07
drug191	Biospecimen Collection Wiki	0.07
drug365	Convalescent Plasma from COVID-19 donors Wiki	0.07
drug147	BIOMARKERS IN THE LONG TERM IMPACT OF CORONAVIRUS INFECTION IN THE CARDIORRESPIRATORY SYSTEM Wiki	0.07
drug1583	lopinavir/ritonavir Wiki	0.07
drug491	Exercise brochure Wiki	0.07
drug394	DAS181 COVID-19 Wiki	0.07
drug1310	Sterile Normal Saline for Intravenous Use Wiki	0.07
drug323	Clazakizumab 25 mg Wiki	0.07
drug735	Lactoferrin (Apolactoferrin) Wiki	0.07
drug604	Hydroxychloroquine Only Product in Oral Dose Form Wiki	0.07
drug713	Isotretinoin(Aerosolized 13 cis retinoic acid) +standard treatment Wiki	0.07
drug1012	Physiotherapy Wiki	0.07
drug1245	Serum testing Wiki	0.07
drug368	Convalescent Serum Wiki	0.07
drug1221	Sarilumab Prefilled Syringe Wiki	0.07
drug979	Pacebo: Calcium citrate Wiki	0.07
drug848	N-803 Wiki	0.07
drug494	Experimental drug Wiki	0.07
drug1519	artus Influenza A/B RT-PCR Test Wiki	0.07
drug408	Data research, database analysis Wiki	0.07
drug489	Examine the impact of COVID-19 during pregnancy Wiki	0.07
drug205	Blood sample collection Wiki	0.07
drug1212	Saliva Wiki	0.07
drug1010	Physical exercise Wiki	0.07
drug1107	Questionnaire with precaution information Wiki	0.07
drug1512	additional blood tubes Wiki	0.07
drug661	Imaging of the lungs Wiki	0.07
drug251	COVID-19 Pneumonia Wiki	0.07
drug276	CYNK-001 Wiki	0.07
drug629	Hydroxychloroquine plus Nitazoxanide Wiki	0.07
drug1138	Recombinant S protein SARS vaccine Wiki	0.07
drug644	IC14 Wiki	0.07
drug744	Liberase Enzyme (Roche) Wiki	0.07
drug1123	Radiation therapy Wiki	0.07
drug495	Experimental: Questionnaire without precaution information Wiki	0.07
drug975	PT-Pal Wiki	0.07
drug447	Duvelisib Wiki	0.07
drug202	Blood plasma Wiki	0.07
drug633	Hydroxychloroquine, Azithromycin Wiki	0.07
drug1128	Rapid detection test Wiki	0.07
drug656	Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus Wiki	0.07
drug199	Blood collection on their first consultation and 10 to 14 days later Wiki	0.07
drug410	Defibrotide 25 mg/kg 24 hours continuous infusion for 15 days Wiki	0.07
drug881	New screening strategy Wiki	0.07
drug1392	Throat swab sample for measuring current infection with SARS-CoV-2 Wiki	0.07
drug1195	SARS-Cov2 testing Wiki	0.07
drug428	Dialyzable Leukocyte Extract Wiki	0.07
drug1295	Standard therapy Wiki	0.07
drug1492	Whole Exome Sequencing Wiki	0.07
drug688	Interferon-Alpha2B Wiki	0.07
drug146	BCG-Denmark Wiki	0.07
drug1301	Standard therapy recommended by the Ministry of Health of the Russian Federation. Wiki	0.07
drug1585	lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate Wiki	0.07
drug701	Interview Wiki	0.07
drug1028	Placebo of Hydroxychloroquine Wiki	0.07
drug903	No intervention, observational study Wiki	0.07
drug1280	Standard of Care Wiki	0.06
drug760	Lopinavir/ritonavir Wiki	0.06
drug1278	Standard care Wiki	0.06
drug1476	Vitamin D Wiki	0.06
drug129	Azithromycin Wiki	0.05
drug1650	self-administered questionnaire Wiki	0.05
drug873	Nasal swab Wiki	0.05
drug154	BNT162b1 Wiki	0.05
drug1147	Remdesivir placebo Wiki	0.05
drug1170	Routine care for COVID-19 patients Wiki	0.05
drug897	Nivolumab Wiki	0.05
drug715	Ivermectin Wiki	0.05
drug321	Clazakizumab Wiki	0.05
drug525	Follow up Wiki	0.05
drug15	200 mg EIDD-2801 Wiki	0.05
drug156	BNT162c2 Wiki	0.05
drug551	HCQ Wiki	0.05
drug531	GLS-5300 Wiki	0.05
drug201	Blood draw Wiki	0.05
drug1350	Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling. Wiki	0.05
drug1137	Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Wiki	0.05
drug465	Electronic questionnaire Wiki	0.05
drug401	Data Collection Wiki	0.05
drug618	Hydroxychloroquine Sulfate Loading Dose Wiki	0.05
drug619	Hydroxychloroquine Sulfate Regular dose Wiki	0.05
drug310	Chloroquine Sulfate Wiki	0.05
drug1233	Selinexor Wiki	0.05
drug1240	Serological test Wiki	0.05
drug884	Niclosamide Wiki	0.05
drug314	Chloroquine phosphate Wiki	0.05
drug1248	Siltuximab Wiki	0.05
drug1367	Telmisartan Wiki	0.05
drug1002	Peripheral blood draw Wiki	0.05
drug145	BCG vaccine Wiki	0.05
drug458	Eculizumab Wiki	0.05
drug602	Hydroxychloroquine - Weekly Dosing Wiki	0.05
drug864	NORS (Nitric Oxide Releasing Solution) Wiki	0.05
drug95	Arbidol Wiki	0.05
drug153	BNT162a1 Wiki	0.05
drug1523	basic treatment Wiki	0.05
drug457	Echocardiography Wiki	0.05
drug155	BNT162b2 Wiki	0.05
drug1323	Supportive Care Wiki	0.05
drug900	No intervention Wiki	0.04
drug357	Control group Wiki	0.04
drug613	Hydroxychloroquine Sulfate 200 MG [Plaquenil] Wiki	0.04
drug1359	Telemedicine Wiki	0.04
drug893	Nitric Oxide Wiki	0.04
drug895	Nitric Oxide Gas Wiki	0.04
drug749	Lopinavir / Ritonavir Wiki	0.04
drug1060	Povidone-Iodine Wiki	0.04
drug1567	hydroxychloroquine Wiki	0.04
drug1034	Placebo oral capsule Wiki	0.04
drug1302	Standard treatment Wiki	0.04
drug685	Interferon Beta-1A Wiki	0.04
drug1285	Standard of care Wiki	0.04
drug354	Control Wiki	0.03
drug1453	Usual Care Wiki	0.03
drug1518	anti-SARS-CoV-2 convalescent plasma Wiki	0.03
drug1530	blood sampling Wiki	0.03
drug280	Camostat Mesilate Wiki	0.03
drug1365	Telerehabilitation Wiki	0.03
drug472	Enoxaparin Wiki	0.03
drug952	Oseltamivir Wiki	0.03
drug203	Blood sample Wiki	0.03
drug1220	Sarilumab Wiki	0.03
drug308	Chloroquine Wiki	0.02
drug823	Methylprednisolone Wiki	0.02
drug1631	placebo Wiki	0.02
drug360	Convalescent Plasma Wiki	0.02

Correlated MeSH Terms (74)

---

	Name (Synonyms)	Correlation
D003141	Communicable Diseases NIH	0.66
D045169	Severe Acute Respiratory Syndrome NIH	0.35
D018352	Coronavirus Infections NIH	0.31
D014777	Virus Diseases NIH	0.19
D012141	Respiratory Tract Infections NIH	0.18
D018357	Respiratory Syncytial Virus Infections NIH	0.13
D003333	Coronaviridae Infections NIH	0.13
D012327	RNA Virus Infections NIH	0.13
D029424	Pulmonary Disease, Chronic Obstructive NIH	0.10
D003428	Cross Infection NIH	0.09
D004408	Dysgeusia NIH	0.09
D008173	Lung Diseases, Obstructive NIH	0.08
D009369	Neoplasms, NIH	0.08
D018184	Paramyxoviridae Infections NIH	0.08
D007251	Influenza, Human NIH	0.08
D004066	Digestive System Diseases NIH	0.07
D030341	Nidovirales Infections NIH	0.07
D005767	Gastrointestinal Diseases NIH	0.07
D009362	Neoplasm Metastasis NIH	0.07
D011649	Pulmonary Alveolar Proteinosis NIH	0.07
D009410	Nerve Degeneration NIH	0.07
D001997	Bronchopulmonary Dysplasia NIH	0.07
D008595	Menorrhagia NIH	0.07
D006470	Hemorrhage NIH	0.07
D003384	Coxsackievirus Infections NIH	0.07
D004660	Encephalitis NIH	0.07
D006929	Hyperaldosteronism NIH	0.07
D000075902	Clinical Deterioration NIH	0.07
D014552	Urinary Tract Infections NIH	0.07
D054990	Idiopathic Pulmonary Fibrosis NIH	0.07
D000309	Adrenal Insufficiency NIH	0.07
D054559	Hyperphosphatemia NIH	0.07
D007008	Hypokalemia NIH	0.07
D017250	Caliciviridae Infections NIH	0.07
D011565	Psoriasis NIH	0.07
D055501	Macrophage Activation Syndrome NIH	0.07
D009220	Myositis NIH	0.07
D011014	Pneumonia NIH	0.06
D011024	Pneumonia, Viral NIH	0.06
D008171	Lung Diseases, NIH	0.05
D000857	Olfaction Disorders NIH	0.05
D003139	Common Cold NIH	0.05
D007154	Immune System Diseases NIH	0.05
D006331	Heart Diseases NIH	0.05
D000257	Adenoviridae Infections NIH	0.05
D008175	Lung Neoplasms NIH	0.05
D058070	Asymptomatic Diseases NIH	0.05
D012128	Respiratory Distress Syndrome, Adult NIH	0.04
D012140	Respiratory Tract Diseases NIH	0.04
D055371	Acute Lung Injury NIH	0.04
D012127	Respiratory Distress Syndrome, Newborn NIH	0.04
D011248	Pregnancy Complications NIH	0.04
D007153	Immunologic Deficiency Syndromes NIH	0.04
D007676	Kidney Failure, Chronic NIH	0.04
D003327	Coronary Disease NIH	0.04
D003324	Coronary Artery Disease NIH	0.04
D004211	Disseminated Intravascular Coagulation NIH	0.04
D009205	Myocarditis NIH	0.04
D053120	Respiratory Aspiration NIH	0.03
D020521	Stroke NIH	0.03
D011658	Pulmonary Fibrosis NIH	0.03
D011665	Pulmonary Valve Insufficiency NIH	0.03
D019337	Hematologic Neoplasms NIH	0.03
D004417	Dyspnea NIH	0.03
D020141	Hemostatic Disorders NIH	0.03
D017563	Lung Diseases, Interstitial NIH	0.03
D001778	Blood Coagulation Disorders NIH	0.03
D016638	Critical Illness NIH	0.03
D013577	Syndrome NIH	0.03
D012120	Respiration Disorders NIH	0.02
D006973	Hypertension NIH	0.02
D018450	Disease Progression NIH	0.02
D000860	Hypoxia NIH	0.02
D002318	Cardiovascular Diseases NIH	0.02

Correlated HPO Terms (32)

---

	Name (Synonyms)	Correlation
HP:0011947	Respiratory tract infection HPO	0.17
HP:0002664	Neoplasm HPO	0.08
HP:0006510	Chronic obstructive pulmonary disease HPO	0.08
HP:0000132	Menorrhagia HPO	0.07
HP:0002905	Hyperphosphatemia HPO	0.07
HP:0003765	Psoriasiform dermatitis HPO	0.07
HP:0002900	Hypokalemia HPO	0.07
HP:0002383	Encephalitis HPO	0.07
HP:0100614	Myositis HPO	0.07
HP:0000846	Adrenal insufficiency HPO	0.07
HP:0002180	Neurodegeneration HPO	0.07
HP:0006517	Alveolar proteinosis HPO	0.07
HP:0000859	Hyperaldosteronism HPO	0.07
HP:0006536	Obstructive lung disease HPO	0.06
HP:0002090	Pneumonia HPO	0.06
HP:0002088	Abnormal lung morphology HPO	0.05
HP:0000458	Anosmia HPO	0.05
HP:0012819	Myocarditis HPO	0.05
HP:0011024	Abnormality of the gastrointestinal tract HPO	0.05
HP:0002206	Pulmonary fibrosis HPO	0.04
HP:0001677	Coronary artery atherosclerosis HPO	0.04
HP:0005521	Disseminated intravascular coagulation HPO	0.04
HP:0002721	Immunodeficiency HPO	0.04
HP:0001928	Abnormality of coagulation HPO	0.03
HP:0001297	Stroke HPO	0.03
HP:0010444	Pulmonary insufficiency HPO	0.03
HP:0006515	Interstitial pneumonitis HPO	0.03
HP:0002098	Respiratory distress HPO	0.03
HP:0001909	Leukemia HPO	0.03
HP:0000822	Hypertension HPO	0.03
HP:0012418	Hypoxemia HPO	0.02
HP:0001626	Abnormality of the cardiovascular system HPO	0.02

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.

---

Primary Outcomes

Description: Viral clearance on Day 5 (human influenza) on a throat swab, assessed by RT PCR. Viral clearance on Day 10 (avian influenza) on a throat swab, assessed by RT PCR.

Measure: Viral clearance

Time: 5-10 days

---

Description: • Cmax, Tmax, AUC, apparent volume of distribution, clearance, terminal elimination half-life

Measure: Pharmacokinetics of Oseltamivir

Time: Day 0 and Day 9

---

Secondary Outcomes

Description: Time to viral clearance on a throat swab, assessed by RT PCR. The time to no detectable influenza virus by culture for the throat swab. Change in viral load (log10 copies/mL) over time for all virological samples (lower limit of detection: 1000 copies/mL) Viral susceptibility of cultured influenza virus to antiviral drugs at baseline and post treatment, assessed by genotypical and phenotypical analyses

Measure: Viral end points

Time: 5-10 days

---

Description: Time to fever clearance In hospital mortality and mortality by follow up Time to death Time to trans cutaneous O2 saturation of ≥ 95% on room air Clinical course: pneumothorax, encephalitis/encephalopathy Number of days in hospital Number of days ventilated

Measure: Clinical Efficacy Endpoints

Time: 5-10 days

---

Description: Documented serious adverse events (SAEs) and relationships to oseltamivir AEs leading to drug withdrawal Grade 3 & 4 clinical and laboratory AEs that are probably or definitely related to oseltamivir Skin rashes of any grade Changes in haematological and biochemical parameters over time

Measure: Safety Endpoints

Time: 5-10 days

---

Primary Outcomes

Description: Clinical data collection through case records, and interview of patients or next-of-kin or friend in the event information is unavailable or incompletely documented in the case records. Sample collection will be performed according to the following frequency: First day of enrolment: blood draw (by weight) not more than 20ml, nasal (and/or nasopharyngeal ) and/or throat swab, stool and urine sample. On days 2, 3, 5, 7, 10, 14 and 28: blood (by weight) not more than 10 ml, nasal (and/or nasopharyngeal l) and/or throat swab, stool and urine sample. On D28, blood (by weight) not more than 20ml, will be drawn as most immune response changes manifest by then. If available, urine and stool sample will be collected. If the subject is intubated, endotracheal aspirate will replace nasal and throat swab. Sample collection for research will be done at the same time as samples for clinical testing as far as possible, to minimize patient discomfort.

Measure: Detecting of Novel Pathogens

Time: Day 1 - Day 28 of recruitment

---

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

---

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

---

Measure: Number of Hospitalization-Free Days Following Presatovir Administration

Time: Up to Day 28

---

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

---

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 Nasal Respiratory Syncytial Virus (RSV ) Viral Load From Baseline (Day 1) to Day 9

Time: Baseline; Day 9

---

Description: A Lower Respiratory Tract Complication (LRTC) was defined as one of the below as determined by the adjudication committee: Primary RSV lower respiratory tract infection (LRTI) Secondary bacterial LRTI LRTI due to unusual pathogens Lower respiratory tract complication of unknown etiology

Measure: Percentage of Participants Who Developed a Lower Respiratory Tract Complication

Time: Up to Day 28

---

Secondary Outcomes

Description: Participants were considered to have an event if either condition is met: Participant develops a respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) or; Participant dies prior to or on Day 28

Measure: Percentage of Participants Who Developed Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) or All-cause Mortality

Time: Up to Day 28

---

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

---

Secondary Outcomes

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

Time: Up to Day 28

---

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

Time: Up to Day 28

---

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

Time: Up to Day 28

---

Primary Outcomes

Measure: Freedom from new or progressive chronic lung allograft dysfunction

Time: 180 days

---

Measure: Death

Time: 180 days

---

Secondary Outcomes

Measure: Respiratory virus symptom score

Time: 7 days

---

Measure: Acute rejection

Time: 180 days

---

Measure: Lymphocytic bronchiolitis

Time: 180 days

---

Measure: Donor-specific antibodies

Time: 180 days

---

Measure: Chronic lung allograft dysfunction

Time: 365 days

---

Primary Outcomes

Measure: Numbers of infected patient

Time: Serologic confimred MERS case within 4 weeks after contacting to a case patients

---

Primary Outcomes

Measure: The number of new viruses and/or bacteria identified and characterized by respiratory and pharyngeal carriage among pilgrims between the departure and the return of Hajj

Time: up to 3 years

---

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.

---

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.

---

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.

---

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.

---

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.

---

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.

---

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.

---

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.

---

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.

---

Primary Outcomes

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

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

Time: 26 Days

---

Secondary Outcomes

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

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

Time: Day 5,12,19 and 26

---

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

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

Time: Day 19 and 26

---

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

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

Time: Day 19 and 26

---

Other Outcomes

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

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

Time: Day 26

---

Description: Measured by death from all causes

Measure: Efficacy in reduction of mortality

Time: Day 26

---

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

Measure: Antiviral effect

Time: Day 26

---

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

Measure: Efficacy on clinical improvement

Time: Day 26

---

Description: Measured by change in the Modified Jackson Cold Score

Measure: Efficacy on the respiratory symptoms

Time: Day 26

---

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

---

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

---

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

Time: Day 14

---

Secondary Outcomes

Measure: All-cause mortality rate (main study)

Time: at Day 28

---

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

Time: by Day 21

---

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

Time: Days 10, 14, 21, 28

---

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

Time: by Day 28

---

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

Time: by Days 14, 21, 28 and 35

---

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

Time: through Day 35

---

Measure: Total number of inpatient days (main study)

Time: up to Day 35

---

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

Time: at Day 28

---

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

Time: at Day 35

---

Measure: All-cause mortality rate (main study)

Time: at Day 35

---

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

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

---

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

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

---

Measure: Time to RTRA

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

---

Measure: Time to Clinical stability

Time: Day 14, Day 21, Day 28

---

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

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

---

Measure: Time to Clinical deterioration

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

---

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

Time: Day 14, Day 21, Day 28

---

Measure: Time to Death (all causes)

Time: Day 14, Day 21, Day 28

---

Primary Outcomes

Description: observation of WBCC is correlated with infection by older patient

Measure: Usefulness of white blood cell count (WBCC) during infection in geriatric patient

Time: 1.5 years

---

Primary Outcomes

Description: The proportion of participants who develop RSV LRTI through Visit Day 28 per the Endpoint Adjudication Committee (EAC) assessment will be reported.

Measure: Proportion of Participants who Develop Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI)

Time: Up to Day 28

---

Secondary Outcomes

Description: The proportion of participants who develop RSV-associated LRTC through Visit Day 28 per the EAC's assessment will be reported.

Measure: Proportion of Participants who Develop RSV-associated Lower Respiratory Tract Complication (LRTC)

Time: Up to Day 28

---

Description: An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Measure: Number of Participants with Adverse Events (AEs)

Time: Up to 49 Days

---

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

Measure: Percentage of Participants with Abnormal Clinical Laboratory Findings

Time: Up to 49 days

---

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

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

Time: Up to 49 days

---

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

Measure: Percentage of Participants with Abnormal Vital Signs Findings

Time: Up to 49 days

---

Description: The proportion of participants progressing to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) and/or death, in participants who develop RSV LRTI or RSV-associated LRTC per the EAC's assessment will be reported.

Measure: Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death, in Participants who Develop RSV LRTI or RSV-associated LRTC per the EAC's Assessment

Time: Up to 49 days

---

Description: Proportion of participants progressing to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) and/or death, (all-cause mortality) will be reported.

Measure: Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death, (all-cause Mortality)

Time: Up to 49 days

---

Description: Proportion of participants progressing to death (all-cause mortality), in participants who develop RSV LRTI or RSV-associated LRTC per the EAC's assessment will be reported.

Measure: Proportion of Participants Progressing to Death (All-cause Mortality), in Participants who Develop RSV LRTI or RSV-associated LRTC per the EAC's Assessment

Time: Up to 49 days

---

Description: Proportion of participants progressing to death (all-cause mortality) will be reported.

Measure: Proportion of Participants Progressing to Death (All-cause Mortality)

Time: Up to 49 days

---

Description: Proportion of participants progressing to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive), in participants who develop RSV LRTI or RSV-associated LRTC per the EAC's assessment will be reported.

Measure: Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive), in Participants who Develop RSV LRTI or RSV-associated LRTC per the EAC's Assessment

Time: Up to 49 days

---

Description: Proportion of participants progressing to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) will be reported.

Measure: Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive)

Time: Up to 49 days

---

Description: Number of supplemental O2 free days will be reported.

Measure: Number of Supplemental Oxygen (O2) Free Days Through Day 28

Time: Through Day 28

---

Description: Incidence of supplemental oxygen requirement in participants will be reported.

Measure: Incidence of Supplemental Oxygen Requirement

Time: Up to 28 days

---

Description: Duration of supplemental oxygen requirement in participants will be reported.

Measure: Duration of Supplemental Oxygen

Time: Up to 28 days

---

Description: Change from baseline in respiratory rate as measured by the investigator during scheduled visits will be reported.

Measure: Change from Baseline in Respiratory Rate

Time: Baseline up to 49 days

---

Description: Change from baseline in heart rate as measured by the investigator during scheduled visits will be reported.

Measure: Change from Baseline in Heart Rate

Time: Baseline up to 49 days

---

Description: Change from baseline in SpO2 as measured by the investigator during scheduled visits will be reported.

Measure: Change from Baseline in Peripheral Capillary Oxygen Saturation (SpO2)

Time: Baseline up to 49 days

---

Description: Change from baseline in body temperature as measured by the investigator during scheduled visits will be reported.

Measure: Change from Baseline in Body Temperature

Time: Baseline up to 49 days

---

Description: Proportion of participants hospitalized (of participants who were not hospitalized at baseline) will be reported.

Measure: Proportion of Participants Hospitalized (of Participants who Were not Hospitalized at Baseline)

Time: Up to 49 days

---

Description: Proportion of participants re-hospitalized (of participants who were hospitalized at baseline and discharged during the study and of participants who were not hospitalized at baseline, required hospitalization, and were discharged during the study) will be reported.

Measure: Proportion of Participants Re-hospitalized

Time: Up to 49 days

---

Description: Total length of hospital stay (time in hospital from first dosing) will be reported.

Measure: Total Length of Hospital Stay

Time: Up to 49 days

---

Description: Total time in the ICU (time in ICU from first dosing) will be reported.

Measure: Total Time in the Intensive Care Unit (ICU)

Time: Up to 49 days

---

Description: Incidence of Grade 3 and Grade 4 AEs will be assessed by system organ class where Grade 3: Severe and Grade 4: Life-threatening.

Measure: Incidence of Grade 3 and Grade 4 Adverse Events (AEs)

Time: Up to 49 days

---

Description: Incidence of respiratory AEs will be reported.

Measure: Incidence of Respiratory AEs

Time: Up to 49 days

---

Description: Incidence of thoracic-related AEs will be reported.

Measure: Incidence of Thoracic-related AEs

Time: Up to 49 days

---

Description: Incidence of antibiotic use in participants who develop and in those who do not develop RSV LRTI or RSV-associated LRTC per the EAC's assessment will be reported.

Measure: Incidence of Antibiotic use in Participants who Develop and in Those who do not Develop RSV LRTI or RSV-Associated LRTC per the EAC's Assessment

Time: Up to 49 days

---

Description: Time to resolution of symptoms, assessed through an instrument for participant-reported symptoms (RiiQ Symptom Scale) will be reported.

Measure: Time to Resolution of Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale

Time: Up to 49 days

---

Description: Change from baseline in severity of symptoms reported by participants in the RiiQ symptom scale through Day 28 will be reported.

Measure: Change from Baseline in Severity of Symptoms Reported by Participants in the RiiQ Symptom Scale Through Day 28

Time: Baseline up to Day 28

---

Description: Time to resolution of respiratory illness, through the PGI-S Scale, will be reported.

Measure: Time to Resolution of Respiratory Illness as Assessed by Patient Global Impression of Severity (PGI-S) Scale

Time: Up to 49 days

---

Description: Change from baseline in PGI-H scale through Day 28 will be reported.

Measure: Change from Baseline in Patient Global Impression of Health (PGI-H) Scale Through Day 28

Time: Baseline up to Day 28

---

Description: Change from baseline in PGI-C scale through Day 28 will be reported.

Measure: Change from Baseline in Patient Global Impression of Change (PGI-C) Scale Through Day 28

Time: Baseline up to Day 28

---

Description: AUC (0-24h) is defined as area under the plasma concentration-time curve from time 0 to 24 hours postdose.

Measure: Area Under the Plasma Concentration-time Curve from Time Zero to 24 Hours Postdose (AUC [0-24]) of JNJ-53718678

Time: Up to 24 hours postdose (on Days 1 and 8)

---

Description: Ctrough is defined as the observed plasma concentration before dosing or at the end of the dosing interval.

Measure: Trough Plasma Concentration (Ctrough) of JNJ-53718678

Time: Predose on Days 1 and 8

---

Description: Cmax is defined as the maximum observed plasma concentration of JNJ-53718678 in the dosing interval.

Measure: Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678

Time: Predose; 0.5, 1, 1.5, 2, 4, 8, 24 hours postdose (on Days 1 and 8)

---

Description: The potential association of plasma concentration-time data of JNJ-53718678 with antiviral activity (RSV viral kinetics) will be analyzed. Association will be analyzed using (non)-linear mixed-effects models in a tabular and/or graphical display.

Measure: Association of Plasma Concentration-time Data of JNJ-53718678 and Antiviral Activity

Time: Up to 49 days

---

Description: The potential association of plasma concentration-time data of JNJ-53718678 with selected safety (including AEs and laboratory abnormalities) parameters will be analyzed. Association will be analyzed using (non)-linear mixed-effects models in a tabular and/or graphical display.

Measure: Association of Plasma Concentration-time Data of JNJ-53718678 and Safety Parameters

Time: Up to 49 days

---

Description: The potential association of plasma concentration-time data of JNJ-53718678 with clinical outcomes (proportion of participants developing LRTI) will be analyzed. Association will be analyzed using (non)-linear mixed-effects models in a tabular and/or graphical display.

Measure: Association of Plasma Concentration-time Data of JNJ-53718678 and Clinical Outcomes

Time: Up to 49 days

---

Description: RSV viral load and change from baseline over time will be measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in the mid-turbinate nasal swab specimens.

Measure: RSV Viral Load and Change from Baseline Over Time

Time: Baseline up to Day 28

---

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 8, 11, 15, 22 and 28

Time: Baseline up to Days 8, 11, 15, 22 and 28

---

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 49 days

---

Description: Proportion of participants with undetectable RSV viral load at each time point throughout the study will be reported.

Measure: Proportion of Participants with Undetectable RSV Viral Load at Each Timepoint

Time: Up to 49 days

---

Description: Change from baseline for the HRQOL assessment as assessed through the EQ-5D-5L through Day 28 will be reported.

Measure: Change from Baseline for the Health-related Quality of Life (HRQOL) as Assessed by 5-level EuroQol 5-Dimension (EQ-5D-5L) Through Day 28

Time: Baseline up to Day 28

---

Description: Change from baseline for the HRQOL assessment as assessed through RiiQ impact scales through Day 28 will be reported.

Measure: Change from Baseline for the HRQOL as Assessed by RiiQ Impact Scales Through Day 28

Time: Baseline up to Day 28

---

Description: Change from baseline in the RSV F gene sequence will be reported.

Measure: Change from Baseline in the RSV F Gene Sequence

Time: Baseline up to 49 days

---

Primary Outcomes

Description: Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 16 according to the severity of the condition.

Measure: Lower Murray lung injury score

Time: 7 days after randomization

---

Description: Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 16 according to the severity of the condition.

Measure: Lower Murray lung injury score

Time: 14 days after randomization

---

Secondary Outcomes

Description: PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.

Measure: The difference of PaO2/FiO2 between two groups

Time: 7 days after randomization

---

Description: Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.

Measure: Lower Sequential Organ Failure Assessment (SOFA) score

Time: 7 days after randomization

---

Description: Percentage of patients requiring Mechanical ventilation support

Measure: Mechanical ventilation support

Time: 7 days after randomization

---

Description: PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.

Measure: The difference of PaO2/FiO2 between two groups

Time: 14 days after randomization

---

Description: Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.

Measure: Lower Sequential Organ Failure Assessment (SOFA) score

Time: 14 days after randomization

---

Description: Percentage of patients requiring Mechanical ventilation support

Measure: Mechanical ventilation support

Time: 14 days after randomization

---

Description: Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract

Measure: Clearance of noval coronavirus

Time: 14 days after randomization

---

Description: All-cause mortality

Measure: All-cause mortality

Time: 30 days after randomization

---

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

---

Primary Outcomes

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

Measure: The rate of virus inhibition

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

---

Secondary Outcomes

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

Measure: The disease prorogation-temperature

Time: Day 0 till day 21

---

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

Measure: The disease prorogation-respiratory function 1

Time: Day 0 till day 21

---

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

Measure: The disease prorogation-respiratory function 2

Time: Day 0 till day 21

---

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

Measure: The disease prorogation-respiratory function 3

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

---

Other Outcomes

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

Measure: Patients health condition-routine test

Time: Day 0 till day 21

---

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

Measure: Patients health condition-liver function

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

---

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

Measure: Patients health condition-kidney function

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

---

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

Measure: Patients health condition-other blood routine test

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

---

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

Measure: Patients health condition-blood routine test

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

---

Primary Outcomes

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

Measure: Clinical features

Time: 6 months

---

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

Measure: Response to treatment

Time: 6 months

---

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

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

Time: 6 months

---

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

Measure: Immune host responses to infection and therapy

Time: 6 months

---

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

Measure: Host genetic variants

Time: Day 1

---

Primary Outcomes

Description: Percentage

Measure: The cure rate of 2019-nCoV.

Time: 6 months

---

Description: Percentage

Measure: The improvement rate of 2019-nCoV.

Time: 6 months

---

Measure: The incidence of long-term adverse outcomes.

Time: 6 months

---

Secondary Outcomes

Description: Days

Measure: Duration of fever

Time: 2 weeks

---

Description: Days

Measure: Duration of respiratory symptoms

Time: 2 weeks

---

Description: Days

Measure: Duration of hospitalization

Time: 2 weeks

---

Measure: Number of participant(s) need intensive care

Time: 2 weeks

---

Measure: Number of participant(s) with acute respiratory distress syndrome

Time: 2 weeks

---

Measure: Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al.

Time: 2 weeks

---

Measure: Number of participant(s) who died during the trial

Time: 10 months

---

Primary Outcomes

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

Measure: Time to negative NPS

Time: Up to 1 month

---

Secondary Outcomes

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

Measure: Time to negative saliva

Time: Up to 1 month

---

Description: Time to NEWS of 0

Measure: Time to clinical improvement

Time: Up to 1 month

---

Description: Length of hospitalisation

Measure: Hospitalisation

Time: Up to 1 month

---

Description: 30-day mortality

Measure: Mortality

Time: Up to 1 month

---

Description: Cytokine/ chemokine changes

Measure: Immune reaction

Time: up to 1 month

---

Description: Adverse events during treatment

Measure: Adverse events

Time: up to 1 month

---

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

Measure: Time to negative all clinical specimens

Time: up to 1 month

---

Primary Outcomes

Description: A decline of 2 points on the 7-point scale from admission means better outcome. The 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).

Measure: Clinical improvement based on the 7-point scale

Time: 28 days after randomization

---

Description: Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.

Measure: Lower Murray lung injury score

Time: 7 days after randomization

---

Secondary Outcomes

Description: Number of deaths during study follow-up

Measure: 28-day mortality

Time: Measured from Day 0 through Day 28

---

Description: Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.

Measure: Duration of mechanical ventilation

Time: Measured from Day 0 through Day 28

---

Description: Days that a participant spent at the hospital. Multiple hospitalizations are summed up.

Measure: Duration of hospitalization

Time: Measured from Day 0 through Day 28

---

Description: Proportion of patients with negative RT-PCR results of virus in upper and/or lower respiratory tract samples.

Measure: Proportion of patients with negative RT-PCR results

Time: 7 and 14 days after randomization

---

Description: Proportion of patients in each category of the 7-point scale, the 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).

Measure: Proportion of patients in each category of the 7-point scale

Time: 7,14 and 28 days after randomization

---

Description: Proportion of patients with different inflammation factors in normalization range.

Measure: Proportion of patients with normalized inflammation factors

Time: 7 and 14 days after randomization

---

Description: Frequency of vaccine/CTL Events

Measure: Frequency of vaccine/CTL Events

Time: Measured from Day 0 through Day 28

---

Description: Frequency of Serious vaccine/CTL Events

Measure: Frequency of Serious vaccine/CTL Events

Time: Measured from Day 0 through Day 28

---

Primary Outcomes

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

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

---

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

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: 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.

---

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.

---

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.

---

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.

---

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.

---

Primary Outcomes

Measure: The death of newborns with COVID-19

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

---

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

---

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.

---

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

---

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

---

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

---

Primary Outcomes

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

Measure: Screening accuracy

Time: 1 month

---

Secondary Outcomes

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

Measure: Cost-effectiveness analysis

Time: 1 month

---

Primary Outcomes

Description: Fever to normal time (day)

Measure: Fever to normal time (day)

Time: 30 days

---

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

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

Time: 30 days

---

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

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

Time: 30 days

---

Primary Outcomes

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

Measure: Reduction in the incidence of intubation and mechanical ventilation

Time: 28 days

---

Secondary Outcomes

Description: Mortality from all causes

Measure: Mortality

Time: 28 days

---

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

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

Time: 7 days

---

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

Measure: Time to clinical recovery

Time: 28 days

---

Primary Outcomes

Description: Defined as SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤300mmHg or a respiratory rate ≥30 breaths per min without supplemental oxygen

Measure: Rate of composite adverse outcomes

Time: 14 days

---

Secondary Outcomes

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

Measure: Time to recovery

Time: 14 days

---

Description: Rate of no fever

Measure: Rate of no fever

Time: 14 days

---

Description: Rate of no cough

Measure: Rate of no cough

Time: 14 days

---

Description: Rate of no dyspnea

Measure: Rate of no dyspnea

Time: 14 days

---

Description: Rate of no requiring supplemental oxygen

Measure: Rate of no requiring supplemental oxygen

Time: 14 days

---

Description: Rate of undetectable New coronavirus pathogen nucleic acid

Measure: Rate of undetectable New coronavirus pathogen nucleic acid

Time: 14 days

---

Description: Rate of mechanical ventilation

Measure: Rate of mechanical ventilation

Time: 14 days

---

Description: Rate of ICU admission

Measure: Rate of ICU admission

Time: 14 days

---

Description: Rate of serious adverse event

Measure: Rate of serious adverse event

Time: 14 days

---

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

---

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

---

Primary Outcomes

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

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

Time: 1-6 months

---

Secondary Outcomes

Description: How many patients died during the hospitalization

Measure: in-hospital mortality

Time: 1 month

---

Description: How many patients died 30 days after the discharge

Measure: 30 days mortality

Time: 1 month

---

Description: How many patients died 6 months after the discharge

Measure: 6 months mortality

Time: 6 months

---

Description: How many patients were intubated during the hospitalization

Measure: Intubation rate

Time: 7 days

---

Description: How many days/hours from admittance to intubation

Measure: Time to Intubation

Time: 7 days

---

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

Measure: Time to ventilation

Time: 7 days

---

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

Measure: Non invasive to Invasive time

Time: 7 days

---

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

Measure: Recovery rate

Time: 1 month

---

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

Measure: Recurrence rate

Time: 1 month

---

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

Measure: Risk factor for COVID19

Time: retrospective

---

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

Measure: Blood tests and outcome

Time: 1 month

---

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

Measure: Antiviral therapy

Time: 1 month

---

Description: Assessment of bacterial, fungal or other coinfections rate

Measure: Coinfections

Time: 1 month

---

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

Measure: Radiological findings

Time: 1 month

---

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

Measure: Ultrasound findings

Time: 1 month

---

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

Measure: Myocardial injury

Time: 1 month

---

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

Measure: Medical management

Time: 1 month

---

Primary Outcomes

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

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

Time: 14 days

---

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

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

Time: 14 days

---

Secondary Outcomes

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

Measure: Incidence of Hospitalization

Time: 14 days

---

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

Measure: Incidence of Death

Time: 90 days

---

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

Measure: Incidence of Confirmed SARS-CoV-2 Detection

Time: 14 days

---

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

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

Time: 90 days

---

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

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

Time: 14 days

---

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

Measure: Overall symptom severity at 5 and 14 days

Time: 5 and 14 days

---

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

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

Time: 14 days

---

Primary Outcomes

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

Measure: Hospital Admission

Time: 15 days

---

Secondary Outcomes

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

Measure: Change in PROMIS Dyspnea Functional Limitations

Time: baseline, 10 days

---

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

Measure: Change in PROMIS Dyspnea Severity

Time: baseline, 10 days

---

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

Measure: Daily Maximum Temperature

Time: 10 days

---

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

Measure: Emergency Department/Clinic Presentations

Time: 28 days

---

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

Measure: Disease Severity Rating Day 7

Time: 7 days

---

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

---

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

---

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

Measure: Viral Load by Oropharyngeal Swab Day 9

Time: 9 days

---

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

Measure: Viral Load by Oropharyngeal Swab Day 15

Time: 15 days

---

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

Measure: Ventilator-Free Days

Time: 28 days

---

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

Measure: Therapeutic Oxygen-Free Days

Time: 28 days

---

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

Measure: Need for Hospital Admission at 15 Days

Time: 15 days

---

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

Measure: Need for Oxygen Therapy at 15 Days

Time: 15 days

---

Primary Outcomes

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

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

Time: 7 days

---

Secondary Outcomes

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

Measure: Daily Hypotensive Episodes

Time: 10 days

---

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

Measure: Hypotension Requiring Vasopressors

Time: 10 days

---

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

Measure: Acute Kidney Injury

Time: 10 days

---

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

Measure: Sequential Organ Failure Assessment (SOFA) Total Score

Time: 10 days

---

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

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

Time: 10 days

---

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

Measure: 28-Day Mortality

Time: 28 days

---

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

Measure: 90-Day Mortality

Time: 90 days

---

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

Measure: ICU Admission

Time: 10 days

---

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

Measure: Number of Ventilator-Free Days

Time: 10 days

---

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

Measure: Number of Therapeutic Oxygen-Free Days

Time: 10 days

---

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

Measure: Number of Vasopressor-Free Days

Time: 10 days

---

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

Measure: Length of ICU Stay

Time: 10 days

---

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

Measure: Length of Hospital Stay

Time: 10 days

---

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

Measure: Incidence of Respiratory Failure

Time: 10 days

---

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

---

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

---

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

---

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

Measure: Viral Load by Nasopharyngeal Swab Day 9

Time: 9 days

---

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

Measure: Viral Load by Nasopharyngeal Swab Day 15

Time: 15 days

---

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

Measure: Viral Load by Blood Day 9

Time: 9 days

---

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

Measure: Viral Load by Blood Day 15

Time: 15 days

---

Primary Outcomes

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

Measure: COVID-19 diagnosis

Time: 14 days

---

Secondary Outcomes

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

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

Time: 14 days

---

Other Outcomes

Description: Mean/ Median in the two groups

Measure: Total number of quarantine days

Time: 14 days

---

Description: Percentage in the two groups

Measure: Proportion of healthcare providers requiring quarantine

Time: 14 days

---

Primary Outcomes

Description: To determine the efficacy of PUL-042 Inhalation Solution in decreasing the severity of COVID-19 in subjects: 1) who have documented SARS-CoV-2 infection and, 2) who do not require supplemental oxygen (Ordinal Scale for Clinical Improvement 3 or less) at the time of enrollment. The primary endpoint is the difference in the proportion of patients with clinically meaningful worsening of COVID-19 within 28 days from the start of experimental therapy, as indicated by an increase of at least 2 points on the Ordinal Scale for Clinical Improvement. The Ordinal Scale for Clinical Improvement is a nine point scale (0-8) with 0 being no clinical or virological evidence of infection and 8 being death.

Measure: Severity of COVID-19

Time: 28 days

---

Secondary Outcomes

Description: SARS-Co-V-2 positivity up to 28 days from the start of experimental therapy

Measure: SARS-CoV-2 infection

Time: 28 days

---

Description: To determine the difference in the proportion of COVID-19 patients with clinically meaningful worsening of COVID-19 within 14 days from the start of experimental therapy, as indicated by an increase of at least 2 points on the Ordinal Scale for Clinical Improvement. The Ordinal Scale for Clinical Improvement is a nine point scale (0-8) with 0 being no clinical or virological evidence of infection and 8 being death.

Measure: Severity of COVID-19 over 14 days

Time: 14 days

---

Description: To assess the progression of COVID-19 severity during the study as measured by the SARS-CoV-2 Symptom Score. The SARS-CoV-2 Symptom Score measures 3 elements on a 0-3 scale (cough, shortness of breath or difficulty breathing, and muscle aches or fatigue) ranging from 0 for none to 3 for severe. The fourth element is fever and it is rated on a 0-4 scale with 0 being no fever and 4 being life-threatening.

Measure: Severity of COVID-19 symptoms

Time: 28 days

---

Description: The requirement for ICU admission within 28 days from the start of the experimental therapy.

Measure: ICU admission

Time: 28 days

---

Description: The requirement for mechanical ventilation within 28 days from the start of the experimental therapy.

Measure: Mechanical Ventilation

Time: 28 days

---

Description: All cause mortality at 28 days from the start of experimental therapy

Measure: Mortality

Time: 28 days

---

Primary Outcomes

Description: To determine the efficacy of PUL-042 Inhalation Solution in the prevention of viral infection with SARS-CoV-2 and progression to COVID-19 in subjects: 1) who have repeated exposure to individuals with SARS-CoV-2 infection and, 2) are asymptomatic at enrollment. The primary endpoint is the severity of COVID-19 as measured by the maximum difference from the baseline value in the Ordinal Scale for Symptom Improvement within 28 days from the start of experimental therapy.

Measure: Severity of COVID-19

Time: 28 days

---

Secondary Outcomes

Description: Positive test for SARS-CoV-2 infection 28 days from the start of experimental therapy in subjects who test negative for SARS-CoV-2 at the pre-treatment visit

Measure: Incidence of SARS-CoV-2 infection

Time: 28 days

---

Description: Positive test for SARS-CoV-2 infection 14 days from the start of experimental therapy in subjects who test negative for SARS-CoV-2 at the pre-treatment visit

Measure: Incidence of SARS-CoV-2 infection

Time: 14 days

---

Description: The severity of COVID-19 as measured by the maximum difference from the baseline value in the Ordinal Scale for Symptom Improvement within 14 days from the start of experimental therapy.

Measure: Severity of COVID-19

Time: 14 days

---

Description: The requirement for ICU admission within 28 days from the start of experimental therapy.

Measure: ICU admission

Time: 28 days

---

Description: The requirement for mechanical ventilation within 28 days from the start of experimental therapy.

Measure: Mechanical ventilation

Time: 28 days

---

Description: All cause mortality at 28 days from the start of experimental therapy.

Measure: Mortality

Time: 28 days

---

Primary Outcomes

Description: Viral load assessed by real time polymerase chain reaction in oropharyngeal samples

Measure: Rate of decline in SARS-CoV-2 viral load

Time: Baseline (at randomization) and at 96 hours

---

Secondary Outcomes

Description: National Early Warning Score score determines the degree of illness of a patient. Scores range from 0-20, with a higher score representing further removal from normal physiology and a higher risk of morbidity and mortality.

Measure: Change in National Early Warning Score score

Time: Baseline (at randomization) and at 96 hours

---

Description: Transfer from regular ward to intensive care unit during index admission

Measure: Admission to intensive care unit

Time: At all times after randomization during index admission (between admission and discharge, approximately 21 days)

---

Description: All-cause mortality during index admission

Measure: In-hospital mortality

Time: At all times after randomization during index admission (between admission and discharge, approximately 21 days)

---

Description: Total days admitted to the hospital (difference between admission date and discharge date of index admission)

Measure: Duration of hospital admission

Time: During index admission (between admission and discharge, approximately 21 days)

---

Description: All-cause mortality assessed at 30 and 90 days

Measure: Mortality at 30 and 90 days

Time: At follow-up 30 and 90 days

---

Description: Percentage of subjects reporting each severity rating on a 7-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized, but unable to resume normal activities Not hospitalized, with resumption of normal activities

Measure: Clinical status

Time: 14 days after randomization

---

Description: Change in C-reactive protein concentrations from randomization to 96 hours after randomization

Measure: Change in C-reactive protein concentrations

Time: Baseline (at randomization) and at 96 hours

---

Description: Change in alanine aminotransferase concentrations from randomization to 96 hours after randomization

Measure: Change in alanine aminotransferase concentrations

Time: Baseline (at randomization) and at 96 hours

---

Description: Change in aspartate aminotransferase concentrations from randomization to 96 hours after randomization

Measure: Change in aspartate aminotransferase concentrations

Time: Baseline (at randomization) and at 96 hours

---

Description: Change in bilirubin concentrations from randomization to 96 hours after randomization

Measure: Change in bilirubin concentrations

Time: Baseline (at randomization) and at 96 hours

---

Description: Change in estimated glomerular filtration rate from randomization to 96 hours after randomization

Measure: Change in estimated glomerular filtration rate

Time: Baseline (at randomization) and at 96 hours

---

Description: Change in cardiac troponin concentrations from randomization to 96 hours after randomization

Measure: Change in cardiac troponin concentrations

Time: Baseline (at randomization) and at 96 hours

---

Description: Change in natriuretic peptide concentrations from randomization to 96 hours after randomization

Measure: Change in natriuretic peptide concentrations

Time: Baseline (at randomization) and at 96 hours

---

Primary Outcomes

Description: Number of patients with negative results in the three measurements, compared to the number of patients with at least one positive test

Measure: Number of patients with constant negative results

Time: 30 days

---

Description: Number of patients that present at least one positive VivaDiag test that when subsequently tested with PCR remain positive

Measure: Number of patients with positive test with a positive PCR for COVID-19

Time: 30 days

---

Description: Where available, number of patients positive for COVID-19 IgG and IgM and positive for COVID-19 PCR

Measure: Overall Number of patients positive for COVID-19

Time: six months

---

Description: Where available, number of patients negative for COVID-19 IgG and IgM and negative for COVID-19 PCR

Measure: Overall Number of patients negative for COVID-19

Time: six months

---

Description: Where available, number of patients positive for COVID-19 IgG and IgM and negative for COVID-19 PCR, or negative for COVID-19 IgG and IgM and positive for COVID-19 PCR

Measure: Number of patients with contrasting results

Time: 30 days

---

Secondary Outcomes

Description: Number of Invalid results

Measure: Reliability of the test

Time: 30 days

---

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

Measure: Positive HCW

Time: 60 days

---

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

Measure: Number of Chronic Patients

Time: 60 days

---

Primary Outcomes

Description: The number of pregnant women who have awareness about the disease

Measure: The number of pregnant women who know the exact symptoms of the disease

Time: Within one month

---

Primary Outcomes

Description: Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response

Measure: Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response

Time: Hospital stay (2-3 weeks)

---

Primary Outcomes

Measure: Number of participants who experience inpatient admission

Time: 2 months

---

Secondary Outcomes

Measure: Number of participants admitted to the intensive care unit

Time: 2 months

---

Measure: Number of participants requiring mechanical ventilation

Time: 2 months

---

Measure: Number of deceased participants

Time: 2 months

---

Primary Outcomes

Description: Clinical improvement defined as live hospital discharge OR a 2 point improvement (from time of enrolment) in disease severity rating on the 7-point ordinal scale

Measure: Cohort 1: Days to clinical improvement from study enrolment

Time: 30 days

---

Description: Days to clinical improvement from study enrolment defined no fever for at least 48 hrs AND improvement in other symptoms (e.g. cough, expectoration, myalgia, fatigue, or head ache)

Measure: Cohort 2: Days to clinical improvement from study enrolment

Time: 30 days

---

Secondary Outcomes

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

Time: 30 days

---

Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

Measure: Cohort 1: Clinical status as assessed by the 7-point ordinal scale at day 7, 14 and 30

Time: 30 days

---

Description: Mortality

Measure: Cohort 1: Day 30 mortality

Time: 30 days

---

Description: NEWS2

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

Time: 30 days

---

Description: ICU

Measure: Cohort 1: Admission to ICU

Time: 30 days

---

Description: invasive mechanical ventilation or ECMO

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

Time: 30 days

---

Description: Nasal or high-flow oxygen

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

Time: 30 days

---

Description: Subjective clinical improvement

Measure: Cohort 1+2: Days to self-reported recovery (e.g. limitations in daily life activities) during telephone interviews conducted at day 30

Time: 30 days

---

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

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

Time: 30 days

---

Description: Hospital admission

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

Time: 30 days

---

Primary Outcomes

Description: Evaluation of the clinical status of patients on the 15th day after randomization defined by the Ordinal Scale of 6 points (score ranges from 1 to 6, with 6 being the worst score)

Measure: Evaluation of the clinical status

Time: 15 days after randomization

---

Secondary Outcomes

Description: All-cause mortality rates at 29 days after randomization

Measure: All-cause mortality

Time: 29 days after randomization

---

Description: Evaluation of the clinical status of patients on the 7th and 29th day after randomization defined by the Ordinal Scale of 6 points (score ranges from 1 to 6, with 6 being the worst score)

Measure: Evaluation of the clinical status

Time: 7 and 29 days after randomization

---

Description: Number of days free from mechanical ventilation at 29 days after randomization

Measure: Number of days free from mechanical ventilation

Time: 29 days after randomization

---

Description: Number of days that the patient was on mechanical ventilation after randomization

Measure: Duration of mechanical ventilation

Time: 29 days after randomization

---

Description: Length of hospital stay on survivors

Measure: Duration of hospitalization

Time: 29 days after randomization

---

Description: Presence of other secondary infections

Measure: Other secondary infections

Time: 29 days after randomization

---

Description: Time from treatment start to death

Measure: Time from treatment start to death

Time: 29 days after randomization

---

Description: Morbimortality, daily life activities, mental health, and quality of life

Measure: Medium and long-term outcomes of SARS-CoV2 infection on morbimortality, daily life activities, mental health, and quality of life

Time: 3, 6, 9 and 12 months

---

Description: Leucocyte transcriptome

Measure: Assess whether the tested therapies may be affected by leucocyte phenotype

Time: Baseline

---

Other Outcomes

Description: Occurrence of QT interval prolongation

Measure: QT interval prolongation

Time: 29 days after randomization

---

Description: Occurrence of gastrointestinal intolerance

Measure: Gastrointestinal intolerance

Time: 29 days after randomization

---

Description: Occurrence of laboratory hematimetric parameters, creatinine and bilirubin

Measure: Laboratory abnormalities

Time: 29 days after randomization

---

Description: Occurrence of adverse events related to the use of the investigational products

Measure: Adverse events

Time: 29 days after randomization

---

Primary Outcomes

Description: Evaluation of the clinical status of patients on the 15th day after randomization defined by the Ordinal Scale of 7 points. Alive at home without limitations on activities Alive at home without limitations on activities In the hospital without oxygen In the hospital using oxygen In the hospital using high-flow nasal catheter or non-invasive ventilation In hospital, on mechanical ventilation Dead

Measure: Evaluation of the clinical status

Time: 15 days after randomization

---

Secondary Outcomes

Description: Evaluation of the clinical status of patients on the 7th day after randomization defined by the Ordinal Scale of 7 points. Alive at home without limitations on activities Alive at home without limitations on activities In the hospital without oxygen In the hospital using oxygen In the hospital using high-flow nasal catheter or non-invasive ventilation In hospital, on mechanical ventilation Dead

Measure: Ordinal scale in 7 days

Time: 7 days after randomization

---

Description: Need of intubation and mechanical ventilation up to the 7th day after randomization

Measure: Need of intubation and mechanical ventilation

Time: 7 days after randomization

---

Description: Use of mechanical ventilation during hospital stay

Measure: Use of mechanical ventilation during hospital stay

Time: 15 days after randomization

---

Description: Use of non-invasive ventilation up to the 7th day after randomization

Measure: Use of non-invasive ventilation

Time: 7 days after randomization

---

Description: Hospital Length of Stay

Measure: Hospital Length of Stay

Time: 28 days after randomization

---

Description: All-cause mortality rates during hospital stay

Measure: All-cause mortality

Time: 28 days after randomization

---

Description: Occurrence of thromboembolic complications such as: Deep vein thrombosis Pulmonary Embolism Stroke

Measure: Thromboembolic complications

Time: 15 days after randomization

---

Description: Occurrence of renal dysfunction, defined as an increase in creatinine above 1.5 times the baseline value

Measure: Acute renal disfunction

Time: 15 days after randomization

---

Description: Number of days alive and free of respiratory support up to 15 days (DAFOR15), defined as the sum of days patients did not require supplementary oxygen, non-invasive ventilation, high-flow nasal catheter neither mechanical ventilation at 15 -days. Patients that perished during the 15-day window will receive zero DAFOR15.

Measure: Number of days alive and free of respiratory support up to 15 days

Time: 15 days

---

Other Outcomes

Description: Corrected QT interval

Measure: Safety outcome on corrected QT interval

Time: At day 3 and 7 after enrollment

---

Primary Outcomes

Description: The main objective of this study is to evaluate mortality in siltuximab treated patients and compare the results with the control cohort

Measure: mortality in siltuximab treated patients

Time: 30 days

---

Secondary Outcomes

Description: Assess the need of invasive ventilation in siltuximab patients treated in cohort A and compare the results with the control cohort

Measure: the need of invasive ventilation in siltuximab patients Reduction of the need of time of ventilatory support

Time: 30 days

---

Description: Describe the clinical course of patients treated with siltuximab (Cohort A and B) in terms of ventilatory support and compare the results with the control cohort

Measure: clinical course of patients treated with siltuximab Percentage of patients that undergo to tracheostomy

Time: 30 days

---

Description: Safety of siltuximab treatment

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

Time: 30 days

---

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

Measure: the effect on inflammatory parameters

Time: 30 days

---

Description: Correlation of outcomes with IL-6 levels

Measure: Correlation of outcomes with IL-6 levels

Time: 30 days

---

Primary Outcomes

Description: All cause mortality

Measure: Mortality rate

Time: up to 30 days

---

Description: mild type：no No symptoms, Radiological examination: no pneumonia; possible mild increase in C-reactive portein 2, moderate type: fever, cough, or other respiratory symptoms. Radiological examination: pneumonia, SpO2＞93% without oxygen inhalation ; increase in C reactive protein, 3: severe type: a. Rate ≥30bpm；b. Pulse Oxygen Saturation (SpO2)≤93% without oxygen inhalation，c. PaO2/FiO2(fraction of inspired oxygen )≤300mmHg ；4. Critically type：match any of the follow: a. need mechanical ventilation; b. shock; c. (multiple organ dysfunction syndrome) MODS

Measure: Clinical status evaluated in agreement with guidelines

Time: up to 30 days

---

Secondary Outcomes

Description: Pulse Oxygen Saturation(SpO2)＞93%，1. No need for supplemental oxygenation; 2. nasal catheter oxygen inhalation（oxygen concentration%,The oxygen flow rate：L/min）；3. Mask oxygen inhalation（oxygen concentration%,The oxygen flow rate：L/min）；4. Noninvasive ventilator oxygen supply（Ventilation mode,oxygen concentration%,The oxygen flow rate：L/min,）；5. Invasive ventilator oxygen supply（Ventilation mode,oxygen concentration%,The oxygen flow rate：L/min,）

Measure: The differences in oxygen intake methods

Time: up to 30 days

---

Description: days

Measure: Time of hospitalization (days)

Time: up to 30 days

---

Description: days

Measure: Time of hospitalization in intensive care units

Time: up to 30 days

---

Description: forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge

Measure: Pulmonary function

Time: up to 3 months after discharge

---

Primary Outcomes

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

Time: 14 days

---

Secondary Outcomes

Description: The patient will becategorized into one of the following 8 categories depending on status of their hospitalization: Dead (yes/no) Hospitalized and receiving mechanical ventilation or ExtraCorporalMembraneOxygenation (ECMO) (yes/no) Hospitalized and receiving Non-invasive ventilation or "high-flow oxygen device" (yes/no) Hospitalized and given oxygen supplements different from (2) and (3) (yes/no) Hospitalized and without oxygen treatment, but receiving other treatment (both related to COVID-19 or other) (yes/no) Hospitalized for observation (yes/no) Discharged from hospital with restriction of activity level (yes/no) Discharged from hospital without any restrictions of activity level (yes/no) Only one category can be "yes".

Measure: Categorization of hospitalization status

Time: 14 days

---

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

Time: 14 days

---

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

Time: 14 days

---

Measure: Mortality

Time: 30 days

---

Measure: Length of hospitalization

Time: 14 days

---

Measure: Days alive and discharged from hospital

Time: 30 days

---

Measure: Mortality

Time: 90 days

---

Measure: Mortality

Time: 365 days

---

Measure: Number of readmissions (all causes)

Time: 30 days

---

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

Time: 14 days

---

Description: Delta PaO2 measured in arterial puncture

Measure: Change in patient's oxygen partial pressure

Time: 4 days

---

Description: Delta PaCO2 measured in arterial puncture

Measure: Change in patient's carbondioxid partial pressure

Time: 4 days

---

Description: pH measured in arterial puncture

Measure: Level of pH in blood

Time: 4 days

---

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

Time: 14 days

---

Primary Outcomes

Description: Change in biomarkers (microRNAs, oxidative stress, Neuron-Specific Enolase, IL-2, IL-6, TNF-alfa, leukocytes, subtypes lymphocytes) in covid-19 positive patients vs covid-negative patients

Measure: Biomarkers expression

Time: up to 30 days

---

Description: Change in CYP450 expression in covid-19 positive patients that develop adverse drug reactions or drug inefficacy

Measure: Liver Biomarkers expression

Time: up to 30 days

---

Secondary Outcomes

Description: Changes in biomarkers in covid-19 patients before and after standard treatment

Measure: biomarkers expression (microRNAs, oxidative stress, Neuron-Specific Enolase, IL-2, IL-6, TNF-alfa, leukocytes, subtypes lymphocytes) after treatment

Time: 60 days

---

Primary Outcomes

Description: Defined as the proportion of patients not requiring invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)

Measure: Treatment success

Time: Up to Day 15

---

Secondary Outcomes

Description: Measured in days

Measure: Time to mechanical ventilation

Time: Date of randomization to date of mechanical ventilation

---

Description: Measured in total score

Measure: Change from baseline in Modified Early Warning system score

Time: Baseline, Day 15

---

Description: Measured in percent (%)

Measure: Change from baseline in resting peripheral capillary oxygen saturation (SpO2)

Time: Baseline, 3 assessments every Days 4, 7, 10, 13 and 15

---

Description: Measured in percent (%)

Measure: Change from baseline in partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2)

Time: Baseline, Day 15

---

Description: Measured in local units

Measure: Change of pH in hemogasanalysis from baseline

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Measured in local units

Measure: Change of carbon dioxide tension (pCO2) in hemogasanalysis from baseline

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Measured in local units

Measure: Change of oxygen tension (pO2) in hemogasanalysis from baseline

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Measured in local units

Measure: Change of potassium in hemogasanalysis from baseline

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Measured in local units

Measure: Change of sodium in hemogasanalysis from baseline

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Measured in local units

Measure: Change of chloride in hemogasanalysis from baseline

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Measured in local units

Measure: Change of lactic acid in hemogasanalysis from baseline

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Measured in local units

Measure: Change of hemoglobin in hemogasanalysis from baseline

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Measured in l/min

Measure: Change from baseline in oxygen supplementation

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Measured in scan evaluation: Normal, Abnormal but not clinically significant, Abnormal clinical significant, Not Done

Measure: Change of findings of high-resolution computed tomography (CT) scan of the chest

Time: Screening, Day 15

---

Description: Measured in local units

Measure: Change from baseline in Ferritin

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Measured in local units

Measure: Change from baseline in lactate dehydrogenase (LDH)

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Measured in local units

Measure: Change from baseline in D-dimers

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Measured in local units

Measure: Change from baseline in White Blood Cells with differential counts

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Measured in local units

Measure: Change from baseline in Red Blood Counts

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Measured in local units

Measure: Change from baseline in Hemoglobin

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Measured in local units

Measure: Change from baseline in Platelet count

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Measured in local units

Measure: Change from baseline in Fibrinogen

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Measured in local units

Measure: Change from baseline in Complement factors C3/C4

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Measured in local units

Measure: Change from baseline in Prothrombin time

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Measured in local units

Measure: Change from baseline in Cardiac troponin

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Measured in local units

Measure: Change from baseline in aspartate aminotransferase (AST)

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Measured in local units

Measure: Change from baseline in alanine aminotransferase (ALT)

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Measured in local units

Measure: Change from baseline in total bilirubin levels

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Measured in local units

Measure: Change from baseline in C-Reactive Protein

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Measured in local units

Measure: Change from baseline in Creatinine

Time: Baseline, Days 4, 7, 10, 13 and 15

---

Description: Confirmation of death

Measure: Overall survival

Time: Weeks 6 and 10

---

Description: Measured in days

Measure: Time to hospital discharge

Time: Weeks 6 and 10

---

Primary Outcomes

Measure: Point prevalence of COVID-19 infection

Time: Baseline up to 6 months

---

Secondary Outcomes

Measure: Incidence of COVID-19 infection

Time: Baseline up to 6 months

---

Measure: Percentage of subjects presenting fever or respiratory symptoms

Time: Baseline up to 6 months

---

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

Time: Baseline up to 6 months

---

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

Time: Baseline up to 6 months

---

Primary Outcomes

Description: Reporting of Adverse Events or Severe Adverse Events Assessed by CTCAE v4.0

Measure: Incidence of Treatment-Emergent Adverse Events

Time: 1 month

---

Secondary Outcomes

Description: High Resolution Computerized Tomography of Lung (HRCT Lung) for Fluidda Analysis comparative at baseline and 3 and 6 months post-treatment comparative analytics

Measure: Pulmonary Function Analysis

Time: baseline, 3 Month, 6 months

---

Description: Finger Pulse Oximetry taken before and after 6 minute walk on level ground, compare desaturation tendency

Measure: Digital Oximetry

Time: 3 months, 6 months

---

Primary Outcomes

Description: Size of collected audio dataset measured as number of collected cough sounds, targeting ≥10,000 identified coughs.

Measure: Dataset size

Time: 14 days

---

Secondary Outcomes

Description: Identification of cough sounds by the existing mathematical model with ≥ 99% specificity and ≥ 60% sensitivity

Measure: Cough sound identification

Time: 14 days

---

Description: Increase in the sensitivity of the mathematical model to cough sounds to ≥ 70% while retaining the specificity of ≥ 99%

Measure: Improvement of the existing model

Time: 14 days

---

Description: Determination of the level of acceptance and satisfaction of the solution by patients by means of a Standard Usability Questionnaire to provide feedback. The score ranges from 10 to 50, higher score indicating a better usability.

Measure: Evaluate the usability of the application

Time: 14 days

---

Primary Outcomes

Description: The primary objective of this trial is to investigate whether the use of a cell phone App-based platform is a useful tool to monitor the symptoms of a population in risk of SARS-Cov2 infection. The final aim is to assess determinants of incidence of infection of COVID-19 in people working in Hospital during the pandemia of SARS-Cov-2.

Measure: COVID-19 App-based platform

Time: 6 months

---

Secondary Outcomes

Description: To monitor in real-time COVID-19 symptoms in the hospital workforce, which are a proxy of incident infection (Step 1) To identify in real-time clusters of COVID-19 symptoms and to facilitate control measures. To determine the incidence of new infection of COVID-19. To identify the determinants and risk/protective factors associated with this infection, in a workforce hospital population free of COVID-19 at the start of our study.

Measure: COVID-19 infection

Time: 6 months

---

Primary Outcomes

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

Time: 14 days or discharge

---

Secondary Outcomes

Measure: Treatment and prevention of inflammatory lung injury as measured by change in baseline of interleukin-6 (IL-6)

Time: 14 days or discharge

---

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

Time: 14 days or discharge

---

Measure: In-hospital mortality

Time: 14 days or discharge

---

Measure: Mean change in NEWS2 score from baseline

Time: 14 days or discharge

---

Measure: Understand the effect of genetics for treatment response through whole genome sequence of the participant and the COVID-19 virus

Time: 14 days or discharge

---

Measure: Reduction from baseline of NRS for cough

Time: 14 days or discharge

---

Measure: Reduction from baseline of NRS for nausea

Time: 14 days or discharge

---

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

Time: 14 days or discharge

---

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

Time: 14 days or discharge

---

Primary Outcomes

Description: The primary endpoint for this feasibility study is pulse oximetry level after treatment with a Bidirectional Oxygenation Valve

Measure: Pulse oximetry level

Time: Change from Baseline pulse oximetry level at 15 minutes post treatment

---

Secondary Outcomes

Measure: Respiratory rate

Time: Change from Baseline clinical measurements at 15 minutes post treatment

---

Measure: Heart rate

Time: Change from Baseline clinical measurements at 15 minutes post treatment

---

Measure: Blood pressure

Time: Change from Baseline clinical measurements at 15 minutes post treatment

---

Description: Venous and arterial blood gases, if available, will be combined to report systemic carbon dioxide.

Measure: Systemic carbon dioxide

Time: Change from Baseline clinical measurements at 15 minutes post treatment

---

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

---