Correlated Drug Terms (554)

---

	Name (Synonyms)	Correlation
drug1086	Hydroxychloroquine Wiki	0.26
drug1822	Placebo Wiki	0.22
drug923	Favipiravir Wiki	0.18
drug1853	Placebo oral tablet Wiki	0.15
drug1103	Hydroxychloroquine Sulfate Wiki	0.11
drug1374	Losartan Wiki	0.10
drug1220	Interferon Beta-1B Wiki	0.10
drug2715	Zinc Wiki	0.09
drug159	Anakinra Wiki	0.09
drug1901	Presatovir Wiki	0.08
drug1087	Hydroxychloroquine (HCQ) Wiki	0.08
drug1090	Hydroxychloroquine + azithromycin Wiki	0.08
drug1107	Hydroxychloroquine Sulfate 200 MG Wiki	0.08
drug1381	Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki	0.08
drug1022	HB-adMSCs Wiki	0.08
drug1058	High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki	0.08
drug305	BNT162b2 Wiki	0.08
drug1850	Placebo on a 0- and 28-day schedule Wiki	0.08
drug1178	Imatinib Wiki	0.08
drug2332	Standard of care treatment Wiki	0.08
drug2018	Radiation therapy Wiki	0.08
drug2114	Routine care for COVID-19 patients Wiki	0.08
drug2146	SARS-Cov2 testing Wiki	0.08
drug1089	Hydroxychloroquine + Azithromycin Wiki	0.08
drug1023	HCQ Wiki	0.08
drug1775	Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances Wiki	0.08
drug304	BNT162b1 Wiki	0.08
drug1751	PUL-042 Inhalation Solution Wiki	0.08
drug1115	Hydroxychloroquine Sulfate Tablets Wiki	0.08
drug1458	Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki	0.08
drug576	Clazakizumab Wiki	0.08
drug1613	No intervention Wiki	0.07
drug2662	Vitamin C Wiki	0.07
drug1270	Ivermectin Wiki	0.07
drug2994	self-administered questionnaire Wiki	0.07
drug2620	VPM1002 Wiki	0.07
drug1575	Nasopharyngeal swab Wiki	0.07
drug3012	standard therapy Wiki	0.07
drug2176	Saline Wiki	0.06
drug2663	Vitamin D Wiki	0.06
drug647	Convalescent Plasma Wiki	0.06
drug1978	Questionnaire Wiki	0.06
drug1753	Pacebo: Calcium citrate Wiki	0.06
drug954	Fluoxetine Wiki	0.06
drug1062	High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma Wiki	0.06
drug912	FFP2 Wiki	0.06
drug1326	Lazertinib Wiki	0.06
drug1548	NA-831and Dexamethasone Wiki	0.06
drug2394	Surveys Wiki	0.06
drug947	Fixed Anchoring Strategy Wiki	0.06
drug1158	IP-10 in CDS protocol Wiki	0.06
drug1099	Hydroxychloroquine Only Product in Oral Dose Form Wiki	0.06
drug837	Emapalumab Wiki	0.06
drug2335	Standard screening strategy Wiki	0.06
drug2725	a specifically designed self-administered questionnaire Wiki	0.06
drug1142	IC14 Wiki	0.06
drug2982	rectal swab Wiki	0.06
drug2871	lopinavir/ritonavir Wiki	0.06
drug528	Carrimycin Wiki	0.06
drug2858	intubation Wiki	0.06
drug2802	diagnostic tests for COVID-19 infection Wiki	0.06
drug213	ArtemiC Wiki	0.06
drug945	Fit test Wiki	0.06
drug1387	Low nitrite/NDMA meals Wiki	0.06
drug2856	inhaled type I interferon Wiki	0.06
drug1849	Placebo on a 0- and 14-day schedule Wiki	0.06
drug1378	Low Dose of KBP-COVID-19 Wiki	0.06
drug1035	Halo Placebo Wiki	0.06
drug2794	current IPAC-UHN PPE Wiki	0.06
drug1121	Hydroxychloroquine combined with Azithromycin Wiki	0.06
drug1018	Guided online support program Wiki	0.06
drug1704	Organicell Flow Wiki	0.06
drug1811	Physical Exercises Wiki	0.06
drug2338	Standard therapy Wiki	0.06
drug2490	The demographic, clinical, laboratory, and instrumental data Wiki	0.06
drug2721	Zithromax Oral Product Wiki	0.06
drug1181	Immunfluorescence Wiki	0.06
drug303	BNT162a1 Wiki	0.06
drug2200	Sarilumab Prefilled Syringe Wiki	0.06
drug463	COVID-19 Pneumonia Wiki	0.06
drug293	BIOMARKERS IN THE LONG TERM IMPACT OF CORONAVIRUS INFECTION IN THE CARDIORRESPIRATORY SYSTEM Wiki	0.06
drug1104	Hydroxychloroquine Sulfate (HCQ) Wiki	0.06
drug1110	Hydroxychloroquine Sulfate 400 mg twice a day Wiki	0.06
drug924	Favipiravir (3200 mg + 1200 mg) Wiki	0.06
drug2864	laboratory biomarkers Wiki	0.06
drug927	Favipiravir (3600 mg + 1600 mg) Wiki	0.06
drug2760	biological samples day of delivery Wiki	0.06
drug1063	High-Titer COVID-19 Convalescent Plasma (HT-CCP) Wiki	0.06
drug1433	Maraviroc + Currently used therapy Wiki	0.06
drug474	COVID-19 e-package: Psychological wellbeing for healthcare workers Wiki	0.06
drug728	Data research, database analysis Wiki	0.06
drug2130	SARS-CoV-2 IgG Antibody Testing Kit Wiki	0.06
drug1848	Placebo of excipient(s) will be administered Wiki	0.06
drug1380	Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki	0.06
drug967	Fourth Trimester Mobile Tool Wiki	0.06
drug931	Favipiravir Placebo Wiki	0.06
drug2650	Virtual Assistant first, then Human Coach Wiki	0.06
drug1647	Normobaric oxygen therapy Wiki	0.06
drug1463	Melatonin 2mg Wiki	0.06
drug2946	peripheral blood draw Wiki	0.06
drug2345	Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection Wiki	0.06
drug2460	Telephone follow-up Wiki	0.06
drug764	Dietary Supplement containing resistant starch Wiki	0.06
drug1116	Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets Wiki	0.06
drug2851	identify SARS-CoV-2 infection by serology Wiki	0.06
drug1835	Placebo Sofusbuvir + Daclatasvir Wiki	0.06
drug1851	Placebo oral Wiki	0.06
drug1015	Group1 Wiki	0.06
drug2562	Treatment with Dexmedetomidine Wiki	0.06
drug1340	Liberase Enzyme (Roche) Wiki	0.06
drug1170	IgG antibodies immunoassay Wiki	0.06
drug2515	Thrombomodulin Modified Thrombin Generation Assay (TGA-TM) Wiki	0.06
drug1064	High-flow nasal cannula Wiki	0.06
drug2788	convalescent plasma application to SARS-CoV-2 infected patients Wiki	0.06
drug700	DAS181 OL Wiki	0.06
drug2611	Use of virus (Covid-19) genome sequence report to inform infection prevention control procedures Wiki	0.06
drug982	GX-19 Wiki	0.06
drug653	Convalescent Plasma from COVID-19 donors Wiki	0.06
drug979	GO2 PEEP MOUTHPIECE Wiki	0.06
drug2346	Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection combined with Dalargin inhalation Wiki	0.06
drug526	Caring Contacts Wiki	0.06
drug1272	Ivermectin + Doxycycline Wiki	0.06
drug1139	Hyperimmune plasma Wiki	0.06
drug743	Desferal 500 MG Injection Wiki	0.06
drug32	2: continuation of RAS blocker therapy Wiki	0.06
drug2512	Throat swab sample for measuring current infection with SARS-CoV-2 Wiki	0.06
drug1151	INC424 / Ruxolitinib Wiki	0.06
drug1809	Phsyiotherapy Wiki	0.06
drug1628	Non-Anchoring Strategy Control Wiki	0.06
drug1280	Ivermectin Pill Wiki	0.06
drug2984	remdesivir Wiki	0.06
drug382	Blood sample for whole genome sequencing Wiki	0.06
drug2626	Vancomycin Wiki	0.06
drug247	Auto-questionnaires (patients co infected HIV Sras-CoV-2) Wiki	0.06
drug453	COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support Wiki	0.06
drug1511	Monalizumab Wiki	0.06
drug1431	Manremyc Wiki	0.06
drug1594	Nicotinamide riboside Wiki	0.06
drug296	BM-Allo.MSC Wiki	0.06
drug2350	Standard treatment for COVID-19 Wiki	0.06
drug953	Flow cytometry Wiki	0.06
drug2943	patients COVID 19 Wiki	0.06
drug1211	Inhaled nitric oxide gas Wiki	0.06
drug2243	Serum SARs COV 2 IGg screening in health care workers Wiki	0.06
drug872	Etoposide Wiki	0.06
drug1135	Hyperbaric Oxygen Therapy Wiki	0.06
drug396	Breath Test & Cheek Swab Wiki	0.06
drug613	Combined ART/hydroxychloroquine Wiki	0.06
drug109	Acalabrutinib Treatment B Wiki	0.06
drug345	BioMedomics COVID-19 IgM-IgG Rapid Test Wiki	0.06
drug1185	Immunological profiling Wiki	0.06
drug1221	Interferon beta 1a Wiki	0.06
drug306	BNT162c2 Wiki	0.06
drug2101	Ritonavir Wiki	0.06
drug1123	Hydroxychloroquine plus Nitazoxanide Wiki	0.06
drug712	Danoprevir+Ritonavir Wiki	0.06
drug1275	Ivermectin 3Mg Tab Wiki	0.06
drug240	Atovaquone/Azithromycin Wiki	0.06
drug215	Ascorbic Acid Wiki	0.06
drug3009	standard operating procedures Wiki	0.06
drug1105	Hydroxychloroquine Sulfate + Azithromycin Wiki	0.06
drug1496	Mindfulness + Compassion Intervention (MC) Wiki	0.06
drug1100	Hydroxychloroquine Oral Product Wiki	0.06
drug2870	liposomal lactoferrin Wiki	0.06
drug832	Electric pad for human external pain therapy Wiki	0.06
drug2675	WFI water nebulization Wiki	0.06
drug2017	RUTI® vaccine Wiki	0.06
drug2983	regular care Wiki	0.06
drug1868	Plasma from a volunteer donor Wiki	0.06
drug2299	Standard COVID-19 therapies Wiki	0.06
drug412	Budesonide dry powder inhaler Wiki	0.06
drug2840	hydroxychloroquine Wiki	0.06
drug1014	Group D:Placebo oropharyngeal spray + Placebo taken PO Wiki	0.06
drug1956	Pyridostigmine Bromide Wiki	0.06
drug650	Convalescent Plasma 1 Unit Wiki	0.06
drug1836	Placebo Starch Wiki	0.06
drug2486	The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care: Wiki	0.06
drug628	Conestat alfa Wiki	0.06
drug2894	mobile internet survey on self-test Wiki	0.06
drug350	Biological samples specific to research Wiki	0.06
drug273	BACMUNE (MV130) Wiki	0.06
drug2328	Standard of care for SARS-CoV-2 infection Wiki	0.06
drug2543	Tradipitant Wiki	0.06
drug2718	Zinc Gluconate Wiki	0.06
drug1434	Maraviroc 300 mg Wiki	0.06
drug234	Atazanavir Wiki	0.06
drug2456	Telehealth monitoring Wiki	0.06
drug1031	HOME-CoV rule implementation Wiki	0.06
drug564	Chloroquine analog (GNS651) Wiki	0.06
drug1571	Naso pharyngeal swab Wiki	0.06
drug2308	Standard Plasma (FFP) Wiki	0.06
drug2744	artus Influenza A/B RT-PCR Test Wiki	0.06
drug943	Filtration Test Wiki	0.06
drug1430	Mannitol Wiki	0.06
drug20	1: Usual practice Wiki	0.06
drug1096	Hydroxychloroquine - Daily dosing Wiki	0.06
drug2996	serological test Wiki	0.06
drug14	14C-lazertinib Wiki	0.06
drug1206	Inhaled Supplemental Oxygen Wiki	0.06
drug1137	Hyperbaric oxygen therapy Wiki	0.06
drug3033	tracheostomy Wiki	0.06
drug1051	Hidroxicloroquina Wiki	0.06
drug572	Ciclesonide Inhalation Aerosol Wiki	0.06
drug1799	Personal protective equipment Wiki	0.06
drug2010	RT PCR SARS-CoV-2 Wiki	0.06
drug2694	Whole Exome Sequencing Wiki	0.06
drug1388	Low or upper respiratory tract sample Wiki	0.06
drug1088	Hydroxychloroquine (placebo) Wiki	0.06
drug2997	serology test Wiki	0.06
drug898	Extended sampling and procedures Wiki	0.06
drug1333	Leukapheresis Wiki	0.06
drug1794	Peripheral Blood Wiki	0.06
drug976	GLS-1200 Wiki	0.06
drug31	2: Usual practice + SYMBICORT RAPIHALER Wiki	0.06
drug1408	MFS Wiki	0.06
drug2913	nebulization Wiki	0.06
drug1968	Qualitative interviews (in 40 patients : 20 with COVID-19 and 20 without COVID-19) Wiki	0.06
drug2843	hydroxychloroquine placebo Wiki	0.06
drug2344	Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin inhalation Wiki	0.06
drug2958	prayer Wiki	0.06
drug1371	Lopinavir/Ritonavir 400 mg/100 mg Wiki	0.06
drug2458	Telemedicine follow-up visit Wiki	0.06
drug2903	muscle ultrasound Wiki	0.06
drug1355	Lopinavir / Ritonavir Wiki	0.06
drug21	1: discontinuation of RAS blocker therapy Wiki	0.06
drug1440	Matched Placebo Hydroxychloroquine Wiki	0.06
drug1949	Pulmonary function test Wiki	0.06
drug1025	HCQ & AZ vs HCQ+SIR Wiki	0.06
drug1859	Placebo: Hydroxychloroquine Wiki	0.06
drug1013	Group C:Active principle oropharyngeal spray + Placebo taken PO Wiki	0.06
drug1457	Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki	0.06
drug2923	non-contact magnetically-controlled capsule endoscopy Wiki	0.06
drug1323	Lactoferrin (Apolactoferrin) Wiki	0.06
drug1120	Hydroxychloroquine as post exposure prophylaxis Wiki	0.06
drug1160	IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki	0.06
drug1171	IgG test Wiki	0.06
drug867	Ergoferon Wiki	0.06
drug2873	lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate Wiki	0.06
drug1705	Oropharyngeal Swab Wiki	0.06
drug2077	ResCure™ Wiki	0.06
drug1674	Octagam Wiki	0.06
drug1194	Indomethacin Wiki	0.06
drug1000	Glucose tablets Wiki	0.06
drug1831	Placebo Daclatasvir Wiki	0.06
drug868	Escin Wiki	0.06
drug1161	IVERMECTIN (IVER P®) arm will receive IVM 600 µg / kg once daily plus standard care. CONTROL arm will receive standard care. Wiki	0.06
drug108	Acalabrutinib Treatment A Wiki	0.06
drug3049	washed microbiota transplantation Wiki	0.06
drug1487	Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki	0.06
drug1122	Hydroxychloroquine in combination of Azithromycin Wiki	0.06
drug1883	Povidone-Iodine Wiki	0.06
drug1364	Lopinavir and ritonavir Wiki	0.06
drug2999	serum chemistry analysis Wiki	0.06
drug2699	Women receiving extra remembering by healthcare Wiki	0.06
drug2287	Specimen Collection Wiki	0.06
drug2385	Surgical mask Wiki	0.06
drug2866	lanadelumab Wiki	0.06
drug1053	High Dose of KBP-COVID-19 Wiki	0.06
drug1167	Icosapent ethyl (IPE) Wiki	0.06
drug1407	MEDI7219 Wiki	0.06
drug2730	additional blood tubes Wiki	0.06
drug2027	Rapid detection test Wiki	0.06
drug3039	vaccine BCG Wiki	0.06
drug1286	JNJ-53718678 Wiki	0.06
drug1168	Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus Wiki	0.06
drug921	Famotidine Wiki	0.06
drug648	Convalescent Plasma (CP) Wiki	0.06
drug1547	NA-831 and Atazanavir Wiki	0.06
drug1045	Hemanext One Wiki	0.06
drug1214	Injection and infusion of LV-SMENP-DC vaccine and antigen-specific CTLs Wiki	0.06
drug2666	Vitamins Wiki	0.06
drug1026	HCQ+AZT Wiki	0.06
drug216	Ascorbic Acid and Zinc Gluconate Wiki	0.06
drug2992	saliva sample Wiki	0.06
drug1217	Inspiratory training device Wiki	0.06
drug929	Favipiravir + Standard of Care Wiki	0.06
drug1574	Nasopharyngeal Swab Wiki	0.06
drug1538	N-803 Wiki	0.06
drug763	Dietary Intervention Wiki	0.06
drug3035	trimethoprim/sulfamethoxazole Wiki	0.06
drug1785	Peginterferon lambda alfa-1a subcutaneous injection Wiki	0.06
drug2363	Stimulation test with arginine infusion in order to verify the possible existence of damage to the beta cell function induced by COVID-19 infection Wiki	0.06
drug2772	bronchoscopy examination Wiki	0.06
drug2517	Thymalfasin Wiki	0.06
drug1608	Nitric Oxide-Releasing Drug Wiki	0.06
drug1554	NIVOLUMAB Wiki	0.06
drug932	Favipiravir and Hydroxychloroquine Wiki	0.06
drug1573	Nasopharyngeal (NP) swab Wiki	0.06
drug1858	Placebo: Emtricitabine/tenofovir disoproxil Placebo Wiki	0.06
drug795	Duodenal biopsy Wiki	0.06
drug381	Blood sample for serology to measure past infection with SARS-CoV-2 Wiki	0.06
drug2653	Virtual Group Intervention Wiki	0.06
drug1707	Other Wiki	0.06
drug2365	Stool collection or fecal swab Wiki	0.06
drug2678	WJ-MSCs Wiki	0.06
drug890	Expiratory training device Wiki	0.06
drug689	Curently used therapy for COVID-19 non-critical patients Wiki	0.06
drug2397	Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors Wiki	0.06
drug2245	Serum testing Wiki	0.06
drug1572	NasoVAX Wiki	0.06
drug1560	NO-Immunosuppressive Wiki	0.06
drug988	Ganovo+ritonavir+/-Interferon nebulization Wiki	0.06
drug2842	hydroxychloroquine in combination with camostat mesylate Wiki	0.06
drug1589	New screening strategy Wiki	0.06
drug3	- Synthetic anti-malarial drugs Wiki	0.06
drug1709	Others(No intervention) Wiki	0.06
drug235	Atazanavir and Dexamethasone Wiki	0.06
drug956	Fluvoxamine Wiki	0.06
drug1524	Mucodentol Wiki	0.06
drug2347	Standard therapy recommended by the Ministry of Health of the Russian Federation. Wiki	0.06
drug1079	Human milk donors Wiki	0.06
drug1605	Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation Wiki	0.06
drug1184	Immunoglubulins Wiki	0.06
drug2759	biological samples collection Wiki	0.06
drug1057	High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki	0.06
drug1073	Hospitalized Patients for COVID-19 Infection Wiki	0.06
drug2364	Stool collection Wiki	0.06
drug2224	Sensbiosys Wiki	0.06
drug577	Clazakizumab 12.5 mg Wiki	0.06
drug1060	High nitrite/NDMA meals Wiki	0.06
drug2283	Sofusbuvir + Daclastavir Wiki	0.06
drug1111	Hydroxychloroquine Sulfate 600 mg once a day Wiki	0.06
drug1032	HOPE intervention Wiki	0.06
drug2222	Selitrectinib (BAY2731954) Wiki	0.06
drug2627	Vancomycin with Taper/Pulse Wiki	0.06
drug2384	Surgical facial mask Wiki	0.06
drug986	Gam-COVID-Vac Lyo Wiki	0.06
drug794	Drug: NA-831 Wiki	0.06
drug2489	The control group will not receive hydroxychloroquine Wiki	0.06
drug2947	phone call Wiki	0.06
drug2781	collection of biological samples Wiki	0.06
drug913	FLOW intervention Wiki	0.06
drug1902	Presatovir placebo Wiki	0.06
drug16	18F-αvβ6-BP Wiki	0.06
drug2056	Rehabilitation Wiki	0.06
drug2716	Zinc (Placebo) Wiki	0.06
drug1667	Observational Study Wiki	0.06
drug1354	Lopinavir Wiki	0.06
drug1997	REGN10933+REGN10987 Wiki	0.06
drug578	Clazakizumab 25 mg Wiki	0.06
drug2955	plasma hyperimmune Wiki	0.06
drug784	Doctor Spot Wiki	0.06
drug1301	Knowledge, Attitude, Practice, Awareness, Preference Wiki	0.06
drug1186	Immunosuppressive Wiki	0.06
drug1694	Only Standard Treatment Wiki	0.06
drug1632	Non-contact MCE system Wiki	0.06
drug1177	Imaging of the lungs Wiki	0.06
drug2978	quetionnary Wiki	0.06
drug1435	Maraviroc+Favipiravir+CT Wiki	0.06
drug2099	Risk of MERS infection Wiki	0.06
drug1847	Placebo of LPV/r Tablets Wiki	0.06
drug2296	Standar of care Wiki	0.06
drug1112	Hydroxychloroquine Sulfate 600 mg twice a day Wiki	0.06
drug2186	Saliva Wiki	0.06
drug2845	hyper immunoglobulins containing anti-Corona VS2 immunoglobulin Wiki	0.06
drug2390	Survey Group Wiki	0.06
drug1126	Hydroxychloroquine sulfate &Azithromycin Wiki	0.06
drug1369	Lopinavir/Ritonavir + hydoxychloroquine Wiki	0.06
drug2877	lung ultrasound (LUS) Wiki	0.06
drug2025	Ranitidine Wiki	0.06
drug2494	The standard of care Wiki	0.06
drug1021	HB-adMSC Wiki	0.06
drug990	Gargle/Mouthwash Wiki	0.06
drug2407	T3 solution for injection Wiki	0.06
drug2386	Surgical procedures performed under general anesthesia Wiki	0.06
drug1066	Home Pulse Oximetry Monitoring Wiki	0.06
drug1335	Levamisole Pill + Budesonide+Formoterol inhaler Wiki	0.06
drug1069	Home-based exercise Wiki	0.06
drug2668	VivaDiag™ COVID-19 lgM/IgG Rapid Test Wiki	0.06
drug2889	metenkefalin + tridecactide Wiki	0.06
drug928	Favipiravir + Currently used therapy Wiki	0.06
drug2361	Sterile Normal Saline for Intravenous Use Wiki	0.06
drug1611	Nivolumab Injection Wiki	0.06
drug282	BCG Wiki	0.06
drug505	CYNK-001 Wiki	0.06
drug113	Accuchek Inform II platform Wiki	0.06
drug1711	Outpatient MRI Wiki	0.06
drug1596	Nigella sativa Wiki	0.06
drug2651	Virtual Care and Remote Automated Monitoring Wiki	0.06
drug1289	JNJ-53718678 250 mg Wiki	0.06
drug480	COVID-19 positive via testing Wiki	0.06
drug845	Emtricitabine/tenofovir disoproxil Wiki	0.06
drug1287	JNJ-53718678 125 mg Wiki	0.06
drug347	Biological collection (patients co infected HIV Sras-CoV-2) Wiki	0.06
drug2505	There is no intervention in this study Wiki	0.06
drug1207	Inhaled beclomethasone Wiki	0.06
drug2790	conventional management of patients Wiki	0.06
drug361	Biospecimen Collection Wiki	0.06
drug537	Centricyte 1000 Wiki	0.06
drug1024	HCQ & AZ Wiki	0.06
drug2095	Rintatolimod Wiki	0.06
drug919	Facial mask Wiki	0.06
drug2896	modified IPAC-UHN PPE Wiki	0.06
drug527	Carotid Artery Reactivity Testing Wiki	0.06
drug2750	azithromycin Wiki	0.06
drug651	Convalescent Plasma 2 Units Wiki	0.06
drug253	Avdoralimab Wiki	0.06
drug1797	Personal Exercise Intervention Wiki	0.06
drug985	Gam-COVID-Vac Wiki	0.06
drug2682	Wearing surgical face mask sprayed with hypertonic saline Wiki	0.06
drug1076	Human Coach first, then Virtual Assistant Wiki	0.06
drug575	Clarithromycin Wiki	0.06
drug926	Favipiravir (3200 mg + 1200 mg) combined with Hydroxychloroquine Wiki	0.06
drug1166	Icosapent ethyl Wiki	0.06
drug1169	IgG Wiki	0.06
drug732	Deep Venous Disease Diagnostic Wiki	0.06
drug904	EyeQue Insight Wiki	0.06
drug2038	Recombinant Interferon Alfa-2b Wiki	0.06
drug2956	plasma therapy using convalescent plasma with antibody against SARS-CoV-2 Wiki	0.06
drug1363	Lopinavir and Ritonavir Tablets Wiki	0.06
drug1012	Group B: Placebo oropharyngeal spray + Active principle immunostimulant Wiki	0.06
drug1101	Hydroxychloroquine Pre-Exposure Prophylaxis Wiki	0.06
drug1124	Hydroxychloroquine plus standard preventive measures Wiki	0.06
drug1146	ID NOW vs. Accula Wiki	0.06
drug1591	Next generation Sequencing (NGS) analysis Wiki	0.06
drug1771	Patient Navigation Program Wiki	0.06
drug1910	Probiorinse Wiki	0.06
drug775	Dipyridamole 100 Milligram(mg) Wiki	0.06
drug1550	NG Biotech Wiki	0.06
drug267	Azithromycin 500Mg Oral Tablet Wiki	0.06
drug1074	Huaier Granule Wiki	0.06
drug2676	WHO recommendations (waiting condition) Wiki	0.06
drug1010	Group A: oropharygeal spray and immunostimulant Wiki	0.06
drug2799	decisions of limitations and stop processing Wiki	0.06
drug1034	Halo Oral Spray Wiki	0.06
drug980	GPs reports of potential patient safety incidents, non-COVID-19 related Wiki	0.06
drug406	Bromhexine Hydrochloride Wiki	0.06
drug110	Acalabrutinib Treatment C Wiki	0.06
drug584	Clinical examination Wiki	0.06
drug2316	Standard care therapy Wiki	0.06
drug1497	Mindfulness Alone (MO) Intervention Wiki	0.06
drug2909	nasal pharyngeal (NP) swab samples Wiki	0.06
drug899	Extra blood sample Wiki	0.06
drug1149	IMM-101 Wiki	0.06
drug2891	methylprednisolone therapy Wiki	0.06
drug554	Chest MRI Wiki	0.06
drug1681	Omnibiotic AAD Wiki	0.06
drug2513	Thrombin Generation Assay (TGA) Wiki	0.06
drug761	Dialyzable Leukocyte Extract Wiki	0.06
drug561	Chloroquine Diphosphate Wiki	0.06
drug1077	Human biological samples Wiki	0.06
drug2865	labs Wiki	0.06
drug699	DAS181 COVID-19 Wiki	0.06
drug2525	To assess for development of IgG antibodies against SARS-CoV2 Wiki	0.06
drug2712	Zanubrutinib Wiki	0.06
drug941	FilmArray PCR on respiratory samples Wiki	0.06
drug1846	Placebo of Hydroxychloroquine Wiki	0.06
drug1367	Lopinavir/ Ritonavir Oral Tablet Wiki	0.06
drug2029	Rapid molecular test Wiki	0.06
drug937	Fidaxomicin Wiki	0.06
drug1854	Placebo plus standard preventive measures Wiki	0.06
drug673	CovX Wiki	0.06
drug557	Chinese Herbal Medicine Wiki	0.06
drug1530	Multivitamin Wiki	0.06
drug1176	Imaging by thoracic scanner Wiki	0.06
drug965	Formulation without Active Drug Wiki	0.06
drug221	Assembled mask Wiki	0.06
drug379	Blood sample collection Wiki	0.06
drug1118	Hydroxychloroquine and azithromycin treatment Wiki	0.06
drug1094	Hydroxychloroquine , Sofosbuvir, daclatasvir Wiki	0.06
drug925	Favipiravir (3200 mg + 1200 mg) combined with Azithromycin Wiki	0.06
drug952	Flow controlled ventilation (Evone-ventilator) Wiki	0.06
drug2670	Volatile Organic Compounds analysis Wiki	0.06
drug2323	Standard of Care (SOC) and Colchicine+Rosuvastatin Wiki	0.06
drug1814	Physical exercise Wiki	0.06
drug2756	bidirectional oxygenation mouthpiece Wiki	0.06
drug1133	Hydroxychloroquine/Chloroquine Wiki	0.06
drug600	Cohort Wiki	0.06
drug1190	In-person in clinic follow-up visit Wiki	0.06
drug77	ARBOX Wiki	0.06
drug825	Education sessions Wiki	0.06
drug1829	Placebo Atazanavir Wiki	0.06
drug2152	SCD Wiki	0.06
drug2770	blood test for SARS-COV2 serology Wiki	0.06
drug358	Biomarkers expression Wiki	0.06
drug2115	Routine standard of care Wiki	0.06
drug1801	Personalized Anchoring Strategy Wiki	0.06
drug968	Freestyle Libre 14 day CGM system Wiki	0.06
drug1860	Placebos Wiki	0.05
drug1372	Lopinavir/ritonavir Wiki	0.05
drug2527	Tocilizumab Wiki	0.05
drug2767	blood sampling Wiki	0.05
drug262	Azithromycin Wiki	0.05
drug698	DAS181 Wiki	0.05
drug2319	Standard of Care Wiki	0.04
drug2314	Standard care Wiki	0.04
drug2753	basic treatment Wiki	0.04
drug691	Cyclosporine Wiki	0.04
drug107	Acalabrutinib Wiki	0.04
drug1097	Hydroxychloroquine - Weekly Dosing Wiki	0.04
drug2911	nasopharyngeal swab Wiki	0.04
drug717	Data Collection Wiki	0.04
drug208	Arbidol Wiki	0.04
drug2183	Saline solution Wiki	0.04
drug1269	Itraconazole Wiki	0.04
drug1570	Nasal swab Wiki	0.04
drug374	Blood draw Wiki	0.04
drug960	Follow up Wiki	0.04
drug1642	Normal Saline Wiki	0.04
drug1478	Mesenchymal stromal cells Wiki	0.04
drug1592	Niclosamide Wiki	0.04
drug977	GLS-5300 Wiki	0.04
drug2093	Rifampin Wiki	0.04
drug2221	Selinexor Wiki	0.04
drug335	Best Supportive Care Wiki	0.04
drug821	Echocardiography Wiki	0.04
drug1738	PLACEBO Wiki	0.04
drug1098	Hydroxychloroquine 200 Mg Oral Tablet Wiki	0.04
drug2467	Telmisartan Wiki	0.04
drug563	Chloroquine Sulfate Wiki	0.04
drug24	200 mg EIDD-2801 Wiki	0.04
drug2235	Serological test Wiki	0.04
drug1561	NORS (Nitric Oxide Releasing Solution) Wiki	0.04
drug2267	Sirolimus Wiki	0.04
drug2092	Ribavirin Wiki	0.04
drug824	Eculizumab Wiki	0.04
drug1952	Pulmozyme Wiki	0.04
drug1618	No intervention, observational study Wiki	0.04
drug1660	Observation Wiki	0.04
drug709	Daclatasvir Wiki	0.04
drug892	Exposure Wiki	0.04
drug2121	SAB-185 Wiki	0.04
drug2766	blood samples Wiki	0.04
drug1541	N-acetylcysteine Wiki	0.04
drug377	Blood sample Wiki	0.04
drug1610	Nivolumab Wiki	0.03
drug2134	SARS-CoV-2 convalescent plasma Wiki	0.03
drug285	BCG vaccine Wiki	0.03
drug1911	Probiotic Wiki	0.03
drug2457	Telemedicine Wiki	0.03
drug1108	Hydroxychloroquine Sulfate 200 MG [Plaquenil] Wiki	0.03
drug332	Best Practice Wiki	0.03
drug641	Control group Wiki	0.03
drug1606	Nitric Oxide Gas Wiki	0.03
drug2381	Supportive Care Wiki	0.03
drug603	Colchicine Tablets Wiki	0.03
drug568	Chloroquine phosphate Wiki	0.03
drug1243	Interview Wiki	0.03
drug2067	Remdesivir Wiki	0.03
drug1219	Interferon Beta-1A Wiki	0.03
drug2739	anti-SARS-CoV-2 convalescent plasma Wiki	0.03
drug1604	Nitric Oxide Wiki	0.03
drug2326	Standard of care Wiki	0.03
drug1399	Lung ultrasound Wiki	0.03
drug512	Camostat Mesilate Wiki	0.03
drug2197	Sarilumab Wiki	0.03
drug1645	Normal saline Wiki	0.03
drug1706	Oseltamivir Wiki	0.02
drug2765	blood sample Wiki	0.02
drug2348	Standard treatment Wiki	0.02
drug2915	no intervention Wiki	0.02
drug315	Baricitinib Wiki	0.02
drug1598	Nitazoxanide Wiki	0.02
drug2950	placebo Wiki	0.02

Correlated MeSH Terms (92)

---

	Name (Synonyms)	Correlation
D003141	Communicable Diseases NIH	0.65
D045169	Severe Acute Respiratory Syndrome NIH	0.32
D018352	Coronavirus Infections NIH	0.28
D014777	Virus Diseases NIH	0.18
D012141	Respiratory Tract Infections NIH	0.17
D018357	Respiratory Syncytial Virus Infections NIH	0.12
D003333	Coronaviridae Infections NIH	0.11
D012327	RNA Virus Infections NIH	0.11
D003428	Cross Infection NIH	0.10
D004066	Digestive System Diseases NIH	0.07
D004408	Dysgeusia NIH	0.07
D018184	Paramyxoviridae Infections NIH	0.07
D005767	Gastrointestinal Diseases NIH	0.07
D029424	Pulmonary Disease, Chronic Obstructive NIH	0.06
D030341	Nidovirales Infections NIH	0.06
D001997	Bronchopulmonary Dysplasia NIH	0.06
D008595	Menorrhagia NIH	0.06
D006929	Hyperaldosteronism NIH	0.06
D014552	Urinary Tract Infections NIH	0.06
D054559	Hyperphosphatemia NIH	0.06
D028361	Mitochondrial Diseases NIH	0.06
D004314	Down Syndrome NIH	0.06
D011565	Psoriasis NIH	0.06
D009220	Myositis NIH	0.06
D021821	Communicable Diseases, Emerging NIH	0.06
D058345	Asymptomatic Infections NIH	0.06
D011649	Pulmonary Alveolar Proteinosis NIH	0.06
D009410	Nerve Degeneration NIH	0.06
D006331	Heart Diseases NIH	0.06
D063806	Myalgia NIH	0.06
D008173	Lung Diseases, Obstructive NIH	0.06
D003384	Coxsackievirus Infections NIH	0.06
D004660	Encephalitis NIH	0.06
D054990	Idiopathic Pulmonary Fibrosis NIH	0.06
D000309	Adrenal Insufficiency NIH	0.06
D007008	Hypokalemia NIH	0.06
D055501	Macrophage Activation Syndrome NIH	0.06
D011014	Pneumonia NIH	0.05
D007251	Influenza, Human NIH	0.05
D009369	Neoplasms, NIH	0.05
D011024	Pneumonia, Viral NIH	0.05
D004417	Dyspnea NIH	0.04
D012140	Respiratory Tract Diseases NIH	0.04
D009080	Mucocutaneous Lymph Node Syndrome NIH	0.04
D000075902	Clinical Deterioration NIH	0.04
D058070	Asymptomatic Diseases NIH	0.04
D003139	Common Cold NIH	0.04
D000257	Adenoviridae Infections NIH	0.04
D006470	Hemorrhage NIH	0.04
D017250	Caliciviridae Infections NIH	0.04
D012128	Respiratory Distress Syndrome, Adult NIH	0.03
D020141	Hemostatic Disorders NIH	0.03
D001778	Blood Coagulation Disorders NIH	0.03
D055371	Acute Lung Injury NIH	0.03
D012127	Respiratory Distress Syndrome, Newborn NIH	0.03
D000857	Olfaction Disorders NIH	0.03
D000163	Acquired Immunodeficiency Syndrome NIH	0.03
D012120	Respiration Disorders NIH	0.03
D009362	Neoplasm Metastasis NIH	0.03
D008171	Lung Diseases, NIH	0.03
D018450	Disease Progression NIH	0.03
D004211	Disseminated Intravascular Coagulation NIH	0.03
D009164	Mycobacterium Infections NIH	0.03
D001289	Attention Deficit Disorder with Hyperactivity NIH	0.03
D003327	Coronary Disease NIH	0.03
D003324	Coronary Artery Disease NIH	0.03
D008175	Lung Neoplasms NIH	0.03
D015535	Arthritis, Psoriatic NIH	0.03
D004198	Disease Susceptibility NIH	0.03
D011658	Pulmonary Fibrosis NIH	0.03
D013577	Syndrome NIH	0.03
D015658	HIV Infections NIH	0.02
D011248	Pregnancy Complications NIH	0.02
D007153	Immunologic Deficiency Syndromes NIH	0.02
D007154	Immune System Diseases NIH	0.02
D011665	Pulmonary Valve Insufficiency NIH	0.02
D007676	Kidney Failure, Chronic NIH	0.02
D004630	Emergencies NIH	0.02
D000066553	Problem Behavior NIH	0.02
D053120	Respiratory Aspiration NIH	0.02
D019337	Hematologic Neoplasms NIH	0.02
D001172	Arthritis, Rheumatoid NIH	0.02
D009205	Myocarditis NIH	0.02
D017563	Lung Diseases, Interstitial NIH	0.02
D020521	Stroke NIH	0.02
D001168	Arthritis NIH	0.02
D016638	Critical Illness NIH	0.02
D006973	Hypertension NIH	0.02
D000860	Hypoxia NIH	0.01
D002318	Cardiovascular Diseases NIH	0.01
D055370	Lung Injury NIH	0.01
D004194	Disease NIH	0.01

Correlated HPO Terms (38)

---

	Name (Synonyms)	Correlation
HP:0011947	Respiratory tract infection HPO	0.17
HP:0006510	Chronic pulmonary obstruction HPO	0.06
HP:0002905	Hyperphosphatemia HPO	0.06
HP:0003765	Psoriasiform dermatitis HPO	0.06
HP:0002900	Hypokalemia HPO	0.06
HP:0000846	Adrenal insufficiency HPO	0.06
HP:0000132	Menorrhagia HPO	0.06
HP:0006536	Pulmonary obstruction HPO	0.06
HP:0003326	Myalgia HPO	0.06
HP:0002383	Encephalitis HPO	0.06
HP:0100614	Myositis HPO	0.06
HP:0002180	Neurodegeneration HPO	0.06
HP:0006517	Intraalveolar phospholipid accumulation HPO	0.06
HP:0000859	Hyperaldosteronism HPO	0.06
HP:0002090	Pneumonia HPO	0.05
HP:0002664	Neoplasm HPO	0.05
HP:0011024	Abnormality of the gastrointestinal tract HPO	0.05
HP:0002098	Respiratory distress HPO	0.04
HP:0001928	Abnormality of coagulation HPO	0.03
HP:0000458	Anosmia HPO	0.03
HP:0002088	Abnormal lung morphology HPO	0.03
HP:0001677	Coronary artery atherosclerosis HPO	0.03
HP:0005521	Disseminated intravascular coagulation HPO	0.03
HP:0007018	Attention deficit hyperactivity disorder HPO	0.03
HP:0100526	Neoplasm of the lung HPO	0.03
HP:0002206	Pulmonary fibrosis HPO	0.03
HP:0002721	Immunodeficiency HPO	0.02
HP:0010444	Pulmonary insufficiency HPO	0.02
HP:0001370	Rheumatoid arthritis HPO	0.02
HP:0012819	Myocarditis HPO	0.02
HP:0000708	Behavioral abnormality HPO	0.02
HP:0006515	Interstitial pneumonitis HPO	0.02
HP:0001297	Stroke HPO	0.02
HP:0001369	Arthritis HPO	0.02
HP:0000822	Hypertension HPO	0.02
HP:0001909	Leukemia HPO	0.02
HP:0012418	Hypoxemia HPO	0.01
HP:0001626	Abnormality of the cardiovascular system HPO	0.01

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: January 2031

Measure: Sample collection, analysis of immune function, or review of tissue bx or clinical rpts from outside labs in designated pop. w/ viral, suspected, or recovered from a viral infection or a close contact of people w/or suspected to have a viral inf...

Time: open-ended

---

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

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

Time: Baseline through Day 5

---

Secondary Outcomes

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

Measure: RSV Viral Load and Change from Baseline Over Time

Time: Baseline through Day 21

---

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

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

Time: Baseline through Days 3, 8 and 14

---

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

Measure: Time to Undetectable RSV Viral Load

Time: Up to 21 days

---

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

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

Time: Up to 21 days

---

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

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

Time: Up to 21 days

---

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

Measure: Severity of RSV Disease Assessed by PRESORS

Time: Up to 21 days

---

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

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

Time: Baseline up to 21 days

---

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

Measure: Change from Baseline in Clinician PRESORS Scores

Time: Baseline up to 21 days

---

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

Measure: Time to Resolution of RSV Symptoms

Time: Up to 21 days

---

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

Measure: Time to Improvement on Overall Health

Time: Up to 21 days

---

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

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

Time: Up to 21 days

---

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

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

Time: Up to 21 days

---

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

Measure: Proportion of Participants with Vital Sign Abnormalities

Time: Up to 28 days

---

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

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

Time: Up to 28 days

---

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

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

Time: Up to 21 days

---

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

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

Time: Up to 21 days

---

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

Measure: Cohort 1: Time to Discharge

Time: Up to 21 days

---

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

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

Time: Up to 21 days

---

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

Measure: Cohort 1: Duration of ICU Stay

Time: Up to 21 days

---

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

Measure: Cohort 1: Proportion Participants who Require Supplemental Oxygen

Time: Up to 21 days

---

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

Measure: Cohort 1: Duration of Supplemental Oxygen

Time: Up to 21 days

---

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

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

Time: Up to 21 days

---

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

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

Time: Up to 21 days

---

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

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

Time: Up to 21 days

---

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

Measure: Cohort 1: Duration of Invasive Ventilator Support

Time: Up to 21 days

---

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

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

Time: Up to 21 days

---

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

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

Time: Up to 21 days

---

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

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

Time: Up to 21 days

---

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

Measure: Percentage of Participants with Adverse Events

Time: Up to 28 days

---

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

Measure: Percentage of Participants with Abnormal Laboratory Findings

Time: Up to 28 days

---

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

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

Time: Up to 21 days

---

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

Measure: Plasma Concentrations of JNJ-53718678

Time: Days 1 and 3

---

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

Measure: Medical Resource Utilization

Time: Up to 28 days

---

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

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

Time: Day 8

---

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

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

Time: Up to 21 days

---

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: Species count in fecal sample

Measure: Gut microbiome species richness

Time: 1 Day

---

Description: Measurement of blood lipids

Measure: Lipids

Time: 3 days

---

Description: Measurement of blood glucose

Measure: Glucose

Time: 11 days

---

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

Measure: Sleep

Time: 10 days

---

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

Measure: Physical activity

Time: 10 days

---

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

Measure: Hunger and appetite assessment

Time: 10 days

---

Secondary Outcomes

Description: C-peptide

Measure: Glucose metabolism

Time: 3 days

---

Description: Weighed food log

Measure: Dietary assessment

Time: 10 days

---

Description: Weight (kg)

Measure: Anthropometry

Time: 1 day

---

Description: Height (cm)

Measure: Anthropometry

Time: 1 day

---

Description: Hip and waist circumference (cm)

Measure: Anthropometry

Time: 1 day

---

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

Measure: Metabolomics by NMR analysis

Time: 1 day

---

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

Measure: Dietary assessment

Time: 1 month

---

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

Measure: Covid-19 symptom assessment

Time: 6 months

---

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 1 year

---

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 1 year

---

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 1 year

---

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: Day 1

---

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 4 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 4 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: after the end of this study, investigators calculate and sum up the total evaluated population and positively diagnosed population, then check the ROC of this system, finally to calculate the sensitivity and accuracy of this self-test and self-alert system

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

Time: 5 months

---

Secondary Outcomes

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

Measure: distribution map of evaluated people

Time: 5 month

---

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

Measure: Effect of medical guidance by designated feedback questionnaire

Time: 5 month

---

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

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

Time: 5 month

---

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

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Primary Outcomes

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Primary Outcomes

Measure: The death of newborns with COVID-19

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

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

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

Time: within 7days after the admission

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Secondary Outcomes

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

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

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

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

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

Time: at birth

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

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

Time: at birth

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

Measure: The disease severity of neonates with COVID-19

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

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Primary Outcomes

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

Measure: Screening accuracy

Time: 1 month

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Secondary Outcomes

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

Measure: Cost-effectiveness analysis

Time: 1 month

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Primary Outcomes

Description: Fever to normal time (day)

Measure: Fever to normal time (day)

Time: 30 days

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

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

Time: 30 days

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

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

Time: 30 days

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Primary Outcomes

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

Measure: Reduction in the incidence of intubation and mechanical ventilation

Time: 28 days

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Secondary Outcomes

Description: Mortality from all causes

Measure: Mortality

Time: 28 days

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

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

Time: 7 days

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

Measure: Time to clinical recovery

Time: 28 days

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Primary Outcomes

Description: 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

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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

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Description: Rate of no fever

Measure: Rate of no fever

Time: 14 days

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Description: Rate of no cough

Measure: Rate of no cough

Time: 14 days

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Description: Rate of no dyspnea

Measure: Rate of no dyspnea

Time: 14 days

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Description: Rate of no requiring supplemental oxygen

Measure: Rate of no requiring supplemental oxygen

Time: 14 days

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Description: Rate of undetectable New coronavirus pathogen nucleic acid

Measure: Rate of undetectable New coronavirus pathogen nucleic acid

Time: 14 days

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Description: Rate of mechanical ventilation

Measure: Rate of mechanical ventilation

Time: 14 days

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Description: Rate of ICU admission

Measure: Rate of ICU admission

Time: 14 days

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Description: Rate of serious adverse event

Measure: Rate of serious adverse event

Time: 14 days

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Primary Outcomes

Description: Percent of subjects who have returned to room air

Measure: Percent of subjects who have returned to room air

Time: 7 days

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

Measure: Percent change of subjects return to baseline oxygen requirement

Time: 7 days

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Primary Outcomes

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

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

Time: 3 months

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Secondary Outcomes

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

Measure: Identification of risk factors for seroconversion

Time: 3 months

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

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

Time: 3 months

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

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

Time: 3 months

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Primary Outcomes

Description: 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

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Secondary Outcomes

Description: How many patients died during the hospitalization

Measure: in-hospital mortality

Time: 1 month

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Description: How many patients died 30 days after the discharge

Measure: 30 days mortality

Time: 1 month

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Description: How many patients died 6 months after the discharge

Measure: 6 months mortality

Time: 6 months

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Description: How many patients were intubated during the hospitalization

Measure: Intubation rate

Time: 7 days

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Description: How many days/hours from admittance to intubation

Measure: Time to Intubation

Time: 7 days

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

Measure: Time to ventilation

Time: 7 days

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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

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

Measure: Recovery rate

Time: 1 month

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

Measure: Recurrence rate

Time: 1 month

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

Measure: Risk factor for COVID19

Time: retrospective

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

Measure: Blood tests and outcome

Time: 1 month

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

Measure: Antiviral therapy

Time: 1 month

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Description: Assessment of bacterial, fungal or other coinfections rate

Measure: Coinfections

Time: 1 month

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

Measure: Radiological findings

Time: 1 month

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

Measure: Ultrasound findings

Time: 1 month

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

Measure: Myocardial injury

Time: 1 month

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

Measure: Medical management

Time: 1 month

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Primary Outcomes

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

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

Time: 14 days

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

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

Time: 14 days

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Secondary Outcomes

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

Measure: Incidence of Hospitalization

Time: 14 days

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

Measure: Incidence of Death

Time: 90 days

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

Measure: Incidence of Confirmed SARS-CoV-2 Detection

Time: 14 days

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

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

Time: 90 days

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

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

Time: 14 days

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

Measure: Overall symptom severity at 5 and 14 days

Time: 5 and 14 days

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

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

Time: 14 days

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Primary Outcomes

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

Measure: Hospital Admission

Time: 15 days

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Secondary Outcomes

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

Measure: Change in PROMIS Dyspnea Functional Limitations

Time: baseline, 10 days

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

Measure: Change in PROMIS Dyspnea Severity

Time: baseline, 10 days

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

Measure: Daily Maximum Temperature

Time: 10 days

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

Measure: Emergency Department/Clinic Presentations

Time: 28 days

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

Measure: Disease Severity Rating Day 7

Time: 7 days

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

Measure: Disease Severity Rating Day 15

Time: 15 days

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

Measure: Disease Severity Rating Day 28

Time: 28 days

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

Measure: Viral Load by Oropharyngeal Swab Day 9

Time: 9 days

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

Measure: Viral Load by Oropharyngeal Swab Day 15

Time: 15 days

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

Measure: Ventilator-Free Days

Time: 28 days

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

Measure: Therapeutic Oxygen-Free Days

Time: 28 days

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

Measure: Need for Hospital Admission at 15 Days

Time: 15 days

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

Measure: Need for Oxygen Therapy at 15 Days

Time: 15 days

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Primary Outcomes

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

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

Time: 7 days

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Secondary Outcomes

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

Measure: Daily Hypotensive Episodes

Time: 10 days

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

Measure: Hypotension Requiring Vasopressors

Time: 10 days

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

Measure: Acute Kidney Injury

Time: 10 days

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

Measure: Sequential Organ Failure Assessment (SOFA) Total Score

Time: 10 days

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

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

Time: 10 days

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

Measure: 28-Day Mortality

Time: 28 days

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

Measure: 90-Day Mortality

Time: 90 days

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

Measure: ICU Admission

Time: 10 days

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

Measure: Number of Ventilator-Free Days

Time: 10 days

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

Measure: Number of Therapeutic Oxygen-Free Days

Time: 10 days

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

Measure: Number of Vasopressor-Free Days

Time: 10 days

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

Measure: Length of ICU Stay

Time: 10 days

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

Measure: Length of Hospital Stay

Time: 10 days

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

Measure: Incidence of Respiratory Failure

Time: 10 days

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

Measure: Change in PROMIS Dyspnea Functional Limitations

Time: 10 days

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

Measure: Change in PROMIS Dyspnea Severity

Time: 10 days

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

Measure: Disease Severity Rating

Time: 10 days

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

Measure: Viral Load by Nasopharyngeal Swab Day 9

Time: 9 days

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

Measure: Viral Load by Nasopharyngeal Swab Day 15

Time: 15 days

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

Measure: Viral Load by Blood Day 9

Time: 9 days

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

Measure: Viral Load by Blood Day 15

Time: 15 days

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Primary Outcomes

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

Measure: COVID-19 diagnosis

Time: 14 days

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Secondary Outcomes

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

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

Time: 14 days

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Other Outcomes

Description: Mean/ Median in the two groups

Measure: Total number of quarantine days

Time: 14 days

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Description: Percentage in the two groups

Measure: Proportion of healthcare providers requiring quarantine

Time: 14 days

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Primary Outcomes

Description: 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

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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

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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

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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

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

Measure: ICU admission

Time: 28 days

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

Measure: Mechanical Ventilation

Time: 28 days

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

Measure: Mortality

Time: 28 days

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