Table 2.

Shows the Clinical Trials Registered on ClinicalTrials.gov to October 20, 2020, Utilizing Antiviral Therapies for the Treatment of COVID-19

Study Identifier and Citation (Superscript)	Treatment Protocol	Study Phase; Estimated Enrolment (n)	Primary Outcome Measure(s)	Recruitment Status
NCT0449247583	Drug: IFNβ1a: rebif (R) is a purified 166 amino acid human IFNβ glycoprotein with an amino acid sequence identical to natural fibroblast derived human IFNβ. Each 0.5 mL prefilled syringe contains 44 µg of IFNβ1a, 4 mg human albumin, USP; 27.3 mg mannitol, USP; 0.4 mg sodium acetate; and water for injection, USP. Other: placebo: the IFNβ1a placebo contains either 0.5 mL 0.9% normal saline or 0.5 mL sterile water for injection. Drug: remdesivir: is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441,524. In addition to the active ingredient, the lyophilized formulation of remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide	Phase III n=1038	Time to recovery (Time frame: day 1 through day 29) Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: (1) hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care; (2) not hospitalized, limitation on activities and/or requiring home oxygen; (3) not hospitalized, no limitations on activities.	Recruiting
NCT0434397684	Drug: pegylated IFNλ 180 µg subcutaneous injection of pegylated IFNλ Other name: lambda	Phase II n=20	Undetectable COVID PCR at day 7 (Time frame: 1 week) Negative COVID PCR testing 7 days after first lambda dose	Enrolling by invitation
NCT0434376885	Experimental: hydroxychloroquine+lopinavir/ritonavir+IFNβ1a Experimental: hydroxychloroquine+lopinavir/ritonavir+IFNβ1b Active comparator: control group: hydroxychloroquine+lopinavir/ritonavir	Phase II n=60	Time to clinical improvement (Time frame: from date of randomization until 14 days later) Improvement of two points on a seven-category ordinal scale (recommended by the WHO: Coronavirus disease (COVID-2019) R&D. Geneva: WHO) or discharge from the hospital, whichever came first.	Completed
NCT0428070595	Placebo comparator: placebo: 200 mg of remdesivir placebo administered IV on day 1, followed by a 100 mg once-daily maintenance dose of remdesivir placebo while hospitalized for up to a 10-day total course n=286. Experimental: remdesivir: 200 mg of remdesivir administered IV on day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course n=286.	Phase III n=1062	Percentage of subjects reporting each severity rating on the 7-point ordinal scale (Time frame: day 15) 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 noninvasive 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.	Completed
NCT0429289996	Drug: remdesivir: administered as an IV infusion (other names: GS 5734TM, Veklury® Drug: standard of care: standard of care treatment for COVID-19 infection	Phase III n=4891	The odds ratio for improvement on a 7-point ordinal scale on day 14 (time frame: day 14) The odds ratio represents the odds of improvement in the ordinal scale between the treatment groups. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: (1) death (2) hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) (3) hospitalized, on noninvasive ventilation or high flow oxygen devices (4) hospitalized, requiring low flow supplemental oxygen (5) hospitalized, not requiring supplemental oxygen—requiring ongoing medical care (coronavirus (COVID-19) related or otherwise) (6) hospitalized, not requiring supplemental oxygen—no longer required ongoing medical care (other than per protocol remdesivir administration (7) not hospitalized	Completed
NCT0429273097	Drug: remdesivir: administered as an IV infusion (other names- GS 5734TM, veklury® Drug: standard of care: standard of care treatment for COVID-19 infection	Phase III n=1113	The odds ratio for improvement on a 7-point ordinal scale on day 11 (Time frame: day 11) The odds ratio represents the odds of improvement in the ordinal scale between the treatment groups. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: (1) death (2) hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) (3) hospitalized, on noninvasive ventilation or high flow oxygen devices (4) hospitalized, requiring low flow supplemental oxygen (5) hospitalized, not requiring supplemental oxygen—requiring ongoing medical care (coronavirus (COVID-19) related or otherwise) (6) hospitalized, not requiring supplemental oxygen—no longer required ongoing medical care (other than per protocol remdesivir administration (7) not hospitalized.	Completed
NCT0440926298	Experimental: remdesivir+tocilizumab (RDV+TCZ): participants assigned to the RDV+TCZ arm will receive an RDV loading dose followed by one infusion of TCZ on day 1, and a once-daily maintenance dose of remdesivir from days 2–10. Interventions: drug: remdesivir; drug: tocilizumab Active comparator: remdesivir+placebo (RDV+placebo): participants assigned to the RDV+placebo arm will receive an RDV loading dose followed by one infusion of TCZ-placebo on day 1, and a once-daily maintenance dose of RDV from days 2–10. Interventions: drug: remdesivir; drug: placebo	Phase III n=450	Clinical status as assessed by the investigator using a 7-category ordinal scale of clinical status on day 28 (Time frame: day 28)	Recruiting
NCT04381936104	Drug: lopinavir-ritonavir: lopinavir 400 mg-ritonavir 100 mg by mouth (or nasogastric tube) every 12 h for 10 days. Drug: corticosteroid: corticosteroid in the form of dexamethasone administered as an oral (liquid or tablets) or IV preparation 6 mg once daily for 10 days. In pregnancy or breastfeeding women, prednisolone 40 mg administered by mouth (or IV hydrocortisone 80 mg twice daily) should be used instead of dexamethasone. Corticosteroid (in children ≤44 weeks gestational age, or >44 weeks gestational age with PIMS-TS only) in the form of hydrocortisone or methylprednisolone sodium succinate (see protocol for timing and dosage) Drug: hydroxychloroquine: hydroxychloroquine by mouth for a total of 10 days (see protocol for timing and dosage). Drug: azithromycin: azithromycin 500 mg by mouth (or nasogastric tube) or IV once daily for 10 days. Biological: convalescent plasma: single unit of ABO compatible convalescent plasma (275mL±75 mL) IV per day on study days 1 (as soon as possible after randomization) and 2 (with a minimum of 12 h interval between first and second units) Drug: tocilizumab: tocilizumab by IV infusion with the dose determined by body weight (see protocol for dosage) Biological: immunoglobulin: IV immunoglobulin (IVIg) for children >44 weeks gestational age and <18 years with PIMS-TS only (see protocol for dosage) Drug: synthetic neutralizing antibodies: for participants ≥12 years only: a single dose of REGN10933+REGN10987 8 g (4 g of each monoclonal antibody) in 250 mL 0.9% saline infused IV over 60in±15 min as soon as possible after randomization (other name: REGN-COV2)	Phase: II, III n=15,000	All-cause mortality (Time frame: within 28 days after randomization) For each pairwise comparison with the “no additional treatment“ arm, the primary objective is to provide reliable estimates of the effect of study treatments on all-cause mortality.	Recruiting
NCT04260594109	Drug: arbidol Arbidol tablets: take 2 tablets/time, 3 times/day for 14–20 days Other name: the basic treatment used by the investigator was based on the condition of the patient Other: basic treatment basic treatment	Phase IV n=380	Virus negative conversion rate in the first week (Time frame: first week)	Not yet recruiting
NCT04347980113	Drug: dexamethasone and hydroxychloroquine: patients included in the hydroxychloroquine/dexamethasone group will benefit from standardized ventilatory management and administration of hydroxychloroquine in the same manner as the hydroxychloroquine group. They will receive in addition to dexamethasone at a rate of 20 mg IV for 15 min once a day for 5 days (D1 to D5) then at a rate of 10 mg per day from D6 to D10. If the patient is extubated before the tenth day, he will receive his last dose of dexamethasone before. (Other name: standard ventilatory management) Drug: hydroxychloroquine: patients included in the hydroxychloroquine group will benefit from standardized ventilatory management. Patients included in the hydroxychloroquine group will receive 200 mg⨰3/day enterally from J1 of the HCQ for 10 days. If the patient is extubated before the tenth day, he will receive his last dose of HCQ before. (Other name: standard ventilatory management)	Phase III n=122	Day-28 mortality (time frame: 28 days after randomization) Mortality rate evaluated 28 days after randomization	Recruiting
NCT04334928114	Drug: emtricitabine/tenofovir disoproxil Emtricitabine/tenofovir disoproxil, 200 mg/245 mg tablets. A dose of one tablet once a day will be administered. Drug: hydroxychloroquine Hydroxychloroquine, 200 mg tablets. A dose of one tablet once a day will be administered. Drug: placebo: emtricitabine/tenofovir disoproxil placebo Placebo: tablets similar in appearance to emtricitabine/tenofovir disoproxil Drug: placebo: hydroxychloroquine Placebo: tablets similar in appearance to hydroxychloroquine	Phase III n=4000	Number of confirmed symptomatic infections of SARS-CoV-2 (COVID-19) (time frame: 12 weeks)	Recruiting
NCT04513184118	Drug: IV dexamethasone 6 mg from day 1 to 10 after randomization Other name: ST Drug: nasal dexamethasone 0.12 mg/kg/daily for 3 days from day 1, followed by 0.06 mg/kg/daily from day 4 to 10 after randomization. Other name: nasal DXM	Phase II n=60	Time of clinical improvement (time frame: 10 days after randomization) Evaluation of the clinical status of patients after randomization, defined as a two-point improvement in the WHO 7-point ordinal scale	Recruiting
NCT04509973119	Experimental: dexamethasone 12 mg IV bolus injection of dexamethasone 12 mg once daily in addition to standard care for up to 10 days. We will allow the use of betamethasone 12 mg at sites, where dexamethasone is not available. Intervention: drug: dexamethasone Active comparator: dexamethasone 6 mg IV bolus injection of dexamethasone 6 mg once daily in addition to standard care for up to 10 days. We will allow the use of betamethasone 6 mg at sites, where dexamethasone is not available. Intervention: Drug: dexamethasone	Phase III n=1000	Days alive without life support at day 28 (time frame: day 28 after randomization) Days alive without life support (ie invasive mechanical ventilation, circulatory support or renal replacement therapy) from randomization to day 28	Recruiting
NCT04310228133	Drug: favipiravir combined with tocilizumab Favipiravir: On the first day, 1600 mg each time, twice a day; from the second to the seventh day, 600 mg each time, twice a day. Oral administration, the maximum number of days taken is not more than 7 days. Tocilizumab: the first dose is 4~8 mg/kg and the recommended dose is 400 mg. For fever patients, an additional application (the same dose as before) is given if there is still fever within 24 h after the first dose and the interval between two medications ≥12 h. IV infusion, the maximum of cumulative number is two, and the maximum single dose does not exceed 800 mg. Drug: favipiravir On the first day, 1600 mg each time, twice a day; from the second to the seventh day, 6 00 mg each time, twice a day. Oral adm inistration, the maximum number of days taken is not more than 7 days. Drug: tocilizumab The first dose is 4~8 mg/kg and the recommended dose is 400 mg. For fever patients, an additional application (the same dose as before) is given if there is still fever within 24 h after the first dose and the interval between two medications ≥12 h. IV infusion, The maximum of cumulative number is two, and the maximum single dose does not exceed 800 mg.	Phase: not applicable n=150	Clinical cure rate (time frame: 3 months) Definition of clinical cure: the viral load of the respiratory specimen was negative for two consecutive times (the interval between the two tests was greater than or equal to one day), the lung image improved, and the body temperature returned to normal for more than 3 days, and the clinical manifestation improved.	Recruiting
NCT04320615134	Drug: tocilizumab (TCZ) Participants will receive one dose of IV TCZ. One additional dose may onee given if clinical symptoms worsen or show no improvement. Drug: placebo Participants will receive one dose of IV placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen or show no improvement.	Phase: II n=450	The primary and secondary endpoints of the study include clinical status, mortality, mechanical ventilation, and ICU variables.	Completed
NCT04317092135	Drug: tocilizumab injection Tocilizumab 8 mg/kg (up to a maximum of 800 mg per dose), with an interval of 12 h.	Phase: II n=400	Two primary outcome measures: arrest in deterioration of pulmonary function, and improvement in pulmonary function.	Recruiting
NCT04315480136	Single dose of tocilizumab 8 mg/kg	Phase: II n=38	To evaluate its role in the virus-induced cytokine storm, in blocking deterioration of lung function or even promoting a rapid improvement of clinical conditions, preventing nasotracheal intubation and/or death.	Active, not recruiting
NCT04322773137	Drug: roactemra IV single dose treatment with tocilizumab 400 mg IV Other name: tocilizumab 400 mg Drug: roactemra sc single dose treatment with tocilizumab 2⨰162 mg subcutaneously Other name: tocilizumab 2⨰162 mg Drug: kevzara sc single dose treatment with sarilumab 1⨰200 mg subcutaneously Other name: sarilumab 1⨰200 mg Other: standard medical care management as usual	Phase: II n=200	To compare the effect of either one of three IL-6 inhibitor administrations (ie IV tocilizumab, subcutaneous tocilizumab, and subcutaneous sarilumab), relative to the standard of care, in patients with severe SARS-CoV-2 pneumonia	Recruiting
NCT04331808138–140	Drug: tocilizumab Tocilizumab 8 mg/kg D1 and if no response (no decrease of oxygen requirement) a second injection at D3.	Phase: II n=129	A significantly lower proportion of the patients in tocilizumab arm attained the primary outcome of need for ventilation or death at day 14	Active, not recruiting
NCT04315298141,142	Drug: sarilumab Single or multiple IV doses of sarilumab. Additional doses may be administered if the patient meets protocol defined criteria. Other names: kevzara®/REGN88/SAR153191 Drug: placebo Single or multiple IV doses of placebo to match sarilumab administration	Phase: II, III n=1912	The first part is recruiting patients across multiple sites in the USA and will evaluate the effect of sarilumab on fever and need for supplemental oxygen. The second, larger, part of the trial will evaluate improvement in longer-term outcomes, including prevention of mortality and reduction in need for mechanical ventilation, supplemental oxygen, and/or hospitalization. The early results from this study seem to show that its utility may be reserved for the critically ill patients	Completed
NCT04324073143	Drug: sarilumab (an IV dose of 400 mg of sarilumab in a one-hour infusion at D1	Phase: II, III n=239	The recruited participants were COVID-19 patients with moderate, severe or critical pneumonia. The trials aim to compare the outcomes of sarilumab-treated patients with those receiving outcomes of standard of care as well as with patients being treated with other immunomodulators. More studies have since been registered or initiated for assessing sarilumab	Active, not recruiting
NCT04329650144	Drug: siltuximab A single-dose of 11 mg/kg of siltuximab will be administered by IV infusion. Drug: methylprednisolone A dose of 250 mg/24 h of methylprednisolone during 3 days followed by 30 mg/24 h during 3 days will be administered by IV infusion. If the patient is taking lopinavir/ritonavir, the dose will be 125 mg/24 h during 3 days followed by 15 mg/24 h during 3 days.	Phase: II, III n=239	Compare efficacy and safety of siltuximab vs corticosteroids in hospitalized patients with COVID19 pneumonia proportion of patients requiring ICU admission at any time within the study period	Recruiting
NCT04443881145	Drug: anakinra 149 mg/mL prefilled syringe (Kineret) Anakinra (100 mg/6 h) IV infusión during 15 days	Phase: II, III n=180	Treatment success, defined as number of patients not requiring mechanical ventilation to assess the effect of anakinra in addition to standard treatment on the need for mechanical ventilation in patients with severe COVID-19 and CSS pneumonia. (Time frame: day 15) Treatment success, defined as number of patients not requiring mechanical ventilation by day 15. Number of patients not requiring mechanical ventilation to assess the effect of anakinra in addition to standard treatment on the need for mechanical ventilation in patients with severe COVID-19 and CSS pneumonia. (Time frame: day 28) Number of patients not requiring mechanical ventilation Time to mechanical ventilation to assess the effect of anakinra in addition to standard treatment on the need for mechanical ventilation in patients with severe COVID-19 and CSS pneumonia. ((Time frame: up to 28 days) Time to mechanical ventilation Time to oxygen saturation normalization to assess the effect of anakinra in addition to standard treatment on the need for mechanical ventilation in patients with severe COVID-19 and CSS pneumonia. (Time frame: up to 28 days) Time to oxygen saturation normalization Stay in ICU and hospitalization to assess the effect of anakinra in addition to standard treatment on the need for mechanical ventilation in patients with severe COVID-19 and CSS pneumonia. (Time frame: up to 28 days) Stay in ICU and hospitalization	Recruiting