Table 4.

Select Treatment and Prophylaxis Trials Targeting the Immune System

Drug Name	Mechanism of Action	NCT Number	Title	Study Population	Targeted Enrollment	Study Design	Primary Outcome Measure
Treatment Trials
IFN-α1β	Immunomodulatory	NCT04293887	Efficacy and Safety of IFN-α1β in the Treatment of Novel Coronavirus Patients	Age ≥18 yrs with clinically diagnosed coronavirus pneumonia within 7 days, including RT-PCR evidence of coronavirus and symptoms	328	Randomized, open-label, single-arm	Incidence of side effects within 14 days including dyspnea, pulse O2 ≤94%, and RR ≥24 breaths/min
Methylprednisolone	Immunomodulatory	NCT04273321	Efficacy and Safety of Corticosteroids in COVID-19	Age >18 yrs, diagnosis of novel coronavirus pneumonia (COVID-19)	400	Randomized, open-label, single-arm	Incidence of treatment failure in 14 days
Methylprednisolone	Immunomodulatory	NCT04244591	Glucocorticoid Therapy for COVID-19 Critically Ill Patients With Severe Acute Respiratory Failure	Age >18 yrs, RT-PCR–confirmed infection, symptoms for >7 days, PaO2/FiO2 <200, positive pressure ventilation or HFNC higher than 45 l/min for <48 h, requiring ICU admission	80	Randomized, open-label of glucocorticoid therapy or standard of care	Murray lung injury score at 7 days
Sarilumab	Immunomodulatory	NCT04315298	Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19	Age ≥18 yrs; confirmation of SARS-CoV-2 infection by RT-PCR; current hospitalization with evidence of pneumonia and severe disease, critical disease, or multiorgan system dysfunction	400	Adaptive, randomized, double-blind, placebo-controlled with high and low doses	Percent change in C-reactive protein levels at 4 days Percentage of patients reporting clinical severity rated on a 7-point ordinal scale
Siltuximab	Immunomodulatory	NCT04329650	Efficacy and Safety of Siltuximab vs. Corticosteroids in Hospitalized Patients With COVID-19 Pneumonia	Age ≥18 yrs; confirmation of SARS-CoV-2 infection by RT-PCR; current hospitalization with evidence of pneumonia; maximum O2 support of 35%	100	Randomized, open-label of siltuximab or methylprednisolone	Proportion of patients requiring ICU admission at 29 days
Tocilizumab	Immunomodulatory	NCT04317092	Tocilizumab in COVID-19 Pneumonia (TOCIVID-19)	No age or sex limit; SARS-CoV-2 infection by RT-PCR, current hospitalization secondary to pneumonia; pulse O2 ≤93%, requiring O2, or requiring mechanical ventilation (invasive or noninvasive)	400	Open-label, single-arm	Mortality at 1 month
Tocilizumab	Immunomodulatory	NCT04320615	A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia (COVACTA)	Age ≥18 yrs; hospitalized with COVID-19 pneumonia per WHO criteria; pulse O2 ≤93% or PaO2/FiO2 <300	330	Randomized, double-blind placebo controlled	Clinical status using a 7-category ordinal scale at 28 days
Anakinra, siltuximab, or tocilizumab	Immunomodulatory	NCT04330638	Treatment of COVID-19 Patients With Anti-interleukin Drugs (COV-AID)	Age ≥18 yrs; hospitalized with confirmed COVID-19 diagnosis by RT-PCR or other laboratory test; hypoxia defined by PaO2/FiO2; CXR or CT scan with bilateral infiltrates	342	Randomized, open-label (1:1:1:1) to anakinra, or siltuximab, or anakinra + siltuximab, or tocilizumab, or anakinra + tocilizumab	Time to clinical improvement at 15 days
Prophylaxis Trial
Recombinant human IFN-α1β and thymosin α1	Immunomodulatory	NCT04320238	Experimental Trial of rhIFNα Nasal Drops to Prevent 2019-nCOV in Medical Staff	Age 18 to 65 yrs, formally serving as medical staff in Taihe Hospital	2,944	2-arm, open-label to IFN-α1β in a low-risk group and IFN-α1β and thymosin α1 in a high-risk group	New COVID-19 diagnosis at 28 days

For an up-to-date listing of trials, search for “COVID-19” at the ClinicalTrials.gov website.

CT = computed tomography; CXR = chest x-ray; HFNC = high flow nasal cannula; ICU = intensive care unit; IFN = interferon; rhIFN = recombinant human interferon; WHO = World Health Organization; other abbreviations as in Tables 1, 2, and 3.