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amubarvimab/romlusevimab (BRII-196 and BRII-198-Brii Biosciences) (n=179) vs. placebo (n=183)
randomized controlled trial
BRII-196 plus BRII-198
Placebo
Randomisation allocation was 2:1:2:1 to sotrovimab, matching placebo for sotrovimab, BRII-196 plus BRII-198, or matching placebo for BRII-196 plus BRII-198. The concurrent placebo groups were pooled for analyses, resulting in approximately a 1:1:1 allocation ofsotrovimab to BRII-196 plus BRII-198 to placebo. All patients received remdesivir. Other treatments for COVID-19, including oxygen, respiratory support, and corticosteroids, were administered at the discretion of the treating clinician per local standard of care.
COVID 19 hospitalized
Double-blind.
43 hospitals in the USA, Denmark, Switzerland, and Poland.
Prematurely discontinued for futility (based on pulmonary and pulmonary-plus ordinal outcome scale at day 5) after enrollment of 300 patients. *Warning! The spread of new Sars-Cov2 variants is constantly evolving, this study was performed in a different viral context than today, its results should be interpreted accordingly.*
bamlanivimab monotherapy (n=163) vs. placebo (n=151)
randomized controlled trial
LY-CoV555
LY-CoV555 at a dose of 7000 mg as a single intravenous infusion over a 1-hour period
placebo
supportive care as background therapy, including the antiviral drug remdesivir and,when indicated, supplemental oxygen and glucocorticoids
COVID 19 hospitalized
double-blind
31 sites in US, Denmark, Singapore
Study stopped for futility (seven-category ordinal scale on day 5). As of April 2021, regulatory authorities recommend that bamlanivumab no longer be used because of the potential risk of treatment failure due to the circulation of resistant variants of SARS-CoV-2.
casirivimab/imdevimab (Ronapreve) (n=4839) vs. standard of care (n=4946)
randomized controlled trial
REGEN-COV
Usual care plus single dose of REGEN-COV 8g (casirivimab 4g and imdevimab 4g) in 250ml 0.9% saline infused intravenously over 60 minutes as soon as possible after randomisation.
Usual care
Usual care alone
As a platform trial, and in a factorial design, patients could be simultaneously randomised to other treatment groups: i) azithromycin versus usual care, ii) colchicine versus usual care, iii) aspirin versus usual care, and iv) baricitinib versus usual care. Until 24 January 2021, the trial also allowed a subsequent randomisation for patients with progressive COVID-19 to tocilizumab versus usual care.
COVID 19 hospitalized
Pregnant or breastfeeding women were eligible for inclusion. For some patients, REGEN-COV was unavailable at the hospital at the time of enrolment or was considered by the managing physician to be either definitely indicated or definitely contraindicated. These patients were excluded from the randomised comparison between REGEN-COV and usual care.
Open-label.
123 UK hospitals.
Prior to any unblinding of results, the trial steering committee specified that hypothesis-testing of the effect of allocation to REGEN-COV on 28-day mortality (and secondary outcomes) would first be done only in seronegative participants. All decisions about this modification to the analytical plan were made before recruitment was complete and before any members of the trial steering committee (who are responsible for drafting and approving the SAP) or investigators had access to any unblinded analyses of clinical outcome data for the REGN-COV2 comparison. No members of the independent Data Monitoring Committee (who are the only individuals who can review interim unblinded analyses) were involved in this change.
*Warning! The spread of new Sars-Cov2 variants is constantly evolving, this study was performed in a different viral context than today, its results should be interpreted accordingly.* 9785 patients including 3153 seronegative patients, 5272 seropositive patients, and 1360 patients with unknown baseline antibody status. Baseline presence of anti-SARS-CoV-2 antibodies was to be determined for each participant using serum samples taken at the time of randomisation.
cilgavimab and tixagevimab (Evusheld) (n=710) vs. placebo (n=707)
randomized controlled trial
intravenous tixagevimab 300 mg/cilgavimab 300 mg
placebo
in addition to remdesivir and other standard care
COVID 19 hospitalized
double-blind
81 sites on four continents
efficacy and safety analyses were performed in the modified intention-to-treat population, defined as participants who received a complete or partial infusion of tixagevimab/cilgavimab or placebo
neutralizing antibody (n=301) vs. placebo (n=292)
randomized controlled trial
Hyperimmune intravenous immunoglobulin (hIVIG) to SARS-CoV-2 derived from recovered donors
A dose of hIVIG of 400 mg/kg bodyweight, capped at 40g. Infusion of hIVIG was to commence at a rate of 0.5 mg/kg per min for approximately 30 min. If tolerated, the rate of infusion could be doubled after intervals of not less than 30 min up to a maximum of 4 mg/kg per min.
Placebo
Equivalent volume of saline.
All participants received supportive care reflecting local practice and national guidelines. Standard of care background therapy included up to 10 days of study provided remdesivir unless contraindicated. Other aspects of standard care including corticosteroids, prophylactic anti-coagulation, supplemental oxygen,and other end-organ support, as clinically indicated.
COVID 19 hospitalized
Double-blind.
63 sites in Argentina, Denmark, Germany, Greece, Indonesia, Israel, Japan, Nigeria, Spain, UK, USA.
Ordinal outcome is based on a seven-category ordinal scale (1=can independently undertake usual activities with minimal or no symptoms; 2=no supplemental oxygen, symptomatic and unable to undertake usual activities; 3=supplemental oxygen <4 L/min; 4=supplemental oxygen ≥4 L/min or symptoms/signs of extra-pulmonary conditions; 5=non-invasive ventilation, high-flow oxygen, or symptoms and signs of acute stroke (National Institute of Health Stroke Scale >14); 6=invasive ventilation, extracorporeal membrane oxygenation, mechanical circulatory support, vasopressor therapy or renal replacement therapy; 7=death)
sotrovimab (Xevudy; VIR-7831) (n=184) vs. placebo (n=183)
randomized controlled trial
VIR-7831 Sotrovimab
Standard of care plus single intravenous dose of sotrovimab 500mg over 60 minutes as soon as possible after randomisation.
Placebo
Standard of care plus placebo (0.9% sodium chloride).
Randomisation allocation was 2:1:2:1 to sotrovimab, matching placebo for sotrovimab, BRII-196 plus BRII-198, or matching placebo for BRII-196 plus BRII-198. The concurrent placebo groups were pooled for analyses, resulting in approximately a 1:1:1 allocation ofsotrovimab to BRII-196 plus BRII-198 to placebo. All patients received remdesivir. Other treatments for COVID-19, including oxygen, respiratory support, and corticosteroids, were administered at the discretion of the treating clinician per local standard of care.
COVID 19 hospitalized
Patients with laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Patients were eligible for enrolment if they were receiving no oxygen therapy or standard oxygen therapy via a nasal cannula or mask, but were excluded if they were receiving high-flow oxygen via nasal cannula, non-invasive ventilation, or invasive mechanical ventilation, or met any of the other criteria for acute organ failure or major extrapulmonary manifestations of COVID-19.
Double-blind.
43 hospitals in the USA, Denmark, Switzerland, and Poland.
*Warning! The spread of new Sars-Cov2 variants is constantly evolving, this study was performed in a different viral context than today, its results should be interpreted accordingly.* Prematurely discontinued for futility (based on pulmonary and pulmonary-plus ordinal outcome scale at day 5) after enrollment of 300 patients.
casirivimab/imdevimab (Ronapreve) (n=912) vs. placebo (n=452)
randomized controlled trial
REGEN-COV Casirivimab and imdevimab
2.4 g or 8.0 gREGEN-COV (1.2 g casirivimab and1.2 g imdevimab)
Placebo
Single intravenous dose.
3 arms ratio 1:1:1 : 2.4 g REGEN-COV (1.2 g casirivimab and1.2 g imdevimab), 8.0 g REGEN-COV (4.0 g casirivimab and 4.0 g imdevimab), or placebo as a single intravenous dose. Standard-of-care treatments for Covid-19, per the investigator, were permitted.
COVID-19 mild to moderate
Double-blind.
103 sites in the United States, Brazil, Chile, Mexico, Moldova, and Romania
Primary endpoints were tested hierarchically.
*Warning! The spread of new Sars-Cov2 variants is constantly evolving, this study was performed in a different viral context than today, its results should be interpreted accordingly.* Trial was stopped earlier than planned (due to low enrollment prior to the surge associated with the Delta variant).
equine polyclonal antibodies INM005 (n=118) vs. placebo (n=123)
randomized controlled trial
Equine polyclonal antibodies INM005
placebo
COVID-19 severe or critically
double-blind
19 hospitals of Argentina
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