meta|Evidence - COVID-19
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casirivimab/imdevimab (Ronapreve) (n=4839) vs. standard of care (n=4946)
randomized controlled trial some concerns about risk of bias
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.
casirivimab/imdevimab (Ronapreve) (n=912) vs. placebo (n=452)
randomized controlled trial some concerns about risk of bias
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).
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