Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
Abstract
Casirivimab and imdevimab are non-competing monoclonal antibodies that bind to two different sites on the receptor binding domain of the SARS-CoV-2 spike glycoprotein, blocking viral entry into host cells. We aimed to evaluate the efficacy and safety of casirivimab and imdevimab administered in combination in patients admitted to hospital with COVID-19.
RECOVERY is a randomised, controlled, open-label platform trial comparing several possible treatments with usual care in patients admitted to hospital with COVID-19. 127 UK hospitals took part in the evaluation of casirivimab and imdevimab. Eligible participants were any patients aged at least 12 years admitted to hospital with clinically suspected or laboratory-confirmed SARS-CoV-2 infection. Participants were randomly assigned (1:1) to either usual standard of care alone or usual care plus casirivimab 4 g and imdevimab 4 g administered together in a single intravenous infusion. Investigators and data assessors were masked to analyses of the outcome data during the trial. The primary outcome was 28-day all-cause mortality assessed by intention to treat, first only in patients without detectable antibodies to SARS-CoV-2 infection at randomisation (ie, those who were seronegative) and then in the overall population. Safety was assessed in all participants who received casirivimab and imdevimab. The trial is registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936).
Citation impact
- FWCI
- 35.28
- Percentile
- 100%
- References
- 51
Authors
5000Topics & keywords
- Medicine
- Randomized controlled trial
- Internal medicine
- Confidence interval
- Population
- Coronavirus disease 2019 (COVID-19)
- Intention-to-treat analysis
- Pediatrics
- Good health and well-being
Funding
- BABill and Melinda Gates Foundation
- RPRegeneron Pharmaceuticals
- WTWellcome TrustAward: 222406/Z/20/Z
- URUK Research and InnovationAward: MC_UU_00002/14
- NINational Institute for Health and Care ResearchAwards: SRF-2015-08-001, NIHR-SRF-2015-08-001
- DODepartment of Health and Social Care
- UOUniversity of Oxford
- PHPublic Health England
- FCForeign, Commonwealth and Development Office
- MRMedical Research CouncilAwards: NIHR-SRF-2015-08-001, MR/T005114/1, MC_UU_00002/14, COVID-19
- NONIHR Oxford Biomedical Research Centre
- NNNIHR Nottingham Biomedical Research Centre