Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

SUMMARY Background REGEN-COV is a combination of 2 monoclonal antibodies (casirivimab and imdevimab) that bind to two different sites on the receptor binding domain of the SARS-CoV-2 spike protein. We aimed to evaluate the efficacy and safety of REGEN-COV in patients admitted to hospital with COVID-19.Methods In this randomised, controlled, open-label platform trial, several possible treatments were compared with usual care in patients hospitalised with COVID-19. Eligible and consenting patients were randomly allocated (1:1) to either usual standard of care alone (usual care group) or usual care plus a single dose of REGEN-COV 8g (casirivimab 4g and imdevimab 4g) by intravenous infusion (REGEN-COV group). The primary outcome was 28-day mortality assessed first among patients without detectable antibodies to SARS-CoV-2 at randomisation (seronegative) and then in the overall population. The trial is registered with ISRCTN (50189673) and<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://clinicaltrials.gov">clinicaltrials.gov</jats:ext-link>(<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT04381936">NCT04381936</jats:ext-link>).Findings Between 18 September 2020 and 22 May 2021, 9785 patients were randomly allocated to receive usual care plus REGEN-COV or usual care alone, including 3153 (32%) seronegative patients, 5272 (54%) seropositive patients and 1360 (14%) patients with unknown baseline antibody status. In the primary efficacy population of seronegative patients, 396 (24%) of 1633 patients allocated to REGEN-COV and 451 (30%) of 1520 patients allocated to usual care died within 28 days (rate ratio 0·80; 95% CI 0·70-0·91; p=0·0010). In an analysis involving all randomised patients (regardless of baseline antibody status), 944 (20%) of 4839 patients allocated to REGEN-COV and 1026 (21%) of 4946 patients allocated to usual care died within 28 days (rate ratio 0·94; 95% CI 0·86-1·03; p=0·17). The proportional effect of REGEN-COV on mortality differed significantly between seropositive and seronegative patients (p value for heterogeneity = 0·001).Interpretation In patients hospitalised with COVID-19, the monoclonal antibody combination of casirivimab and imdevimab (REGEN-COV) reduced 28-day mortality among patients who were seronegative at baseline.Funding UK Research and Innovation (Medical Research Council) and National Institute of Health Research (Grant ref: MC_PC_19056)..

Medienart:	Preprint

Erscheinungsjahr:	2022
Erschienen:	2022

Enthalten in:	bioRxiv.org - (2022) vom: 31. Dez. Zur Gesamtaufnahme - year:2022

Sprache:	Englisch

Beteiligte Personen:

Horby, Peter W [VerfasserIn] Mafham, Marion [VerfasserIn] Peto, Leon [VerfasserIn] Campbell, Mark [VerfasserIn] Pessoa-Amorim, Guilherme [VerfasserIn] Spata, Enti [VerfasserIn] Staplin, Natalie [VerfasserIn] Emberson, Jonathan R [VerfasserIn] Prudon, Benjamin [VerfasserIn] Hine, Paul [VerfasserIn] Brown, Thomas [VerfasserIn] Green, Christopher A [VerfasserIn] Sarkar, Rahuldeb [VerfasserIn] Desai, Purav [VerfasserIn] Yates, Bryan [VerfasserIn] Bewick, Tom [VerfasserIn] Tiberi, Simon [VerfasserIn] Felton, Tim [VerfasserIn] Baillie, J Kenneth [VerfasserIn] Buch, Maya H [VerfasserIn] Chappell, Lucy C [VerfasserIn] Day, Jeremy N [VerfasserIn] Faust, Saul N [VerfasserIn] Jaki, Thomas [VerfasserIn] Jeffery, Katie [VerfasserIn] Juszczak, Edmund [VerfasserIn] Lim, Wei Shen [VerfasserIn] Montgomery, Alan [VerfasserIn] Mumford, Andrew [VerfasserIn] Rowan, Kathryn [VerfasserIn] Thwaites, Guy [VerfasserIn] Weinreich, David M [VerfasserIn] Haynes, Richard [VerfasserIn] Landray, Martin J [VerfasserIn]

Links:	Volltext [kostenfrei]

Themen:	570 Biology

doi:	10.1101/2021.06.15.21258542

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PPN (Katalog-ID):	XBI032018479