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dc.contributor.authorRECOVERY Collaborative Group
dc.contributor.authorDhasmana, Devesh J
dc.contributor.authorHorby, Peter W
dc.contributor.authorLandray, Martin J
dc.identifier.citationRECOVERY Collaborative Group , Dhasmana , D J , Horby , P W & Landray , M J 2022 , ' Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY) : a randomised, controlled, open-label, platform trial ' , The Lancet , vol. 399 , no. 10325 , pp. 665-676 .
dc.identifier.otherPubMedCentral: PMC8830904
dc.descriptionThe RECOVERY trial is supported by grants to the University of Oxford (Oxford, UK) from UK Research and Innovation (UKRI; Medical Research Council) and the National Institute of Health Research (NIHR; MC_PC_19056), the Wellcome Trust (222406/Z/20/Z) through the COVID-19 Therapeutics Accelerator, and by core funding provided by the NIHR Oxford Biomedical Research Centre, the Wellcome Trust, the Bill and Melinda Gates Foundation, the Foreign, Commonwealth and Development Office, Health Data Research UK, the Medical Research Council Population Health Research Unit, the NIHR Health Protection Unit in Emerging and Zoonotic Infections, and NIHR Clinical Trials Unit Support Funding. TJ is supported by a grant from UK Medical Research Council (MC_UU_00002/14) and an NIHR Senior Research Fellowship (NIHR-SRF-2015-08-001).en
dc.description.abstractBackground : 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. Methods : 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 (NCT04381936). Findings : Between Sept 18, 2020, and May 22, 2021, 9785 patients enrolled in RECOVERY were eligible for casirivimab and imdevimab, of which 4839 were randomly assigned to casirivimab and imdevimab plus usual care and 4946 to usual care alone. 3153 (32%) of 9785 patients were seronegative, 5272 (54%) were seropositive, and 1360 (14%) had unknown baseline antibody status. 812 (8%) patients were known to have received at least one dose of a SARS-CoV-2 vaccine. In the primary efficacy population of seronegative patients, 396 (24%) of 1633 patients allocated to casirivimab and imdevimab versus 452 (30%) of 1520 patients allocated to usual care died within 28 days (rate ratio [RR] 0·79, 95% CI 0·69-0·91; p=0·0009). In an analysis of all randomly assigned patients (regardless of baseline antibody status), 943 (19%) of 4839 patients allocated to casirivimab and imdevimab versus 1029 (21%) of 4946 patients allocated to usual care died within 28 days (RR 0·94, 95% CI 0·86-1·02; p=0·14). The proportional effect of casirivimab and imdevimab on mortality differed significantly between seropositive and seronegative patients (p value for heterogeneity=0·002). There were no deaths attributed to the treatment, or meaningful between-group differences in the pre-specified safety outcomes of cause-specific mortality, cardiac arrhythmia, thrombosis, or major bleeding events. Serious adverse reactions reported in seven (<1%) participants were believed by the local investigator to be related to treatment with casirivimab and imdevimab. Interpretation : In patients admitted to hospital with COVID-19, the monoclonal antibody combination of casirivimab and imdevimab reduced 28-day mortality in patients who were seronegative (and therefore had not mounted their own humoral immune response) at baseline but not in those who were seropositive at baseline.
dc.relation.ispartofThe Lanceten
dc.subjectAged, 80 and overen
dc.subjectAntibodies, monoclonal, humanized/adverse effectsen
dc.subjectAntibodies, viral/blooden
dc.subjectAntiviral agents/adverse effectsen
dc.subjectCOVID-19/drug therapyen
dc.subjectDrug therapy, combinationen
dc.subjectInfusions, intravenousen
dc.subjectTreatment outcomeen
dc.subjectQR180 Immunologyen
dc.subjectSDG 3 - Good Health and Well-beingen
dc.titleCasirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY) : a randomised, controlled, open-label, platform trialen
dc.typeJournal articleen
dc.contributor.institutionUniversity of St Andrews. School of Medicineen
dc.contributor.institutionUniversity of St Andrews. Infection and Global Health Divisionen
dc.description.statusPeer revieweden

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