Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY) a randomised controlled, open-label, platform trial

RECOVERY Collaborative Group

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Abstract

Background: Many patients with COVID-19 have been treated with plasma containing anti-SARS-CoV-2 antibodies. We aimed to evaluate the safety and efficacy of convalescent plasma therapy in patients admitted to hospital with COVID-19. Methods: This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]) is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. The trial is underway at 177 NHS hospitals from across the UK. Eligible and consenting patients were randomly assigned (1:1) to receive either usual care alone (usual care group) or usual care plus high-titre convalescent plasma (convalescent plasma group). The primary outcome was 28-day mortality, analysed on an intention-to-treat basis. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936. Findings: Between May 28, 2020, and Jan 15, 2021, 11558 (71%) of 16287 patients enrolled in RECOVERY were eligible to receive convalescent plasma and were assigned to either the convalescent plasma group or the usual care group. There was no significant difference in 28-day mortality between the two groups: 1399 (24%) of 5795 patients in the convalescent plasma group and 1408 (24%) of 5763 patients in the usual care group died within 28 days (rate ratio 1·00, 95% CI 0·93–1·07; p=0·95). The 28-day mortality rate ratio was similar in all prespecified subgroups of patients, including in those patients without detectable SARS-CoV-2 antibodies at randomisation. Allocation to convalescent plasma had no significant effect on the proportion of patients discharged from hospital within 28 days (3832 [66%] patients in the convalescent plasma group vs 3822 [66%] patients in the usual care group; rate ratio 0·99, 95% CI 0·94–1·03; p=0·57). Among those not on invasive mechanical ventilation at randomisation, there was no significant difference in the proportion of patients meeting the composite endpoint of progression to invasive mechanical ventilation or death (1568 [29%] of 5493 patients in the convalescent plasma group vs 1568 [29%] of 5448 patients in the usual care group; rate ratio 0·99, 95% CI 0·93–1·05; p=0·79). Interpretation: In patients hospitalised with COVID-19, high-titre convalescent plasma did not improve survival or other prespecified clinical outcomes. Funding: UK Research and Innovation (Medical Research Council) and National Institute of Health Research.

Original languageEnglish
Pages (from-to)2049-2059
Number of pages11
JournalThe Lancet
Volume397
Issue number10289
Early online date14 May 2021
DOIs
Publication statusPublished - 29 May 2021

Bibliographical note

Funding Information:
We would like to thank the thousands of patients who participated in this trial. We would also like to thank the many doctors, nurses, pharmacists, other allied health professionals, and research administrators at 177 NHS hospital organisations across the whole of the UK, supported by staff at the National Institute of Health Research (NIHR) Clinical Research Network, NHS DigiTrials, NHS Blood and Transplant, the Scottish National Blood Transfusion Service, the Welsh Blood Service, the Northern Ireland Blood Transfusion Service, Public Health England, Department of Health & Social Care, the Intensive Care National Audit & Research Centre, Public Health Scotland, National Records Service of Scotland, the Secure Anonymised Information Linkage at University of Swansea, Swansea, UK, and the NHS in England, Scotland, Wales and Northern Ireland. The RECOVERY trial is supported by a grant to the University of Oxford from?UK Research and Innovation (UKRI) and NIHR (MC_PC_19056), by the Department of Health and Social Care (DHSC), UKRI, and NIHR COVID-19 Rapid Response Grant (COV19-RECPLA), and by core funding provided by NIHR Oxford Biomedical Research Centre, the Wellcome Trust, the Bill & Melinda Gates Foundation, the Department for International Development, Health Data Research UK, the Medical Research Council Population Health Research Unit, the NIHR Health Protection Unit in Emerging and Zoonotic Infections, NHS Blood and Transplant Research and Development Funding, EU's Horizon 2020 research and innovation programme (SUPPORT-E - 101015756), and NIHR Clinical Trials Unit Support Funding. TJ is supported by a grant from UK Medical Research Council (MC_UU_0002/14) and an NIHR Senior Research Fellowship (NIHR-SRF-2015-08-001). WSL is supported by core funding provided by NIHR Nottingham Biomedical Research Centre. AbbVie contributed some supplies of lopinavir?ritonavir for use in this trial. Tocilizumab was provided free of charge for this trial by Roche. REGN-COV2 was provided free of charge for this trial by Regeneron. The collection of plasma was funded by the DHSC through core funding and funding under COVID-19 and EU SoHo Grant. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR, NHS Blood and Transplant, the DHSC, or the EU.

Funding Information:
We would like to thank the thousands of patients who participated in this trial. We would also like to thank the many doctors, nurses, pharmacists, other allied health professionals, and research administrators at 177 NHS hospital organisations across the whole of the UK, supported by staff at the National Institute of Health Research (NIHR) Clinical Research Network, NHS DigiTrials, NHS Blood and Transplant, the Scottish National Blood Transfusion Service, the Welsh Blood Service, the Northern Ireland Blood Transfusion Service, Public Health England, Department of Health & Social Care, the Intensive Care National Audit & Research Centre, Public Health Scotland, National Records Service of Scotland, the Secure Anonymised Information Linkage at University of Swansea, Swansea, UK, and the NHS in England, Scotland, Wales and Northern Ireland. The RECOVERY trial is supported by a grant to the University of Oxford from UK Research and Innovation (UKRI) and NIHR (MC_PC_19056), by the Department of Health and Social Care (DHSC), UKRI, and NIHR COVID-19 Rapid Response Grant (COV19-RECPLA), and by core funding provided by NIHR Oxford Biomedical Research Centre, the Wellcome Trust, the Bill & Melinda Gates Foundation, the Department for International Development, Health Data Research UK, the Medical Research Council Population Health Research Unit, the NIHR Health Protection Unit in Emerging and Zoonotic Infections, NHS Blood and Transplant Research and Development Funding, EU's Horizon 2020 research and innovation programme (SUPPORT-E - 101015756), and NIHR Clinical Trials Unit Support Funding. TJ is supported by a grant from UK Medical Research Council (MC_UU_0002/14) and an NIHR Senior Research Fellowship (NIHR-SRF-2015-08-001). WSL is supported by core funding provided by NIHR Nottingham Biomedical Research Centre. AbbVie contributed some supplies of lopinavir–ritonavir for use in this trial. Tocilizumab was provided free of charge for this trial by Roche. REGN-COV2 was provided free of charge for this trial by Regeneron. The collection of plasma was funded by the DHSC through core funding and funding under COVID-19 and EU SoHo Grant. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR, NHS Blood and Transplant, the DHSC, or the EU.

Publisher Copyright:
© 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license

ASJC Scopus subject areas

  • Medicine(all)

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