期刊
LANCET
卷 397, 期 10289, 页码 2049-2059出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/S0140-6736(21)00897-7
关键词
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资金
- NHS Blood and Transplant
- Scottish National Blood Transfusion Service
- Welsh Blood Service
- Northern Ireland Blood Transfusion Service
- Public Health England
- Department of Health Social Care
- ntensive Care National Audit & Research Centre
- Public Health Scotland
- National Records Service of Scotland
- UK Research and Innovation (UKRI)
- NIHR [MC_PC_19056]
- Department of Health and Social Care (DHSC)
- UKRI
- NIHR COVID-19 Rapid Response Grant (COV19-RECPLA)
- NIHR Oxford Biomedical Research Centre
- Wellcome Trust
- Bill & Melinda Gates Foundation
- Department for International Development, Health Data Research UK
- Medical Research Council Population Health Research Unit
- 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]
- UK Medical Research Council [MC_UU_0002/14]
- NIHR Senior Research Fellowship [NIHR-SRF-2015-08-001]
- NIHR Nottingham Biomedical Research Centre
- DHSC
- EU SoHo Grant
- NIHR Clinical Trials Unit Support Funding
- NHS DigiTrials
Convalescent plasma therapy did not improve survival or other clinical outcomes in hospitalized COVID-19 patients.
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. Copyright (C) 2021 The Author(s). Published by Elsevier Ltd.
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