Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial
Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial
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.
2049-2059
Horby, Peter W.
8f921e75-4605-4fb8-bb2c-be66fac6bb96
Landray, Martin J
17f12752-a8b1-4edc-bc93-690a5e7d7a01
Escourt, L
51673f5b-d328-4da6-818d-893ca9c6e779
Faust, Saul
f97df780-9f9b-418e-b349-7adf63e150c1
Fletcher, Sophie
71599088-9df7-4d4a-8570-aef773ead0fe
RECOVERY Collaborative Group
29 May 2021
Horby, Peter W.
8f921e75-4605-4fb8-bb2c-be66fac6bb96
Landray, Martin J
17f12752-a8b1-4edc-bc93-690a5e7d7a01
Escourt, L
51673f5b-d328-4da6-818d-893ca9c6e779
Faust, Saul
f97df780-9f9b-418e-b349-7adf63e150c1
Fletcher, Sophie
71599088-9df7-4d4a-8570-aef773ead0fe
Horby, Peter W., Landray, Martin J and Escourt, L
,
RECOVERY Collaborative Group
(2021)
Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial.
The Lancet, 397 (10289), .
(doi:10.1016/S0140-6736(21)00897-7).
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.
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More information
e-pub ahead of print date: 14 May 2021
Published date: 29 May 2021
Additional Information:
Contributors
This manuscript was initially drafted by the PWH and MJL, further
developed by the Writing Committee, and approved by all members of
the trial steering committee. PWH and MJL vouch for the data and
analyses, and for the fidelity of this report to the trial protocol and data
analysis plan. PWH, LE, LP, MM, JKB, LCC, SNF, TJ, KJ, WSL, AM, KR,
EJ, DJR, RH, and MJL designed the trial and trial protocol. MM, AR,
GP-A, NJB, TG, DZ, ST, NNA, AU, JW, GK, TB, SS, RH, the Data
Linkage team at the RECOVERY Coordinating Centre, and the health
records and local clinical centre staff listed in the appendix collected the
data. ES, NS, and JRE did the statistical analysis. LE, DJR, and the blood
and transfusion service staff listed in the appendix coordinated the
collection and supply of convalescent plasma. All authors contributed to
data interpretation and critical review and revision of the manuscript.
PWH and MJL had access to the trial data and had final responsibility for
the decision to submit for publication
Identifiers
Local EPrints ID: 456617
URI: http://eprints.soton.ac.uk/id/eprint/456617
ISSN: 0140-6736
PURE UUID: cdc460e6-21be-40cc-8fad-c5f993de9422
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Date deposited: 05 May 2022 16:55
Last modified: 21 Sep 2024 02:15
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Contributors
Author:
Peter W. Horby
Author:
Martin J Landray
Author:
L Escourt
Author:
Sophie Fletcher
Corporate Author: RECOVERY Collaborative Group
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