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<jats:title>ABSTRACT</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Treatment of COVID-19 patients with plasma containing anti-SARS-CoV-2 antibodies may have a beneficial effect on clinical outcomes. We aimed to evaluate the safety and efficacy of convalescent plasma in patients admitted to hospital with COVID-19.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>In this randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]) several possible treatments are being compared with usual care in patients hospitalised with COVID-19 in the UK. Eligible and consenting patients were randomly allocated to receive either usual care plus high titre convalescent plasma or usual care alone. The primary outcome was 28-day mortality.</jats:p></jats:sec><jats:sec><jats:title>Findings</jats:title><jats:p>Between 28 May 2020 and 15 January 2021, 5795 patients were randomly allocated to receive convalescent plasma and 5763 to usual care alone. There was no significant difference in 28-day mortality between the two groups: 1398 (24%) of 5795 patients allocated convalescent plasma and 1408 (24%) of 5763 patients allocated usual care died within 28 days (rate ratio [RR] 1·00; 95% confidence interval [CI] 0·93 to 1·07; p=0·93). 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 (66% <jats:italic>vs</jats:italic>. 67%; rate ratio 0·98; 95% CI 0·94-1·03, p=0·50). Among those not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion meeting the composite endpoint of progression to invasive mechanical ventilation or death (28% <jats:italic>vs</jats:italic>. 29%; rate ratio 0·99; 95% CI 0·93-1·05, p=0·79).</jats:p></jats:sec><jats:sec><jats:title>Interpretation</jats:title><jats:p>Among patients hospitalised with COVID-19, high-titre convalescent plasma did not improve survival or other prespecified clinical outcomes.</jats:p></jats:sec><jats:sec><jats:title>Funding</jats:title><jats:p>UK Research and Innovation (Medical Research Council) and National Institute of Health Research (Grant refs: MC_PC_19056; COV19-RECPLA).</jats:p></jats:sec>

Original publication

DOI

10.1101/2021.03.09.21252736

Type

Journal article

Publisher

Cold Spring Harbor Laboratory

Publication Date

10/03/2021