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

Abani, Obbina; Abbas, Ali; Abbas, Fatima; Abbas, Mustafa; Abbasi, Sadia; Abbass, Hakam; Abbott, Alfie; Abdallah, Nabeel; Abdelaziz, Ashraf; Abdelfattah, Mohamed; Abdelqader, Bushra; Abdo, David; Abdul, Basir; Abdul Rasheed, Althaf; Abdulakeem, Ajibode; Abdul-Kadir, Rezan; Abdulle, Amina; Abdulmumeen, Abdulfatahi; Abdul-Raheem, Rasheed; Abdulshukkoor, Niyaz; Abdusamad, Kula; Abed El Khaleq, Yazeed; Abedalla, Mai; Abeer Ul Amna, Abeer Ul Amna; Abernethy, Katrina; Aboaba, Adebanke; Abo-Leyah, Hani; Abou-Haggar, Ahmed; Abouibrahim, Mahmoud; Abraham, Miriam; Abraham, Tizzy; Abraheem, Abraheem; Abrams, Judith; Abu, Hyacinth-John; Abu-Arafeh, Ahmed; Abubacker, Syed M; Abung, Akata; Aceampong, Yaa; Achara, Amaka; Acharya, Devikumar; Acheampong, Sarah; Acheson, Janet; Acosta, Andres; Acton, Catherine; Adabie-Ankrah, Jacqueline; Adair, Sara; Adam, Fiona; Adam, Matthew; Adamali, Huzaifa; Adams, Carol; Adams, Charlotte; Adams, Kate; Adams, Lisa; Adams, Richard; Adams, Tim; Adcock, Kirsty; Addai, J...

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.

Citation

Abani, O., Abbas, A., Abbas, F., Abbas, M., Abbasi, S., Abbass, H., …Zyengi, S. (2021). Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial. Lancet, 397(10289), 2049-2059. https://doi.org/10.1016/s0140-6736%2821%2900897-7

• Journal Article Type: Article
• Acceptance Date: Apr 12, 2021
• Online Publication Date: May 14, 2021
• Publication Date: May 29, 2021
• Deposit Date: Aug 3, 2021
• Publicly Available Date: Aug 3, 2021
• Journal: The Lancet
• Print ISSN: 0140-6736
• Electronic ISSN: 1474-547X
• Publisher: Elsevier BV
• Peer Reviewed: Peer Reviewed
• Volume: 397
• Issue: 10289
• Pages: 2049-2059
• DOI: https://doi.org/10.1016/s0140-6736%2821%2900897-7
• Keywords: General Medicine
• Public URL: https://nottingham-repository.worktribe.com/output/5943713
• Publisher URL: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00897-7/fulltext
• Additional Information: Authors on behalf of RECOVERY Collaborative Group. ; ; University of Nottingham authors: Ed Juszczak, Alan Montgomery. Fellow linked author, Lim Wei Shen.