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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
The Lancet, Volume 397, No. 10274, Year 2021
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Description
Background: Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunomodulatory actions. We aimed to evaluate the safety and efficacy of azithromycin in patients admitted to hospital with COVID-19. Methods: In this randomised, controlled, open-label, adaptive platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), several possible treatments were compared with usual care in patients admitted to hospital with COVID-19 in the UK. The trial is underway at 176 hospitals in the UK. Eligible and consenting patients were randomly allocated to either usual standard of care alone or usual standard of care plus azithromycin 500 mg once per day by mouth or intravenously for 10 days or until discharge (or allocation to one of the other RECOVERY treatment groups). Patients were assigned via web-based simple (unstratified) randomisation with allocation concealment and were twice as likely to be randomly assigned to usual care than to any of the active treatment groups. Participants and local study staff were not masked to the allocated treatment, but all others involved in the trial were masked to the outcome data during the trial. The primary outcome was 28-day all-cause mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936. Findings: Between April 7 and Nov 27, 2020, of 16 442 patients enrolled in the RECOVERY trial, 9433 (57%) were eligible and 7763 were included in the assessment of azithromycin. The mean age of these study participants was 65·3 years (SD 15·7) and approximately a third were women (2944 [38%] of 7763). 2582 patients were randomly allocated to receive azithromycin and 5181 patients were randomly allocated to usual care alone. Overall, 561 (22%) patients allocated to azithromycin and 1162 (22%) patients allocated to usual care died within 28 days (rate ratio 0·97, 95% CI 0·87–1·07; p=0·50). No significant difference was seen in duration of hospital stay (median 10 days [IQR 5 to >28] vs 11 days [5 to >28]) or the proportion of patients discharged from hospital alive within 28 days (rate ratio 1·04, 95% CI 0·98–1·10; p=0·19). Among those not on invasive mechanical ventilation at baseline, no significant difference was seen in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (risk ratio 0·95, 95% CI 0·87–1·03; p=0·24). Interpretation: In patients admitted to hospital with COVID-19, azithromycin did not improve survival or other prespecified clinical outcomes. Azithromycin use in patients admitted to hospital with COVID-19 should be restricted to patients in whom there is a clear antimicrobial indication. Funding: UK Research and Innovation (Medical Research Council) and National Institute of Health Research. © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license
Authors & Co-Authors
Abdul-Kadir, Rezan
Unknown Affiliation
Adam, Matthew
Unknown Affiliation
Adams, Katherine
Unknown Affiliation
Agbeko, Rachel Sarah
Unknown Affiliation
Ahmed, Muhammad S.
Unknown Affiliation
Ahmed, Osama Abdelhakim Aly
Unknown Affiliation
Akhtar, Nasim
Unknown Affiliation
Alexander, Alison
Unknown Affiliation
Alexander, John H.P.
Unknown Affiliation
Ali, Mohammad Rizwan
Unknown Affiliation
Ali, Syed Danish
Unknown Affiliation
Allen, Sam H.
Unknown Affiliation
Anderson, Laura N.
Unknown Affiliation
Aramburo, Àngela
Unknown Affiliation
Ashraf, Muhammad Zubair
Unknown Affiliation
Babiker, Babiker Ahmed
Unknown Affiliation
Baillie, Kenneth J.
Unknown Affiliation
Baird, Yolanda
Unknown Affiliation
Bakerly, Nawar Diar
Unknown Affiliation
Balasubramaniam, Madhu Shankar
Unknown Affiliation
Ball, Ceri
Unknown Affiliation
Bamford, A. R.J.
Unknown Affiliation
Bandi, Srini
Unknown Affiliation
Barlow, Gavin D.
Unknown Affiliation
Barnacle, James R.
Unknown Affiliation
Barnett-Vanes, Ashton
Unknown Affiliation
Barr, David Adam
Unknown Affiliation
Bayes, Hannah Kelly
Unknown Affiliation
Bazaz, Rohit
Unknown Affiliation
Bell, Louise V.
Unknown Affiliation
Bernatoniene, Jolanta
Unknown Affiliation
Berriman, Thomas
Unknown Affiliation
Beynon, Fenella
Unknown Affiliation
Bhagani, Sanjay R.
Unknown Affiliation
Bicanic, Tihana A.
Unknown Affiliation
Bikov, Andras
Unknown Affiliation
Black, Mairead E.
Unknown Affiliation
Blazeby, Jane M.
Unknown Affiliation
Blencowe, Natalie S.
Unknown Affiliation
Boffito, Marta A.
Unknown Affiliation
Bokhandi, Sumit S.
Unknown Affiliation
Bowman, Louise J.
Unknown Affiliation
Boyles, Louise
Unknown Affiliation
Brightling, Christopher Edward
Unknown Affiliation
Brown, Louise Clare
Unknown Affiliation
Brown, Robert Clark
Unknown Affiliation
Brown, Steven Ross
Unknown Affiliation
Brown, Tom
Unknown Affiliation
Brunskill, N. J.
Unknown Affiliation
Buch, Maya Hema
Unknown Affiliation
Buchanan, Ruaridh
Unknown Affiliation
Burden, Christy A.
Unknown Affiliation
Burden, Tom G.
Unknown Affiliation
Burns, Karen E.A.
Unknown Affiliation
Calderwood, Claire J.
Unknown Affiliation
Calisti, Giorgio
Unknown Affiliation
Camm, Christian Fielder
Unknown Affiliation
Campbell, Jonathon R.
Unknown Affiliation
Camsooksai, Julie
Unknown Affiliation
Capp, Angelika
Unknown Affiliation
Carley, Simon David
Unknown Affiliation
Chadwick, David Robert
Unknown Affiliation
Chalmers, James D.
Unknown Affiliation
Chan, Carmen S.Michael
Unknown Affiliation
Chan, Xin Hui S.
Unknown Affiliation
Chappell, Lucy C.
Unknown Affiliation
Chaudhuri, Nazia
Unknown Affiliation
Cheaveau, James
Unknown Affiliation
Chitalia, Nihil
Unknown Affiliation
Churchill, David N.
Unknown Affiliation
Cicconi, Paola
Unknown Affiliation
Clark, Patricia M.
Unknown Affiliation
Clark, Thomas A.
Unknown Affiliation
Clarke, Paul
Unknown Affiliation
Clarke, Robert J.
Unknown Affiliation
Cohen, Daniëlle
Unknown Affiliation
Cole, Jade M.
Unknown Affiliation
Cole, Nicholas I.
Unknown Affiliation
Collini, Paul J.
Unknown Affiliation
Collins, Emma L.
Unknown Affiliation
Cooke, Graham S.
Unknown Affiliation
Cooper, Jamie Gray
Unknown Affiliation
Statistics
Citations: 199
Authors: 82
Identifiers
Doi:
10.1016/S0140-6736(21)00149-5
ISSN:
01406736
Research Areas
Covid
Health System And Policy
Study Design
Cross Sectional Study
Participants Gender
Female