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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Empagliflozin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
The Lancet Diabetes and Endocrinology, Volume 11, No. 12, Year 2023
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Description
Background: Empagliflozin has been proposed as a treatment for COVID-19 on the basis of its anti-inflammatory, metabolic, and haemodynamic effects. The RECOVERY trial aimed to assess its safety and efficacy in patients admitted to hospital with COVID-19. Methods: In the randomised, controlled, open-label RECOVERY trial, several possible treatments are compared with usual care in patients hospitalised with COVID-19. In this analysis, we assess eligible and consenting adults who were randomly allocated in a 1:1 ratio to either usual standard of care alone or usual standard of care plus oral empagliflozin 10 mg once daily for 28 days or until discharge (whichever came first) using web-based simple (unstratified) randomisation with allocation concealment. The primary outcome was 28-day mortality; secondary outcomes were duration of hospitalisation and (among participants not on invasive mechanical ventilation at baseline) the composite of invasive mechanical ventilation or death. On March 3, 2023 the independent data monitoring committee recommended that the investigators review the data and recruitment was consequently stopped on March 7, 2023. The ongoing RECOVERY trial is registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936). Findings: Between July 28, 2021 and March 6, 2023, 4271 patients were randomly allocated to receive either empagliflozin (2113 patients) or usual care alone (2158 patients). Primary and secondary outcome data were known for greater than 99% of randomly assigned patients. Overall, 289 (14%) of 2113 patients allocated to empagliflozin and 307 (14%) of 2158 patients allocated to usual care died within 28 days (rate ratio 0·96 [95% CI 0·82–1·13]; p=0·64). There was no evidence of significant differences in duration of hospitalisation (median 8 days for both groups) or the proportion of patients discharged from hospital alive within 28 days (1678 [79%] in the empagliflozin group vs 1677 [78%] in the usual care group; rate ratio 1·03 [95% CI 0·96–1·10]; p=0·44). Among those not on invasive mechanical ventilation at baseline, there was no evidence of a significant difference in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (338 [16%] of 2084 vs 371 [17%] of 2143; risk ratio 0·95 [95% CI 0·84–1·08]; p=0·44). Two serious adverse events believed to be related to empagliflozin were reported: both were ketosis without acidosis. Interpretation: In adults hospitalised with COVID-19, empagliflozin was not associated with reductions in 28-day mortality, duration of hospital stay, or risk of progressing to invasive mechanical ventilation or death so is not indicated for the treatment of such patients unless there is an established indication due to a different condition such as diabetes. Funding: UK Research and Innovation (Medical Research Council) and National Institute of Health Research (MC_PC_19056), and Wellcome Trust (222406/Z/20/Z). Translations: For the Nepali, Hindi, Indonesian (Bahasa) and Vietnamese translations of the abstract see Supplementary Materials section. © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license
Authors & Co-Authors
Abbas, Ali
Unknown Affiliation
Abbass, Hakam
Unknown Affiliation
Abdelaziz, Ammar M.Y.
Unknown Affiliation
Abdul-Kadir, Rezan
Unknown Affiliation
Abousamra, Ahmed O.S.
Unknown Affiliation
Acquah, Rebecca Ruth
Unknown Affiliation
Adam, Matthew
Unknown Affiliation
Adams, Katherine
Unknown Affiliation
Adriaanse, Marguerite
Unknown Affiliation
Afum-Adjei Awuah, Anthony
Unknown Affiliation
Agasiya, Patrick N.
Unknown Affiliation
Agbeko, Rachel Sarah
Unknown Affiliation
Ahmad, Syed Masroor
Unknown Affiliation
Ahmed, Afshan
Unknown Affiliation
Ahmed, Khalid E.
Unknown Affiliation
Ahmed, Mona
Unknown Affiliation
Ahmed, Osama Abdelhakim Aly
Unknown Affiliation
Aidoo, Charles A.
Unknown Affiliation
Akhtar, Nasim
Unknown Affiliation
Akram, Mohammed
Unknown Affiliation
Al-Abadi, Eslam
Unknown Affiliation
Alexander, Alison
Unknown Affiliation
Alexander, John H.P.
Unknown Affiliation
Alghazawi, Laith Omar Khalaf
Unknown Affiliation
Ali, Mohamed Omer
Unknown Affiliation
Ali, Syed Danish
Unknown Affiliation
Alisjahbana, Bachti
Unknown Affiliation
Alli, Abiola R.
Unknown Affiliation
Allsup, David J.
Unknown Affiliation
Al-Shahi Salman, Rustam
Unknown Affiliation
Amoako-Adusei, Amos
Unknown Affiliation
Amuasi, John Humphrey
Unknown Affiliation
Anderson, Laura N.
Unknown Affiliation
Aribike, Oluwatoyin
Unknown Affiliation
Aryal, Diptesh
Unknown Affiliation
Ashraf, Muhammad Zubair
Unknown Affiliation
Aujayeb, Avinash
Unknown Affiliation
Babiker, Babiker Ahmed
Unknown Affiliation
Badat, Aysha E.
Unknown Affiliation
Baillie, John Kenneth
Unknown Affiliation
Baird, Yolanda
Unknown Affiliation
Bakerly, Nawar Diar
Unknown Affiliation
Balasubramaniam, Madhu Shankar
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
Basnet, Sudha
Unknown Affiliation
Basnyat, Buddha
Unknown Affiliation
Bassford, Christopher R.
Unknown Affiliation
Bastola, Anup
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Bayes, Hannah Kelly
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Bazaz, Rohit
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Bell, Louise V.
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Bernatoniene, Jolanta
Unknown Affiliation
Berriman, Thomas
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Beynon, Fenella
Unknown Affiliation
Bhagani, Sanjay R.
Unknown Affiliation
Bibi, Fatima
Unknown Affiliation
Bicanic, Tihana A.
Unknown Affiliation
Bikov, Andras
Unknown Affiliation
Bisnauthsing, Karen N.
Unknown Affiliation
Bittaye, Mustapha
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
Bolger, Clare
Unknown Affiliation
Bonaconsa, Candice
Unknown Affiliation
Bonney, Joseph
Unknown Affiliation
Bousfield, Rachel
Unknown Affiliation
Bowman, Louise J.
Unknown Affiliation
Boyles, Louise
Unknown Affiliation
Brightling, Christopher Edward
Unknown Affiliation
Brown, Elizabeth R.
Unknown Affiliation
Brown, Louise Clare
Unknown Affiliation
Brown, Nicola
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
Buckland, Matthew S.
Unknown Affiliation
Burden, Christy A.
Unknown Affiliation
Burden, Tom G.
Unknown Affiliation
Burhan, Erlina A.
Unknown Affiliation
Burhan, Hassan
Unknown Affiliation
Burke, Kerry A.
Unknown Affiliation
Burns, Karen E.A.
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
Carlin, Ffion E.
Unknown Affiliation
Carroll, Paul A.
Unknown Affiliation
Statistics
Citations: 1
Authors: 101
Identifiers
Doi:
10.1016/S2213-8587(23)00253-X
ISSN:
22138587
Research Areas
Covid
Health System And Policy
Noncommunicable Diseases