TY - JOUR
T1 - Aspirin in patients admitted to hospital with COVID-19 (RECOVERY)
T2 - a randomised, controlled, open-label, platform trial
AU - RECOVERY Collaborative Group
AU - Abani, Obbina
AU - Abbas, Ali
AU - Abbas, Fatima
AU - Abbas, Mustafa
AU - Abbasi, Sadia
AU - Abbass, Hakam
AU - Abbott, Alfie
AU - Abdallah, Nabeel
AU - Abdelaziz, Ashraf
AU - Abdelfattah, Mohamed
AU - Abdelqader, Bushra
AU - Abdul, Basir
AU - Abdul Rasheed, Althaf
AU - Abdulakeem, Ajibode
AU - Abdul-Kadir, Rezan
AU - Abdullah, Abdullah
AU - Abdulmumeen, Abdulfatahi
AU - Abdul-Raheem, Rasheed
AU - Abdulshukkoor, Niyaz
AU - Abdusamad, Kula
AU - Abed El Khaleq, Yazeed
AU - Abedalla, Mai
AU - Abeer Ul Amna, Abeer Ul Amna
AU - Abernethy, Katrina
AU - Aboaba, Adebanke
AU - Abo-Leyah, Hani
AU - Abou-Haggar, Ahmed
AU - Abouibrahim, Mahmoud
AU - Abraham, Miriam
AU - Abraham, Tizzy
AU - Abraheem, Abraheem
AU - Abrams, Judith
AU - Abu, Hyacinth John
AU - Abu-Arafeh, Ahmed
AU - Abubacker, Syed Mohamed
AU - Abung, Akata
AU - Aceampong, Yaa
AU - Achara, Amaka
AU - Acharya, Devikumar
AU - Acheampong, Sarah
AU - Acheson, Janet
AU - Acosta, Andres
AU - Acton, Catherine
AU - Adabie-Ankrah, Jacqueline
AU - Adam, Fiona
AU - Adam, Matthew
AU - Adamali, Huzaifa
AU - Adams, Carol
AU - Nelwan, Erni
N1 - Funding Information:
Above all, we would like to thank the thousands of patients who participated in this trial. We would also like to thank the many doctors, nurses, pharmacists, other allied health professionals, and research administrators at the participating hospitals in Nepal and Indonesia and at 176 UK National Health Service hospital organisations across the whole of the UK, supported by staff at the National Institute of Health Research (NIHR) Clinical Research Network, NHS DigiTrials, Public Health England, Department of Health and Social Care, the Intensive Care National Audit and Research Centre, Public Health Scotland, National Records Service of Scotland, the Secure Anonymised Information Linkage at the University of Swansea, and the NHS in England, Scotland, Wales, and Northern Ireland. The RECOVERY trial is supported by grants to the University of Oxford from the UK Research and Innovation (UKRI) and the NIHR (grant reference MC_PC_19056), the Department of Health and Social Care (DHSC), UKRI, and NIHR COVID-19 Rapid Response Grant (COV19-RECPLA), and the Wellcome Trust (grant referebce 222406/Z/20/Z) through the COVID-19 Therapeutics Accelerator. Core funding is provided by the NIHR Oxford Biomedical Research Centre, Wellcome, the Bill & Melinda Gates Foundation, the Foreign, Commonwealth, and Development Department, Health Data Research UK, the Medical Research Council Population Health Research Unit, the NIHR Health Protection Unit in Emerging and Zoonotic Infections, and NIHR Clinical Trials Unit Support Funding. TJ is supported by a grant from the UK Medical Research Council (MC_UU_00002/14) and an NIHR Senior Research Fellowship (NIHR-SRF-2015-08-001). WSL is supported by core funding provided by NIHR Nottingham Biomedical Research Centre. Combiphar supplied colchicine free of charge for use in this trial in Indonesia. AbbVie contributed some supplies of lopinavir-ritonavir for use in this trial. Tocilizumab was provided free of charge for this trial by Roche Products. Casivirimab and imdevimab was provided free of charge for this trial by Regeneron. The views expressed in this publication are our own and not necessarily those of the NHS or the NIHR. Writing committee (on behalf of the RECOVERY Collaborative Group), Peter W Horby,* Guilherme Pessoa-Amorim,* Natalie Staplin,* Jonathan R Emberson, Mark Campbell, Enti Spata, Leon Peto, Nigel J Brunskill, Simon Tiberi, Victor Chew, Thomas Brown, Hasan Tahir, Beate Ebert, David Chadwick, Tony Whitehouse, Rahuldeb Sarkar, Clive Graham, J Kenneth Baillie, Buddha Basnyat, Maya H Buch, Lucy C Chappell, Jeremy Day, Saul N Faust, Raph L Hamers, Thomas Jaki, Edmund Juszczak, Katie Jeffery, Wei Shen Lim, Alan Montgomery, Andrew Mumford, Kathryn Rowan, Guy Thwaites, Marion Mafham,? Richard Haynes,? and Martin J Landray?. *PWH, GP-A, and NS contributed equally. ?MM, RH, and MJL contributed equally.
Funding Information:
Above all, we would like to thank the thousands of patients who participated in this trial. We would also like to thank the many doctors, nurses, pharmacists, other allied health professionals, and research administrators at the participating hospitals in Nepal and Indonesia and at 176 UK National Health Service hospital organisations across the whole of the UK, supported by staff at the National Institute of Health Research (NIHR) Clinical Research Network, NHS DigiTrials, Public Health England, Department of Health and Social Care, the Intensive Care National Audit and Research Centre, Public Health Scotland, National Records Service of Scotland, the Secure Anonymised Information Linkage at the University of Swansea, and the NHS in England, Scotland, Wales, and Northern Ireland. The RECOVERY trial is supported by grants to the University of Oxford from the UK Research and Innovation (UKRI) and the NIHR (grant reference MC_PC_19056), the Department of Health and Social Care (DHSC), UKRI, and NIHR COVID-19 Rapid Response Grant (COV19-RECPLA), and the Wellcome Trust (grant referebce 222406/Z/20/Z) through the COVID-19 Therapeutics Accelerator. Core funding is provided by the NIHR Oxford Biomedical Research Centre, Wellcome, the Bill & Melinda Gates Foundation, the Foreign, Commonwealth, and Development Department, Health Data Research UK, the Medical Research Council Population Health Research Unit, the NIHR Health Protection Unit in Emerging and Zoonotic Infections, and NIHR Clinical Trials Unit Support Funding. TJ is supported by a grant from the UK Medical Research Council (MC_UU_00002/14) and an NIHR Senior Research Fellowship (NIHR-SRF-2015-08-001). WSL is supported by core funding provided by NIHR Nottingham Biomedical Research Centre. Combiphar supplied colchicine free of charge for use in this trial in Indonesia. AbbVie contributed some supplies of lopinavir-ritonavir for use in this trial. Tocilizumab was provided free of charge for this trial by Roche Products. Casivirimab and imdevimab was provided free of charge for this trial by Regeneron. The views expressed in this publication are our own and not necessarily those of the NHS or the NIHR.
Publisher Copyright:
© 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license
PY - 2022/1/8
Y1 - 2022/1/8
N2 - Background: Aspirin has been proposed as a treatment for COVID-19 on the basis of its anti-thrombotic properties. We aimed to evaluate the efficacy and safety of aspirin in patients admitted to hospital with COVID-19. Methods: In this randomised, controlled, open-label, platform trial, several possible treatments were compared with usual care in patients hospitalised with COVID-19. The trial took place at 177 hospitals in the UK, two hospitals in Indonesia, and two hospitals in Nepal. Eligible and consenting adults were randomly allocated in a 1:1 ratio to either usual standard of care plus 150 mg aspirin once per day until discharge or usual standard of care alone using web-based simple (unstratified) randomisation with allocation concealment. The primary outcome was 28 day mortality. All analyses were done by intention to treat. The trial is registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936). Findings: Between Nov 1, 2020, and March 21, 2021, 14 892 (66%) of 22 560 patients enrolled into the RECOVERY trial were eligible to be randomly allocated to aspirin. 7351 patients were randomly allocated (1:1) to receive aspirin and 7541 patients to receive usual care alone. Overall, 1222 (17%) of 7351 patients allocated to aspirin and 1299 (17%) of 7541 patients allocated to usual care died within 28 days (rate ratio 0·96, 95% CI 0·89–1·04; p=0·35). Consistent results were seen in all prespecified subgroups of patients. Patients allocated to aspirin had a slightly shorter duration of hospitalisation (median 8 days, IQR 5 to >28, vs 9 days, IQR 5 to >28) and a higher proportion were discharged from hospital alive within 28 days (75% vs 74%; rate ratio 1·06, 95% CI 1·02–1·10; p=0·0062). Among patients not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (21% vs 22%; risk ratio 0·96, 95% CI 0·90–1·03; p=0·23). Aspirin use was associated with a reduction in thrombotic events (4·6% vs 5·3%; absolute reduction 0·6%, SE 0·4%) and an increase in major bleeding events (1·6% vs 1·0%; absolute increase 0·6%, SE 0·2%). Interpretation: In patients hospitalised with COVID-19, aspirin was not associated with reductions in 28 day mortality or in the risk of progressing to invasive mechanical ventilation or death, but was associated with a small increase in the rate of being discharged alive within 28 days. Funding: UK Research and Innovation (Medical Research Council), National Institute of Health Research, and the Wellcome Trust through the COVID-19 Therapeutics Accelerator.
AB - Background: Aspirin has been proposed as a treatment for COVID-19 on the basis of its anti-thrombotic properties. We aimed to evaluate the efficacy and safety of aspirin in patients admitted to hospital with COVID-19. Methods: In this randomised, controlled, open-label, platform trial, several possible treatments were compared with usual care in patients hospitalised with COVID-19. The trial took place at 177 hospitals in the UK, two hospitals in Indonesia, and two hospitals in Nepal. Eligible and consenting adults were randomly allocated in a 1:1 ratio to either usual standard of care plus 150 mg aspirin once per day until discharge or usual standard of care alone using web-based simple (unstratified) randomisation with allocation concealment. The primary outcome was 28 day mortality. All analyses were done by intention to treat. The trial is registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936). Findings: Between Nov 1, 2020, and March 21, 2021, 14 892 (66%) of 22 560 patients enrolled into the RECOVERY trial were eligible to be randomly allocated to aspirin. 7351 patients were randomly allocated (1:1) to receive aspirin and 7541 patients to receive usual care alone. Overall, 1222 (17%) of 7351 patients allocated to aspirin and 1299 (17%) of 7541 patients allocated to usual care died within 28 days (rate ratio 0·96, 95% CI 0·89–1·04; p=0·35). Consistent results were seen in all prespecified subgroups of patients. Patients allocated to aspirin had a slightly shorter duration of hospitalisation (median 8 days, IQR 5 to >28, vs 9 days, IQR 5 to >28) and a higher proportion were discharged from hospital alive within 28 days (75% vs 74%; rate ratio 1·06, 95% CI 1·02–1·10; p=0·0062). Among patients not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (21% vs 22%; risk ratio 0·96, 95% CI 0·90–1·03; p=0·23). Aspirin use was associated with a reduction in thrombotic events (4·6% vs 5·3%; absolute reduction 0·6%, SE 0·4%) and an increase in major bleeding events (1·6% vs 1·0%; absolute increase 0·6%, SE 0·2%). Interpretation: In patients hospitalised with COVID-19, aspirin was not associated with reductions in 28 day mortality or in the risk of progressing to invasive mechanical ventilation or death, but was associated with a small increase in the rate of being discharged alive within 28 days. Funding: UK Research and Innovation (Medical Research Council), National Institute of Health Research, and the Wellcome Trust through the COVID-19 Therapeutics Accelerator.
UR - http://www.scopus.com/inward/record.url?scp=85122294690&partnerID=8YFLogxK
U2 - 10.1016/S0140-6736(21)01825-0
DO - 10.1016/S0140-6736(21)01825-0
M3 - Article
C2 - 34800427
AN - SCOPUS:85122294690
SN - 0140-6736
VL - 399
SP - 143
EP - 151
JO - The Lancet
JF - The Lancet
IS - 10320
ER -