Aspirin in patients admitted to hospital with COVID-19 (RECOVERY) : a randomised, controlled, open-label, platform trial
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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.
RECOVERY Collaborative Group & Dhasmana , D J 2022 , ' Aspirin in patients admitted to hospital with COVID-19 (RECOVERY) : a randomised, controlled, open-label, platform trial ' , Lancet , vol. 399 , no. 10320 , pp. 143-151 . https://doi.org/10.1016/S0140-6736(21)01825-0
Copyright © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license.
DescriptionThe 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.
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