Abstract
SummaryBackgroundAspirin 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.MethodsIn 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).FindingsBetween 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%).InterpretationIn 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.FundingUK Research and Innovation (Medical Research Council), National Institute of Health Research, and the Wellcome Trust through the COVID-19 Therapeutics Accelerator.
Highlights
Thrombosis is a key feature of severe COVID-19, with 5–30% of hospitalised patients having a major venous thromboembolic event and up to 3% of patients having an arterial thromboembolic event, myocardial infarction and ischaemic stroke.[1,2] The risk of thromboembolic complications is reported to be higher in COVID-19 than in other acute medical illnesses and viral respiratory infections, and is associated with worse prognosis.[3,4]Anti-platelet therapy might have beneficial effects in severe COVID-19 through several mechanisms, including inhibition of platelet aggregation, reduction of plateletderived inflammation, and blocking of thrombogenic neutrophil extracellular traps.[5]
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
Aspirin can reduce both arterial and venous thrombotic events and has been shown to prevent in-vitro hyperactivity in platelets from patients with SARS-CoV-2.6,7 Existing evidence from randomised trials has shown that 75–150 mg aspirin per day is as effective as higher doses in preventing cardiovascular events.[6]
Summary
Anti-platelet therapy might have beneficial effects in severe COVID-19 through several mechanisms, including inhibition of platelet aggregation, reduction of plateletderived inflammation, and blocking of thrombogenic neutrophil extracellular traps.[5] Aspirin is an affordable, globally available drug which at low doses irreversibly inhibits the cyclooxygenase-1 enzyme, which is responsible for production of thromboxane A2 and proinflammatory prostaglandins Aspirin can reduce both arterial and venous thrombotic events and has been shown to prevent in-vitro hyperactivity in platelets from patients with SARS-CoV-2.6,7 Existing evidence from randomised trials has shown that 75–150 mg aspirin per day is as effective as higher doses in preventing cardiovascular events.[6]. We report the results of a large randomised controlled trial of aspirin in patients hospitalised with COVID-19
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