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Aspirin in Patients Admitted to Hospital with COVID-19 (RECOVERY): a Randomised, Controlled, Open-Label, Platform Trial

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Aspirin in Patients Admitted to Hospital with COVID-19 (RECOVERY): a Randomised, Controlled, Open-Label, Platform Trial medRxiv preprint doi: https://doi.org/10.1101/2021.06.08.21258132; this version posted June 8, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license . Aspirin for COVID-19 1 2 3 Aspirin in patients admitted to hospital with 4 COVID-19 (RECOVERY): a randomised, controlled, 5 open-label, platform trial 6 7 Running title: Aspirin for COVID-19 8 9 RECOVERY Collaborative Group* 10 11 12 *The writing committee and trial steering committee are listed at the end of this 13 manuscript and a complete list of collaborators in the Randomised Evaluation of 14 COVID-19 Therapy (RECOVERY) trial is provided in the Supplementary Appendix. 15 16 Correspondence to: Prof Peter W Horby and Prof Martin J Landray, RECOVERY Central 17 Coordinating Office, Richard Doll Building, Old Road Campus, Roosevelt Drive, Oxford OX3 18 7LF, United Kingdom. 19 Email: [email protected] 20 21 Word count: 22 Abstract – 301 words 23 Main text – 3085 words 24 References – 33 25 Tables & Figures – 2 + 3 26 27 NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice. 1 medRxiv preprint doi: https://doi.org/10.1101/2021.06.08.21258132; this version posted June 8, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license . Aspirin for COVID-19 28 SUMMARY 29 Background: Aspirin has been proposed as a treatment for COVID-19 on the basis 30 of its antithrombotic properties. 31 Methods: In this randomised, controlled, open-label platform trial, several possible 32 treatments were compared with usual care in patients hospitalised with COVID-19. 33 Eligible and consenting adults were randomly allocated in a 1:1 ratio to either usual 34 standard of care plus 150mg aspirin once daily until discharge or usual standard of 35 care alone using web-based simple (unstratified) randomisation with allocation 36 concealment. The primary outcome was 28-day mortality. The trial is registered with 37 ISRCTN (50189673) and clinicaltrials.gov (NCT04381936). 38 Findings: Between 01 November 2020 and 21 March 2021, 7351 patients were 39 randomly allocated to receive aspirin and 7541 patients to receive usual care alone. 40 Overall, 1222 (17%) patients allocated to aspirin and 1299 (17%) patients allocated to 41 usual care died within 28 days (rate ratio 0·96; 95% confidence interval [CI] 0·89-1·04; 42 p=0·35). Consistent results were seen in all pre-specified subgroups of patients. 43 Patients allocated to aspirin had a slightly shorter duration of hospitalisation (median 44 8 vs. 9 days) and a higher proportion were discharged from hospital alive within 28 45 days (75% vs. 74%; rate ratio 1·06; 95% CI 1·02-1·10; p=0·0062). Among those not 46 on invasive mechanical ventilation at baseline, there was no significant difference in 47 the proportion meeting the composite endpoint of invasive mechanical ventilation or 48 death (21% vs. 22%; risk ratio 0·96; 95% CI 0·90-1·03; p=0·23). Aspirin use was 49 associated with an absolute reduction in thrombotic events of 0.6% (SE 0.4%) and an 50 absolute increase in major bleeding events of 0.6% (SE 0.2%). 2 medRxiv preprint doi: https://doi.org/10.1101/2021.06.08.21258132; this version posted June 8, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license . Aspirin for COVID-19 51 Interpretation: In patients hospitalised with COVID-19, aspirin was not associated 52 with reductions in 28-day mortality or in the risk of progressing to invasive mechanical 53 ventilation or death but was associated with a small increase in the rate of being 54 discharged alive within 28 days. 55 Funding: UK Research and Innovation (Medical Research Council), National Institute 56 of Health Research (Grant ref: MC_PC_19056), and the Wellcome Trust (Grant Ref: 57 222406/Z/20/Z) through the COVID-19 Therapeutics Accelerator. 58 Keywords: COVID-19, aspirin, clinical trial. 59 3 medRxiv preprint doi: https://doi.org/10.1101/2021.06.08.21258132; this version posted June 8, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license . Aspirin for COVID-19 60 INTRODUCTION 61 Thrombosis is a key feature of severe COVID-19, with 5-30% of hospitalised patients 62 (depending on illness severity) experiencing a major venous thromboembolic event 63 (mostly pulmonary embolism) and up to 3% an arterial thromboembolic event, 64 particularly myocardial infarction and ischaemic stroke.1,2 The risk of thromboembolic 65 complications is reported to be higher in COVID-19 than in other acute medical 66 illnesses and viral respiratory infections, and is associated with worse prognosis.3,4 67 Antiplatelet therapy may have beneficial effects in severe COVID-19 through several 68 mechanisms including inhibition of platelet aggregation, reduction of platelet-derived 69 inflammation, and blocking thrombogenic neutrophil extracellular traps and 70 disseminated intravascular coagulation.5 Aspirin is an affordable, globally available 71 drug which at low doses irreversibly inhibits the COX-1 enzyme which is responsible 72 for production of thromboxane A2 and pro-inflammatory prostaglandins. Aspirin can 73 reduce both arterial and venous thrombotic events and has been shown to abolish in- 74 vitro hyperactivity in platelets from SARS-CoV-2 infected patients.6,7 Existing 75 randomized evidence has shown that 75-150mg aspirin daily is as effective as higher 76 doses in preventing cardiovascular events.6 77 Seven clinical trials of aspirin in COVID-19 are registered but none have yet reported 78 on the effect of aspirin therapy in COVID-19. Here we report the results of a large 79 randomised controlled trial of aspirin in patients hospitalised with COVID-19. 80 81 METHODS 4 medRxiv preprint doi: https://doi.org/10.1101/2021.06.08.21258132; this version posted June 8, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license . Aspirin for COVID-19 82 Study design and participants 83 The Randomised Evaluation of COVID-19 therapy (RECOVERY) trial is an 84 investigator-initiated, individually randomised, controlled, open-label, platform trial to 85 evaluate the effects of potential treatments in patients hospitalised with COVID-19. 86 Details of the trial design and results for other treatments evaluated (lopinavir-ritonavir, 87 hydroxychloroquine, dexamethasone, azithromycin, tocilizumab, convalescent 88 plasma, and colchicine) have been published previously.8-14 The trial is underway at 89 177 hospitals in the United Kingdom, two hospitals in Indonesia, and two hospitals in 90 Nepal (appendix pp 5-25), supported in the UK by the National Institute for Health 91 Research Clinical Research Network. The trial is coordinated by the Nuffield 92 Department of Population Health at the University of Oxford (Oxford, UK), the trial 93 sponsor. The trial is conducted in accordance with the principles of the International 94 Conference on Harmonisation–Good Clinical Practice guidelines and approved by the 95 UK Medicines and Healthcare products Regulatory Agency (MHRA) and the 96 Cambridge East Research Ethics Committee (ref: 20/EE/0101). The protocol, 97 statistical analysis plan, and additional information are available on the study website 98 www.recoverytrial.net. 99 Patients admitted to hospital were eligible for the trial if they had clinically suspected 100 or laboratory confirmed SARS-CoV-2 infection and no medical history that might, in 101 the opinion of the attending clinician, put the patient at significant risk if they were to 102 participate in the trial. Children aged <18 years were not eligible for randomisation to 103 aspirin. Patients with known hypersensitivity to aspirin, a recent history of major 104 bleeding, or currently receiving aspirin or another antiplatelet treatment were 5 medRxiv preprint doi: https://doi.org/10.1101/2021.06.08.21258132; this version posted June 8, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license . Aspirin for COVID-19 105 excluded. Written informed consent was obtained from all patients, or a legal 106 representative if they were too unwell or unable to provide consent. 107 Randomisation and masking 108 Baseline data were collected using a web-based case report form that included 109 demographics, level of respiratory support, major comorbidities, suitability of the study 110 treatment for a particular patient, and treatment availability at the study site (appendix 111 p33-34). Eligible and consenting adult patients were assigned in a 1:1 ratio to either 112 usual standard of care or usual standard of care plus aspirin using web-based simple 113 (unstratified) randomisation with allocation concealed until after randomisation 114 (appendix p30).
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