| Study characteristics |
| Methods |
Trial design: open‐label, phase 2 + 3 RCT Type of publication: journal article Setting: hospitalised participants Recruitment dates: 1 November 2020 to 21 March 2021 Country: UK, Indonesia, Nepal Language: English Number of centres: 177 in the UK, 2 in Indonesia, 2 in Nepal Inclusion criteria: hospitalised, SARS‐CoV‐2 infection (clinically suspected or laboratory confirmed) Exclusion criteria: if the attending clinician believes that there is a specific contra‐indication to one of the active drug treatment arms or that the patient should definitely be receiving one of the active drug treatment arms then that arm will not be available for randomisation for that patient, for patients who lack capacity, an advanced directive or behaviour that clearly indicates that they would not wish to participate in the trial would be considered sufficient reason to exclude them from the trial; no medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial Trial registration number: NCT04381936 Date of trial registration: 11 May 2020 |
| Participants |
Age: mean (SD); 59.2 years (SD 14.1) in the intervention group and 59.3 years (SD 14.3) in the control group Gender: 4570 (62%) male in the intervention group and 4631 (61%) in the control group Ethnicity: 5474 (74%, intervention) vs 5655 (75% control) White, 1176 (16%, intervention) vs 1202 (16%, control) Black, Asian and minority, 701 (10%, intervention) vs 684 (9%, control) unknown Number of participants (recruited/allocated/evaluated): 22,560/7351 (aspirin) and 7541 (standard care)/7351 (aspirin) and 7541 (standard care) Severity of disease: moderate to severe Additional diagnoses: diabetes (22% each group), heart disease (11% intervention group vs 10% standard care group), chronic lung disease (19% each group), tuberculosis and HIV (< 0.5% per group), severe liver disease (1% each group), severe kidney impairment (3% each group), any of the above (43% each group) Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): NR Concomitant therapy: use of corticosteroids (94% each group) |
| Interventions |
Drugs: aspirin 150 mg orally once daily until discharge Comparator: standard care, no details reported Concomitant therapy: NR Treatment cross‐overs: only 6587 (90%) participants in the intervention group received at least one dose of aspirin and 210 (3%) participants in the control group received at least one dose of aspirin. Duration of follow‐up: 28 days Compliance with assigned treatment: only 5040 (77%) participants in the intervention group took their allocated medication most days following randomisation SARS‐CoV‐2 test result: positive 97% (each group), negative 1% (each group), unknown 2% (each group), number of PCR‐positive unknown |
| Outcomes |
Primary outcome
All‐cause mortality
Secondary outcomes
Duration of hospital stay; median time to being discharged alive, discharged from hospital within 28 days Receipt of invasive mechanical ventilation or death Invasive mechanical ventilation
Additional outcomes
Need for (and duration of) ventilation Need for non‐invasive ventilation Need for renal replacement Successful cessation of invasive mechanical ventilation Number of patients who had thrombotic events Major bleeding events Major cardiac arrhythmias
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| Notes |
Sponsor/funding: UK Research and Innovation (Medical Research Council), National Institute of Health Research, and the Wellcome Trust through the COVID‐19 Therapeutics Accelerator COIs: the authors report no COI Other: NR |
