| Study characteristics |
| Methods |
Trial design: Bayesian, adaptive, open‐label randomised platform trial Type of publication: journal publication Setting: hospitalised patients Recruitment dates: 30 October 2020 to 23 June 2021 for the first publication, follow‐up until 2 March 2022 Country: Canada, France, Germany, India, Italy, Nepal, the Netherlands, the UK Language: English Number of centres: 105 -
Platform inclusion criteria
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Antiplatelet therapy domain‐specific inclusion criteria
COVID‐19 infection is suspected by the treating clinician or has been confirmed by microbiological testing Microbiological testing for SARS‐CoV‐2 of upper or lower respiratory tract sections or both has occurred or is intended to occur
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Platform exclusion criteria
Death is imminent and inevitable within the next 24 hours AND one or more of the patient, the surrogate decision maker, or the attending physician are not committed to full active treatment Patient is expected to be discharged from hospital today or tomorrow More than two weeks have elapsed while admitted to hospital with symptoms of an acute illness due to suspected or proven COVID‐19 infection Previous participation in REMAP within the last 90 days
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Antiplatelet therapy domain‐specific exclusion criteria
More than 48 hours has elapsed since ICU admission Clinical or laboratory bleeding risk or both that is sufficient to contraindicate antiplatelet therapy Patient is already receiving antiplatelet therapy OR NSAID (non‐steroidal anti‐inflammatory drug) or a clinical decision has been made to commence antiplatelet or NSAID therapy Enrolment in a trial evaluating anticoagulation or antiplatelet therapy for proven or suspected COVID‐19 infection, where the protocol of that trial requires continuation of the treatment assignment specified in that trial Patients older than 75 years AND otherwise eligible for the therapeutic anticoagulation domain Creatinine clearance < 30 mL/min, or receiving renal replacement therapy or extracorporeal membrane oxygenation (ECMO) The treating clinicians believe that participation in the domain would not be in the best interests of the patient Known hypersensitivity to an agent specified as an intervention in this domain will exclude a patient from receiving that agent Known or suspected pregnancy will result in exclusion from the P2Y12 inhibitor intervention Administration or intention to administer lopinavir/ritonavir will result in exclusion from the P2Y12 inhibitor intervention at sites that are using clopidogrel and ticagrelor as the P2Y12 inhibitor
Trial registration number: NCT02735707 Date of trial registration: 13 April 2016 (study was already designed before COVID‐19 became relevant) |
| Participants |
Age: median age (IQR) 57.0 years Gender: 33.4 % female Ethnicity: Asian 11.2 %, Black 3.2 %, Mixed 2.7%, White 77.3%, Other 5.5% Number of participants (recruited/allocated/evaluated): 6775/1824/1795 97% (1370 of 1411) in the critically ill and 98% (237 of 241) in non‐critically ill participants with confirmed COVID‐19 were evaluated, for the 180‐day publication only the initially critically ill were evaluated -
Severity of disease: acute illness due to suspected or proven COVID‐19; divided into critically ill or non‐critically ill group
Critically ill: patients admitted to an ICU and receiving respiratory organ support (invasive or noninvasive mechanical ventilation including via high‐flow nasal cannula if the flow rate was at least 30 L/min and the fraction of inspired oxygen was at least 0.4) or cardiovascular organ support (receipt of vasopressors or inotropes), n = 1532 Non‐critically ill: all others, n = 263
Additional diagnoses: diabetes 21.9%, respiratory disease 18.8%, kidney disease 3.5%, severe cardiovascular disease 4.0%, any immunosuppressive condition 4.0% Previous treatments within 48 h of recruitment: steroids 97.0%, remdesivir 21.9%, tocilizumab 38.7%, sarilumab 9.3%, low molecular weight heparin/unfractionated heparin/direct oral anticoagulants in different dosing |
| Interventions |
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| Outcomes |
Primary outcomes: organ support‐free days to day 21, survival to hospital discharge
Secondary outcomes: 90‐day mortality, progression to intubation, ECMO or death, days free from organ support (respiratory, cardiovascular), length of stay in the hospital, hospital mortality, death or major thrombotic events, major bleeding, serious adverse events, etc. |
| Notes |
Sponsor: the Platform for European Preparedness Against (Re‐)Emerging Epidemics (PREPARE) consortium of the European Union, FP7‐HEALTH‐2013‐INNOVATION‐1 (grant 602525), the Rapid European COVID‐19 Emergency Research Response (RECOVER) consortium of the European Union’s Horizon 2020 Research and Innovation Programme (grant 101003589), the Australian National Health and Medical Research Council (grant APP1101719), the Health Research Council of New Zealand (grant 16/631), the Canadian Institute of Health Research Strategy for Patient‐Oriented Research Innovative Clinical Trials Program (grant 158584), the NIHR and the NIHR Imperial Biomedical Research Centre, the Health Research Board of Ireland (grant CTN 2014‐012), the University of Pittsburgh Medical Center (UPMC) Learning While Doing Program, the Translational Breast Cancer Research Consortium, the French Ministry of Health (grant PHRC‐20‐0147), the Minderoo Foundation, and the Wellcome Trust Innovations Project (grant 215522). Dr Shankar‐Hari is funded by an NIHR clinician scientist fellowship (grant CS‐2016‐16‐011) and Dr Gordon is funded by an NIHR research professorship (grant RP‐2015‐06‐18).
19 authors had pharmaceutical grants |
