NCT04409834.

Study name	A multicenter, randomized‐controlled trial to evaluate the efficacy and safety of antithrombotic therapy for prevention of arterial and venous thrombotic complications in critically‐ill COVID‐19 patients
Starting date	5 August 2020
Contact information	Vivian Baird‐Zars Brigham and Women's Hospital Boston, Massachusetts, USA, 02459 800‐385‐4444 | vbaird-zars@bwh.harvard.edu
Methods	Multicentre, open‐label, parallel‐assignment RCT
Participants	750 participants, ≥ 18 years, female and male Inclusion criteria: Age ≥18 years (male or female) Acute infection with SARS‐CoV2 Currently admitted to ICU Exclusion criteria: Ongoing (> 48 h) or planned full‐dose (therapeutic) anticoagulation for any indication Ongoing or planned treatment with dual antiplatelet therapy Contraindication to antithrombotic therapy or high risk of bleeding due to conditions including, but not limited to, any of the following: history of intracranial haemorrhage, known CNS tumour or CNS vascular abnormality active or recent major bleeding within the past 30 days with untreated source platelet count < 70,000 or known functional platelet disorder fibrinogen < 200 mg/dL INR > 1.9 History of HIT Ischemic stroke within the past 2 weeks Patients who meet the following criterion are excluded from the second randomisation (antiplatelet therapy vs no antiplatelet therapy): Ongoing or planned antiplatelet therapy, including aspirin monotherapy
Interventions	Experimental Full‐dose anticoagulation + antiplatelet therapy Full‐dose anticoagulation: UFH IV continuous targeting aPTT of 1.5‐2.5 times control, or enoxaparin 1 mg/kg SC every 12 h Anti‐platelet therapy: clopidogrel 300 mg oral x 1, followed by clopidogrel 75 mg oral once daily Full‐dose anticoagulation + no antiplatelet therapy Full‐dose anticoagulation: UFH IV continuous targeting aPTT of 1.5‐2.5 times control, or enoxaparin 1 mg/kg SC every 12 h Prophylactic anticoagulation + antiplatelet therapy Standard prophylactic anticoagulation: enoxaparin 40 mg SC once daily or UFH 5000 IU SC three times/d Antiplatelet therapy: clopidogrel 300 mg oral x1, followed by clopidogrel 75 mg oral once daily Comparator Prophylactic anticoagulation + no antiplatelet therapy Standard prophylactic anticoagulation: enoxaparin 40 mg SC once daily or UFH 5000 IU SC three times/d
Outcomes	Primary Primary endpoint: venous or arterial thrombotic events (time frame: 28 days or until hospital discharge, whichever earlier) Secondary Key secondary endpoint: clinically evident venous or arterial thrombotic events (time frame: 28 days or until hospital discharge, whichever earlier)
Notes	NCT04409834 | No data provided