NCT04372589.

Study name	Antithrombotic therapy to ameliorate complications of COVID‐19
Starting date	20 May 2020
Contact information	Ryan Zarychanski University of Manitoba, Canada 204‐787‐2993 | rzarychanski@cancercare.mb.ca
Methods	Multicentre, prospective, open‐label, 1:1. 2‐armed, parallel‐assignment RCT
Participants	3000 participants, ≥ 18 years, female and male Inclusion criteria Patients ≥ 18 years providing (possibly through a substitute decision maker) informed consent who require hospitalisation anticipated to last ≥ 72 h, with microbiologically‐confirmed COVID‐19, enrolled < 72 h of hospital admission or of COVID‐19 confirmation Exclusion criteria Receiving invasive mechanical ventilation Patients for whom the intent is to not use pharmacologic thromboprophylaxis Active bleeding Risk factors for bleeding, including: intracranial surgery or stroke within 3 months; history of intracerebral arteriovenous malformation; cerebral aneurysm or mass lesions of the central nervous system; intracranial malignancy; history of intracranial bleeding; history of bleeding diatheses (e.g. haemophilia); history of gastrointestinal bleeding within previous 3 months; thrombolysis within the previous 7 days; presence of an epidural or spinal catheter; recent major surgery < 14 days; uncontrolled hypertension (SBP > 200 mmHg, DBP > 120 mmHg); other physician‐perceived contraindications to anticoagulation Platelet count < 50 x10^9/L, INR > 2.0, or baseline aPTT > 50 Haemoglobin < 80 g/L (to minimise the likelihood of requiring red blood cell transfusion if potential bleeding were to occur) Acute or subacute bacterial endocarditis History of HIT or other heparin allergy including hypersensitivity Current use of dual antiplatelet therapy Patients with an independent indication for therapeutic anticoagulation Patients in whom imminent demise is anticipated and there is no commitment to active ongoing intervention Pregnancy Anticipated transfer to another hospital that is not a study site within 72 h Enrollment in other studies related to anticoagulation or antiplatelet therapy
Interventions	Experimental: therapeutic heparin Therapeutic anticoagulation for 14 days (or until hospital discharge or liberation from supplemental oxygen > 24 h if previously required, whichever comes first) with heparin, with preference for SC LMWH (enoxaparin preferred, although dalteparin or tinzaparin are also acceptable, as available) if no contraindication is present; alternatively, IV UFH infusion may be used. Comparator: prophylactic anticoagulation Participants will receive usual care of thromboprophylactic dose anticoagulation according to local practice.
Outcomes	Primary Intubation and mortality (time frame: 30 days). The primary endpoint is an ordinal endpoint with 3 possible outcomes based on the worst status of each participant through day 30: no requirement for invasive mechanical ventilation, invasive mechanical ventilation, or death Secondary All‐cause mortality (time frame: 30 days and 90 days) Intubation (time frame: 30 days). Invasive mechanical ventilation Hospital‐free days (time frame: 30 days). Days alive outside of the hospital through 30 days following randomisation ICU‐free days (time frame: 30 days). Number of days alive outside of the ICU through 30 days following randomisation Ventilator‐free days (time frame: 30 days). Number of days alive without the use of a ventilator through 30 days following randomisation Non‐invasive ventilation (time frame: 30 days). The use of non‐invasive mechanical ventilation or high‐flow nasal cannula Organ support‐free days (time frame: 21 days). Number of days alive without the use of vasopressors/inotropes and ventilation (including high‐flow nasal cannula > 30 L/min and FIO2 > 40%) through 21 days following randomisation, ranked with death at anytime during 21 days as ‐1 Myocardial infarction (time frame: 30 days and 90 days) Ischaemic stroke (time frame: 30 days and 90 days) VTE (time frame: 30 days and 90 days) Major bleeding (time frame: Intervention period (maximum 14 days)). As defined by the ISTH HIT (time frame: Intervention period (maximum 14 days)). Laboratory‐confirmed
Notes	NCT04372589 | No data provided