NCT04359277.

Study name	A randomized trial of anticoagulation strategies in COVID‐19
Starting date	21 April 2020
Contact information	Jeffrey Berger NYU Langone Health, New York, USA 212‐263‐4004 | PROTECT.COVID19@nyulangone.org
Methods	Open‐label, 2‐armed, parallel‐assignment, RCT
Participants	1000 participants, ≥ 18 years, female and male Inclusion criteria ≥ 18 years Hospitalised patient with a diagnosis of COVID‐19 Elevated D‐dimer within prior 48 h. Definition of elevated D‐dimer is site‐determined Exclusion criteria Meeting alternative indication for higher‐dose anticoagulation Prevalent blood clot at the time of enrolment D‐dimer > 10,000 ng/mL Rapidly rising D‐dimer (change in D‐dimer > 10 x over the prior 48 h) Prior VTE Atrial fibrillation (with a CHADS2 Score > 1*) Renal failure (creatinine clearance < 15 and/or requirement of renal replacement therapies) HIT within 100 days Stroke within 30 days Hemorrhagic stroke (ever) GI bleed within 6 months Platelet count < 100,000 Anemia with a haemoglobin < 9 mg/dL Pregnancy Signs of active bleeding (e.g. a whole blood or PRBC transfusion in the past 30 days) Other high bleeding risk (i.e. trauma, use of dual antiplatelet therapy) Congestive heart failure, hypertension, Age > 75 years Diabetes Prior stroke or TIA symptoms
Interventions	Experimental: higher‐dose anticoagulation Drug: enoxaparin higher dose Enoxaparin in participants with a creatine clearance of > 30 Enoxaparin 1 mg/kg every 12 h SC for weight 50‐150 kg Enoxaparin 0.75 mg/kg every 12 h SC for weight > 150 kg or BMI > 40 UFH IV titrated to a goal antiXa of 0.3‐0.5 unit/mL (may be used as an alternative) For enoxaparin, antiXA testing will be done after fourth injection only for participants with BMI > 40 or weight > 150 kg as per institutional policy Comparator: lower‐dose prophylactic anticoagulation Drug: lower‐dose prophylactic anticoagulation Heparin 5000 units every 12 or every 8 h or 7500 units every 8 h for BMI > 40 or weight > 150 kg, or Enoxaparin 40 mg every 24 h or 30 mg every 12 h or every 24 h (with Creatine Clearance < 30 mL/min) SQ or Enoxaparin 40 mg every 12 h SC for weight >150kg or BMI > 40‐50 Enoxaparin 60 mg every 12 h SC for BMI > 50 For enoxaparin, antiXA testing will be done after fourth injection only for participants with BMI > 40 or weight > 150 kg as per institutional policy. For participants who develop AKI, and received enoxaparin, transition to IV UFH by checking antiXa when next dose of enoxaparin would be due and initiating IV heparin when antiXa < 0.7 IU/mL
Outcomes	Primary Composite incidence of: all‐cause mortality, cardiac arrest, symptomatic DVT, PE, arterial thromboembolism, myocardial infarction, stroke, or shock (time frame: 30 days) Secondary Score on WHO Ordinal Scale (time frame: 30 days) Incidence of AKI (KDIGO criteria for Acute Kidney Injury (time frame: 30 days) Requirement of invasive mechanical ventilation or ECMO (time frame: 30 days) Cardiac injury (time frame: 30 days) measured by troponin and NT proBNP levels Hypercoagulability (time frame: 30 days) measured by D‐dimer and fibrinogen levels DIC score (time frame: 30 days) Length of Hospital Stay (time frame: 30 days)
Notes	NCT04359277 | No data provided