NCT04406389.

Study name	InterMediate ProphylACtic versus Therapeutic dose anticoagulation in critically ill patients with COVID‐19: a prospective randomized study (The IMPACT Trial)
Starting date	13 October 2020
Contact information	Maria T DeSancho, MD, MSc Weill Cornell Medicine New York, New York, United States, 10065 646‐962‐2065 | mtd2002@med.cornell.edu
Methods	Open‐label, 2‐armed, 1:1, parallel‐assignment RCT
Participants	186 participants, ≥ 18 years, female and male Inclusion criteria: Age >18 years old COVID‐19 positive on (RT‐PCR) nasopharyngeal swab, or suspected COVID‐19 infection with detectable SARS‐CoV‐2 IgG or IgM ICU patient or non‐ICU patient on invasive mechanical ventilation, BiPAP, 100% non‐rebreather mask, or high‐flow oxygen or supplemental oxygen of at least 4 L/min nasal cannula D‐dimer level > 700 ng/mL (3 times the ULN) Exclusion criteria: Objectively documented DVT or PE Patients in whom there is very high suspicion for PE and are on full‐dose anticoagulation as per the treating physician Platelets < 30,000 not due to DIC, based on ISTH criteria and American Society of Hematology (ASH) Frequently Asked Questions Active bleeding that poses a contraindication to therapeutic anticoagulation in the opinion of the investigator History of bleeding diathesis (e.g. haemophilia, severe von Willebrand disease, severe thrombocytopathy) History of intracranial haemorrhage in the last 90 days History of ischaemic stroke in the past 2 weeks Major neurosurgical procedure in the past 30 days Cardiothoracic surgery in the past 30 days Intra‐abdominal surgery in the past 30 days Intracranial malignancy Patients who require therapeutic anticoagulation for other reasons like atrial fibrillation, DVT, PE, or antiphospholipid syndrome
Interventions	Experimental: therapeutic‐dose anticoagulation Participants will receive 1 of the following interventions, at their physician's discretion UFH to target anti‐Xa level 0.3‐0.7 IU/mL or aPTT (according to institutional protocol) Enoxaparin 1 mg/kg SC every 12 h Argatroban (if HIT), dosed according to institutional protocol Fondaparinux (if HIT and CrCl ≥ to 50 mL/min) dosed by weight: ≥ 100 kg: 10 mg daily < 100 kg but ≥50 kg: 7.5 mg daily < 50 kg: 5 mg daily Comparator: intermediate‐dose prophylaxis Participants will receive 1 of the following interventions, at their physician's discretion Enoxaparin 0.5 mg/kg SC every 12 h if CrCl ≥ 30 mL/min Enoxaparin 0.5 mg/kg SC every 24 h if CrCl < 30 mL/min If patient develops acute kidney injury: UFH 7500 units SC every 8 h Fondaparinux (if history of HIT) 2.5 mg daily SC
Outcomes	Primary 30‐day mortality (time frame: 30 days) Secondary Length of ICU stay in days (time frame: 6 months) Number of documented VTE, arterial thrombosis (stroke, myocardial infarction, other) and microthrombosis events (time frame: 6 months) Number of major and clinically relevant non‐major bleeding events (time frame: 6 months)
Notes	NCT04406389 | No data provided