NCT04377997.

Study name	A randomized, open‐label trial of therapeutic anticoagulation in COVID‐19 patients with an elevated D‐dimer
Starting date	15 May 2020
Contact information	Mazen Albaghdadi Massachusetts General Hospital, USA 617‐726‐7400 | MALBAGHDADI@mgh.harvard.edu
Methods	Open‐label, 2‐armed, parallel‐assignment RCT
Participants	300 participants, ≥ 18 years, female and male Inclusion COVID‐19‐positive on admission or during hospitalisation (having been tested within the past 5 days) with symptoms consistent with COVID‐19 including fever (≥ 38 °C (100.4 F)), pneumonia, symptoms of lower respiratory illness (e.g. cough, difficulty breathing), loss of smell or taste, myalgias, pharyngitis, or diarrhoea Admitted to the regular medical floor or ICU without severe SARS (P/F ratio<100) Elevated D‐dimer (> 1.5 g/mL) Age > 18 years and not older than 90 Fibrinogen > 100 Platelets > 50,000 No prior intracranial haemorrhage or recent ischaemic stroke or TIA within 6 months D‐dimer > 1500 ng/mL No other clinical indication for therapeutic anticoagulation (e.g. DVT, PE, atrial fibrillation, acute coronary syndromes, or ECMO) Exclusion DIC according to the ISTH overt DIC definition Haemoglobin < 8 g/dL Hypersensitivity to heparin or heparin formulation including HIT Thrombocytopenia: platelets < 50,000 platelets/µL Uncontrolled or active/recent bleeding including intracranial haemorrhage, signs of active bleeding (e.g. blood transfusion within 30 days), any GI bleed within the past 6 months, or internal bleeding within the past 1 month High bleeding risk: significant closed‐head or facial trauma within 3 months, traumatic or prolonged CPR (> 10 min), or use of dual anti‐platelet therapy Known or suspected pregnancy Recent (< 48 h) or planned spinal or epidural anaesthesia or puncture If the patient is on other anticoagulants, antihistamines, NSAIDs (i.e. aspirin) or hydroxychloroquine Uncontrolled hypertension
Interventions	Experimental: therapeutic anticoagulation group Higher dose (not described) of heparin (LMWH for most participants but UFH for those with morbid obesity or moderate to severe renal dysfunction) Comparator: standard care anticoagulation group There is no dose or drug description.
Outcomes	Primary Risk of the composite efficacy endpoint of death, cardiac arrest, symptomatic DVT, PE, arterial thromboembolism, myocardial infarction, or haemodynamic shock (time frame: 12 weeks) Risk of major bleeding event according to the ISTH definition (time frame: 12 weeks) Secondary There is no description
Notes	NCT04377997 | No data provided