NCT04360824.

Study name	COVID‐19‐associated coagulopathy: safety and efficacy of prophylactic anticoagulation therapy in hospitalized adults with COVID‐19
Starting date	6 May 2020
Contact information	Usha Perepu University of Iowa, Iowa City, Iowa, USA 319‐356‐2195 | usha‐perepu@uiowa.edu
Methods	Multicentre, open‐label, 2‐armed, parallel‐assignment RCT
Participants	170 participants, ≥ 18 years, female and male Inclusion criteria Laboratory‐confirmed SARS‐CoV‐2 infection Age: ≥ 18 years Requires hospital admission for further clinical management Modified ISTH overt DIC score ≥ 3 Exclusion criteria Indication for full therapeutic‐dose anticoagulation Acute VTE (DVT or PE) within prior 3 months Acute cardiovascular event within prior 3 months Acute stroke (ischaemic or haemorrhagic) within prior 3 months Active major bleeding Severe thrombocytopenia (< 25,000/mm3) Increased risk of bleeding, as assessed by the investigator Acute or chronic renal insufficiency with creatinine clearance < 30 mL/min calculated by the modified Cockcroft and Gault formula Weight < 40 kg Known allergies to ingredients contained in enoxaparin, allergy to heparin products or history of HIT
Interventions	Interventional: intermediate‐dose enoxaparin (1 mg/kg SC daily if BMI < 30 kg/m2 or 0.5 mg/kg SC twice daily if BMI ≥ 30 kg/m2) Comparator: standard of care. Standard prophylactic dose enoxaparin (40 mg SC daily if BMI < 30 kg/m2 and 30 mg SC twice daily or 40 mg SC twice daily if BMI ≥ 30 kg/m2)
Outcomes	Primary Risk of all‐cause mortality (time frame: 30 days post‐intervention) Secondary Risk of ISTH‐defined major bleeding (time frame: 30 days post‐intervention) Arterial thrombosis (time frame: 30 days post‐intervention). Risk of ischaemic stroke, myocardial infarction and/or limb ischaemia VTE (time frame: 30 days post‐intervention). Risk of symptomatic VTE ICU admission, intubation/ventilation (time frame: 30 days post‐intervention). Duration of intensive care measures PRBC transfusions (time frame: 30 days post‐intervention). The number of units of PRBCs transfused Platelet transfusions (time frame: 30 days post‐intervention). The number of units of platelets transfused Fresh frozen plasma transfusions (time frame: 30 days post‐intervention). The number of units of fresh frozen plasma transfused Cryoprecipitate transfusions (time frame: 30 days post‐intervention). The number of units of cryoprecipitate transfused Prothrombin complex concentrate transfusions (time frame: 30 days post‐intervention). The number of units of prothrombin complex concentrate transfused Other outcomes The endogenous thrombin potential will be determined within 24 h of randomisation and weekly for 30 days or until hospital discharge (time frame: 30 days post‐intervention). Will be performed in stored plasma using calibrated automated thrombogram. The endogenous thrombin potential will be calculated in units of nM.Min Plasma levels of cell‐free DNA will be determined within 24 h of randomisation and weekly for 30 days or until hospital discharge (time frame: 30 days post‐intervention). These assays will be performed in stored plasma. Quantification of cfDNA will be performed using Qubit dsDNA HS Assay kit. Histones H4, citrullinated‐histone and DNA‐myeloperoxidase will be measured using commercially available ELISA kit. PAI‐1 (time frame: 30 days post‐intervention) will be measured in stored plasma using a commercially available ELISA kit.
Notes	NCT04360824 | No data provided