Covid-19 Associated Coagulopathy

• Status: Recruiting
• Trial end date: 2021-04-16
• Target enrollment: 0
• Participant gender: All

Summary

This prospective, randomized, open-label, multi-center interventional study is designed to compare the safety and efficacy of two LMWH dosing protocols in patients admitted to the University of Iowa Hospitals with COVID-19 who meet the modified ISTH Overt DIC criteria score ≥3. Patients will be randomized to standard prophylactic dose LMWH (standard of care arm) or intermediate-dose LMWH (intervention arm).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Iowa
• Treatments: Enoxaparin

Criteria

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 venous thromboembolism (deep vein thrombosis or pulmonary embolism) within prior 3 months

• Acute cardiovascular event within prior 3 months

• Acute stroke (ischemic or hemorrhagic) 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 heparin induced thrombocytopenia