Overview

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