Covid-19 Associated Coagulopathy

Completed · Phase 4

Conditions studied: COVID 19 Associated Coagulopathy

In brief

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).

Key facts

Study ID

NCT04360824

Run by

University of Iowa

People needed

176

Starts

2020-05-06

Expected to finish

2021-04-16

Last updated by the study team

2023-03-01

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Laboratory confirmed SARS-CoV-2 infection
• Age ≥18 years
• Requires hospital admission for further clinical management
• Modified ISTH Overt DIC score ≥ 3

You may not qualify if…

• 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

Where it is running

• University of Iowa — Iowa City, Iowa, United States
• Gundersen Health System — La Crosse, Wisconsin, United States

Full record on ClinicalTrials.gov

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