Prevention of Arteriovenous Thrombotic Events in Critically-Ill COVID-19 Patients Trial

• Status: Recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, open-label, 2x2 factorial, randomized-controlled trial in critically-ill patients with novel coronavirus disease 2019 (COVID-19) evaluating the efficacy and safety of full-dose vs. standard prophylactic dose anticoagulation and of antiplatelet vs. no antiplatelet therapy for prevention of venous and arterial thrombotic events.

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

Details

• Lead Sponsor: The TIMI Study Group
• Treatments: Calcium heparin; Clopidogrel; Enoxaparin; Enoxaparin sodium; Heparin

Criteria

Inclusion Criteria:

1. Age ≥18 years (male or female)

2. Acute infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV2)

3. Currently admitted to an intensive care unit (ICU)

Key Exclusion Criteria:

1. Ongoing (>48 hours) or planned full-dose (therapeutic) anticoagulation for any indication

2. Ongoing or planned treatment with dual antiplatelet therapy

3. Contraindication to antithrombotic therapy or high risk of bleeding due to conditions including, but not limited to, any of the following:

1. History of intracranial hemorrhage, known CNS tumor or CNS vascular abnormality

2. Active or recent major bleeding within the past 30 days with untreated source

3. Platelet count <70,000 or known functional platelet disorder

4. Fibrinogen <200 mg/dL

5. International normalized ratio (INR) >1.9

4. History of heparin-induced thrombocytopenia

5. Ischemic stroke within the past 2 weeks

Patients who meet the following criterion are excluded from the second randomization (antiplatelet therapy vs. no antiplatelet therapy):

1. Ongoing or planned antiplatelet therapy, including aspirin monotherapy