A multicenter, adaptive, prospective, randomized trial evaluating the efficacy and safety of antithrombotic strategies in patients with COVID-19 following hospital discharge

About this Study

This study is an adaptive, prospective, randomized trial designed to compare the effectiveness and safety of antithrombotic therapy with no antithrombotic therapy after hospitalization for 48 hours or longer for COVID-19. For Stage 1 of this study, participants will be randomized to either prophylactic anticoagulation or no anticoagulant therapy for 30 days, and then followed for an additional 60 days after the completion of treatment (total duration of follow-up, approximately 90 days).

Sponsor Protocol ID:2020V3331
IRB Number:2021V0536
Actively Enrolling
Interventional
Early Phase 1
April 28, 2021
Eligibility Criteria
Both Male and Female
No
No
No

Inclusion Criteria
1. Age ≥ 18 years
2. PCR-positive COVID-19 infection
3.  Hospitalized for 48 or more hours

Exclusion Criteria
1. Existing indication for anticoagulation, either therapeutic or prophylactic dose
2. Contraindication to antithrombotic therapy, such as
a) ischemic stroke, intracranial bleed, or neurosurgery within 3 months
b) Known bleeding within the last 30 days requiring emergency room presentation or
3. hospitalization
c) Known major surgery within 14 days (at least 1 hour and/or requires general
4. anesthesia)
d) Inherited or active acquired bleeding disorder
5. Platelet count
6. Hemoglobin
7. Pregnancy
8. Prison inmate
9. Life expectancy less than 90 days
10. Unwilling or unable to provide informed consent / unwilling or unable to complete the study
11. protocol
12. Other criteria related to arm-specific appendices developed as adaptations to the 

Categories Click category to view its trials.
COVID-19 (Coronavirus)
Participating Locations
University Hospital
Contact Information
Contact Name: Savannah Vann
Phone Number: 601-496-7811
Email: svann@umc.edu
Principal Investigator:Kutcher, Matthew E, M.D.
How to participate in our Clinical Trials