Apixaban for PrOphyLaxis of thromboemboLic Outcomes in COVID-19
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- COVID-19
- Thrombosis
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Randomized, double-blinded, placebo-controlled trial comparing oral anticoagulation with placebo for community-dwelling patients with symptomatic COVID-19 infection and risk factors for thrombosis. Randomization 1:1 - Group 1 will receive Apixaban 2.5mg twice daily vs. matching placebo (Group 2) for...
Randomized, double-blinded, placebo-controlled trial comparing oral anticoagulation with placebo for community-dwelling patients with symptomatic COVID-19 infection and risk factors for thrombosis. Randomization 1:1 - Group 1 will receive Apixaban 2.5mg twice daily vs. matching placebo (Group 2) for 30 days. Primary Objective: To evaluate the clinical impact of a strategy of oral anticoagulation with apixaban comparing with placebo on the number of days alive and out of the hospital/emergency department (DAOH) through 30 days in outpatients with symptomatic SARS-CoV2 infection and risk factors for thrombosis.
Tracking Information
- NCT #
- NCT04746339
- Collaborators
- Hospital Israelita Albert Einstein
- Hospital do Coracao
- Hospital Sirio-Libanes
- Hospital Moinhos de Vento
- Hospital Alemão Oswaldo Cruz
- Beneficência Portuguesa de São Paulo
- Brazilian Research In Intensive Care Network
- Investigators
- Study Chair: Renato D. Lopes, MD, PhD BCRI