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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
411
Apixaban 2.5mg twice daily for 30 days
placebo twice daily for 30 days
Hospital Maternidade São Vicente de Paulo
Barbalha, Ceará, Brazil
Hospital Universitário São Francisco de Assis
Bragança Paulista, São Paulo, Brazil
Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil
Hospital Santa Paula
São Paulo, Brazil
Number of days alive and out of hospital or emergency department
Number of days alive and out of hospital or emergency department through 30 days.
Time frame: In 30 days
Hospitalization due to bleeding
Time frame: In 30 days
Hospitalizations for cardiopulmonary causes
Time frame: In 30 days
All-cause hospitalization
Time frame: In 30 days
All-cause death
Time frame: In 30 days
Days free of venous thromboembolism
Venous thromboembolism (VTE) include deep venous thrombosis and pulmonary embolism.
Time frame: In 30 days
Major cardiovascular events (MACE)
Major cardiovascular events (MACE) includes cardiovascular death, myocardial infarction (MI) and stroke.
Time frame: In 30 days
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