Apixaban for PrOphyLaxis of thromboemboLic Outcomes in COVID-19

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Brazilian Clinical Research Institute
• Collaborators: Beneficência Portuguesa de São Paulo; Brazilian Research In Intensive Care Network; Hospital Alemão Oswaldo Cruz; Hospital do Coracao; Hospital Israelita Albert Einstein; Hospital Moinhos de Vento; Hospital Sirio-Libanes
• Treatments: Apixaban

Criteria

Inclusion Criteria:

• Outpatients with symptomatic laboratory-proven diagnosis of COVID-19 (any exam that shows acute infection as positive PCR or IgM in a context of acute symptoms ≤ 10 days) AND

• Negative pregnancy test for women in child bearing period AND

• D-dimer level ≥ 2x ULN or

• C-reactive protein (CRP) ≥ 10 mg/L or

• At least two of the following risk factors:

• d-dimer level ≥ULN

• CRP ≥ULN

• age ≥65,

• diabetes,

• chronic kidney disease stage 3

• cardiopulmonary disease (for example, peripheral arterial disease, coronary artery disease, heart failure, chronic obstructive pulmonary disease),

• history of PE/DVT,

• nursing home/SNF resident or severely restricted mobility

• Body mass index ≥30 kg/m2.

Exclusion Criteria:

• Age < 18 years-old

• Patients with indication for full anticoagulation during inclusion (for example, diagnosis of venous thromboembolism, atrial fibrillation, mechanical valve prosthesis)

• Platelets < 50,000 /mm3

• Use of acetylsalicylic acid > 100 mg per day

• Use of P2Y12 inhibitor (clopidogrel, prasugrel, ticagrelor)

• Chronic use of NSAIDs

• Hypersensitivity to apixaban

• Creatinine clearance < 30 ml/min

• Pregnancy or breastfeeding

• Patients contraindicated to anticoagulation (active bleeding, recent major surgery, blood dyscrasia or prohibitive hemorrhage risk as evaluated by the investigator)

• A history of hemorrhagic stroke or any intracranial bleeding at any time in the past or current intracranial neoplasm (benign or malignant), cerebral metastases, arteriovenous (AV) malformation, or aneurysm

• Use of strong inhibitors of cytochrome P450 (CYP) 3A4 and/or P-glycoprotein (P-gp) (e.g. protease inhibitors, ketoconazole, Itraconazole) and/or use of P-gp and strong CYP3A4 inducers (such as but not limited to rifampin/rifampicin, rifabutin, rifapentine, phenytoin, phenobarbital, carbamazepine, or St. John's Wort)