Official Title
Apixaban for PrOphyLaxis of thromboemboLic Outcomes in COVID-19 - the Apollo Trial
Brief 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.

Detailed 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 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.

Terminated
COVID19
Thrombosis

Drug: Apixaban 2.5 MG

Apixaban 2.5mg twice daily for 30 days

Drug: Placebo

placebo twice daily for 30 days

Eligibility 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)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Brazil
Locations

Hospital Maternidade São Vicente de Paulo
Barbalha, Ceará, Brazil

Hospital Israelita Albert Einstein
São Paulo, SP, Brazil

Hospital Universitário São Francisco de Assis
Bragança Paulista, São Paulo, Brazil

Hospital Santa Paula
São Paulo, Brazil

Renato D. Lopes, MD, PhD, Study Chair
BCRI

Brazilian Clinical Research Institute
NCT Number
Keywords
SARS-CoV2
anticoagulation
Apixaban
MeSH Terms
COVID-19
Thrombosis
Apixaban