Apixaban for PrOphyLaxis of thromboemboLic Outcomes in COVID-19

Covid19 Clinical Trial

— APOLLO  

Official title:

Apixaban for PrOphyLaxis of thromboemboLic Outcomes in COVID-19 - the Apollo Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04746339
• Other study ID #: 004/2020
• Status: Terminated
• Phase: Phase 4
• Start date: March 4, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: August 2022
• Source: Brazilian Clinical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 411
• Est. completion date: May 30, 2022
• Est. primary completion date: May 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Thrombosis

Intervention

Drug:
• Apixaban 2.5 MG
Apixaban 2.5mg twice daily for 30 days
• Placebo
placebo twice daily for 30 days

Locations

Country	Name	City	State
Brazil	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	SP
Brazil	Hospital Santa Paula	São Paulo

Sponsors (8)

Lead Sponsor	Collaborator
Brazilian Clinical Research Institute	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

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	In 30 days
Secondary	Hospitalization due to bleeding		In 30 days
Secondary	Hospitalizations for cardiopulmonary causes		In 30 days
Secondary	All-cause hospitalization		In 30 days
Secondary	All-cause death		In 30 days
Secondary	Days free of venous thromboembolism	Venous thromboembolism (VTE) include deep venous thrombosis and pulmonary embolism.	In 30 days
Secondary	Major cardiovascular events (MACE)	Major cardiovascular events (MACE) includes cardiovascular death, myocardial infarction (MI) and stroke.	In 30 days