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Apixaban for PrOphyLaxis of thromboemboLic Outcomes in COVID-19 (APOLLO)

Primary Purpose

Covid19, Thrombosis

Status

Terminated

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Apixaban 2.5 MG

Placebo

About this trial

This is an interventional prevention trial for Covid19 focused on measuring SARS-CoV2, Anticoagulation, Apixaban

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Hospital Maternidade São Vicente de Paulo
Hospital Israelita Albert Einstein
Hospital Universitário São Francisco de Assis
Hospital Santa Paula

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Apixaban Group

Placebo Group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Hospitalization due to bleeding

Hospitalizations for cardiopulmonary causes

All-cause hospitalization

All-cause death

Days free of venous thromboembolism

Venous thromboembolism (VTE) include deep venous thrombosis and pulmonary embolism.

Major cardiovascular events (MACE)

Major cardiovascular events (MACE) includes cardiovascular death, myocardial infarction (MI) and stroke.

Full Information

NCT ID

NCT04746339

First Posted

February 8, 2021

Last Updated

August 23, 2022

Sponsor

Brazilian Clinical Research Institute

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

1. Study Identification

Unique Protocol Identification Number

NCT04746339

Brief Title

Apixaban for PrOphyLaxis of thromboemboLic Outcomes in COVID-19

Acronym

APOLLO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Terminated

Why Stopped

Due to the decrease in COVID cases and in the recruitment rate, and DSMB orientation.

Study Start Date

March 4, 2021 (Actual)

Primary Completion Date

May 13, 2022 (Actual)

Study Completion Date

May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Brazilian Clinical Research Institute

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19, Thrombosis

Keywords

SARS-CoV2, Anticoagulation, Apixaban

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

411 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apixaban Group

Arm Type

Active Comparator

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Apixaban 2.5 MG

Intervention Description

Apixaban 2.5mg twice daily for 30 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

placebo twice daily for 30 days

Primary Outcome Measure Information:

Title

Number of days alive and out of hospital or emergency department

Description

Number of days alive and out of hospital or emergency department through 30 days.

Time Frame

In 30 days

Secondary Outcome Measure Information:

Title

Hospitalization due to bleeding

Time Frame

In 30 days

Title

Hospitalizations for cardiopulmonary causes

Time Frame

In 30 days

Title

All-cause hospitalization

Time Frame

In 30 days

Title

All-cause death

Time Frame

In 30 days

Title

Days free of venous thromboembolism

Description

Venous thromboembolism (VTE) include deep venous thrombosis and pulmonary embolism.

Time Frame

In 30 days

Title

Major cardiovascular events (MACE)

Description

Major cardiovascular events (MACE) includes cardiovascular death, myocardial infarction (MI) and stroke.

Time Frame

In 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Renato D. Lopes, MD, PhD

Organizational Affiliation

BCRI

Official's Role

Study Chair

Facility Information:

Facility Name

Hospital Maternidade São Vicente de Paulo

City

Barbalha

State/Province

Ceará

Country

Brazil

Facility Name

Hospital Israelita Albert Einstein

City

São Paulo

State/Province

Country

Brazil

Facility Name

Hospital Universitário São Francisco de Assis

City

Bragança Paulista

State/Province

São Paulo

Country

Brazil

Facility Name

Hospital Santa Paula

City

São Paulo

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All data provided during study is anonymized to respect the privacy of patients who have participated in the trial in line with applicable regulations.

Learn more about this trial

Apixaban for PrOphyLaxis of thromboemboLic Outcomes in COVID-19

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