NCT04746339

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
411

participants targeted

Target at P50-P75 for phase_4 covid19

Timeline
Completed

Started Mar 2021

Typical duration for phase_4 covid19

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
23 days until next milestone

Study Start

First participant enrolled

March 4, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

1.2 years

First QC Date

February 8, 2021

Last Update Submit

August 23, 2022

Conditions

Covid19Thrombosis

Keywords

SARS-CoV2AnticoagulationApixaban

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Hospitalization due to bleeding

    In 30 days

  • Hospitalizations for cardiopulmonary causes

    In 30 days

  • All-cause hospitalization

    In 30 days

  • All-cause death

    In 30 days

  • Days free of venous thromboembolism

    In 30 days

  • +1 more secondary outcomes

Study Arms (2)

Apixaban Group

ACTIVE COMPARATOR
Drug: Apixaban 2.5 MG

Placebo Group

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Apixaban 2.5 MGDRUG

Apixaban 2.5mg twice daily for 30 days

Apixaban Group
PlaceboDRUG

placebo twice daily for 30 days

Placebo Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Age \< 18 years-old
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Maternidade São Vicente de Paulo

Barbalha, Ceará, Brazil

Location

Hospital Universitário São Francisco de Assis

Bragança Paulista, São Paulo, Brazil

Location

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Location

Hospital Santa Paula

São Paulo, Brazil

Location

Related Publications (1)

  • Santos BC, Flumignan RL, Civile VT, Atallah AN, Nakano LC. Prophylactic anticoagulants for non-hospitalised people with COVID-19. Cochrane Database Syst Rev. 2023 Aug 16;8(8):CD015102. doi: 10.1002/14651858.CD015102.pub2.

    PMID: 37591523DERIVED

MeSH Terms

Conditions

COVID-19Thrombosis

Interventions

apixaban

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Renato D. Lopes, MD, PhD

    BCRI

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 9, 2021

Study Start

March 4, 2021

Primary Completion

May 13, 2022

Study Completion

May 30, 2022

Last Updated

August 25, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

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

Locations

BR(4)