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COVID-19 Antithrombotic Rivaroxaban Evaluation

NCT04757857 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2023-01-25

No results posted yet for this study

Summary

There are several ways in which the COVID-19 pandemic may affect the prevention and management of thrombotic and thromboembolic disease, either direct effect or the indirect effects of infection, such as through severe illness and hypoxia, may predispose patients to thrombotic events. The severe inflammatory response, critical illness, and underlying traditional risk factors may all predispose to thrombotic events. Therefore, considering the high-risk profile of cardiovascular comorbidities in patients with COVID-19, it is scientifically relevant to evaluate the use of anticoagulants as an adjunctive treatment in the context of COVID-19. Indeed, it will be tested the hypothesis that the use of moderate dose of rivaroxaban has a beneficial effect in the treatment of patients with a confirmed or probable diagnosis of COVID-19 infection, with no clear indication for hospitalization (mild and moderate cases) upon initial medical care, by reducing the need of hospitalization due to complications related to COVID-19.

Conditions

Interventions

DRUG

Rivaroxaban 10 mg

Rivaroxaban pharmaceutical form will be tablets of 10 mg

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Hospital Israelita Albert Einstein

    collaborator OTHER

  • Hospital do Coracao

    collaborator OTHER

  • Hospital Sirio-Libanes

    collaborator OTHER

  • Hospital Moinhos de Vento

    collaborator OTHER

  • Brazilian Research In Intensive Care Network

    collaborator NETWORK

  • Brazilian Clinical Research Institute

    collaborator OTHER

  • Hospital Alemão Oswaldo Cruz

    lead OTHER

Principal Investigators

  • Álvaro Avezum, Ph.D · International Research Center - Hospital Alemão Oswaldo Cruz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-29
Primary Completion
2022-08-08
Completion
2022-08-30

Countries

  • Brazil

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04757857 on ClinicalTrials.gov