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Full Anticoagulation Versus Prophylaxis in COVID-19: COALIZAO ACTION Trial

NCT04394377 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 615

Last updated 2021-06-10

No results posted yet for this study

Summary

Pragmatic randomized clinical trial of patients admitted to the hospital with confirmed COVID-19 infection and elevated D-Dimer.

Randomization 1:1 - Group 1 will undergo a routine full anticoagulation (oral or parenteral when needed) strategy; and group 2 will receive usual standard of care with prophylactic anticoagulation

Conditions

  • Coronavirus Infection

Interventions

DRUG

Group 1: Rivaroxaban 20mg/d followed by enoxaparin/unfractionated heparin when needed

Routine full anticoagulation strategy

DRUG

Group 2: control group with enoxaparin 40mg/d

Usual standard of care and currently have no indication of full anticoagulation.

Sponsors & Collaborators

  • Hospital Israelita Albert Einstein

    collaborator OTHER

  • Hospital do Coracao

    collaborator OTHER

  • Hospital Sirio-Libanes

    collaborator OTHER

  • Hospital Moinhos de Vento

    collaborator OTHER

  • Hospital Alemão Oswaldo Cruz

    collaborator OTHER

  • Beneficência Portuguesa de São Paulo

    collaborator OTHER

  • Brazilian Research In Intensive Care Network

    collaborator NETWORK

  • Brazilian Clinical Research Institute

    lead OTHER

Principal Investigators

  • Renato D. Lopes, MD, PhD · BCRI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-21
Primary Completion
2021-03-26
Completion
2021-05-30

Countries

  • Brazil

Study Locations

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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 NCT04394377 on ClinicalTrials.gov