A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation Versus Standard Care as a Rapid Response to (SARS-CoV-2) COVID-19 Pandemic

Summary

Coagulopathy of COVID-19 afflicts approximately 20% of patients with severe COVID-19 and is associated with need for critical care and death. COVID-19 coagulopathy is characterized by elevated D-dimer, an indicator of fibrin formation and clot lysis, and a mildly prolonged prothrombin time, suggestive of coagulation consumption. To date, it seems that COVID-19 coagulopathy manifests with thromboembolism, thus anticoagulation may be of benefit. We propose to conduct a parallel pragmatic multi-centre open-label randomized controlled trial to determine the effect of therapeutic anticoagulation compared to standard care in hospitalized patients admitted for COVID-19 with an elevated D-dimer.

Conditions

• COVID
• Coronavirus Infection
• Severe Acute Respiratory Syndrome
• Thromboembolism, Venous
• Anticoagulants and Bleeding Disorders

Interventions

DRUG

Therapeutic anticoagulation

The choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol.

Sponsors & Collaborators

• Unity Health Toronto

  collaborator OTHER

• University of Vermont Medical Center

  collaborator OTHER

• University of Sao Paulo General Hospital

  lead OTHER

Principal Investigators

• Peter Juni, MD, FESC · St Michael's Hospital, Li Ka Shing Knowledge Institute, University of Toronto

• Elnara M Negri, MD, PhD · Laboratório de Investigação Médica da FMUSP

• Heraldo P de Souza, MD, PhD · Disciplina de Emergências Clínicas, Hospital das Clínicas da FMUSP

• Hassan Rahhal, MD · Disciplina de Emergências Clínicas, Hospital das Clínicas da FMUSP

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-04

Primary Completion

2021-05-10

Completion

2021-10-14

Countries

• Brazil

Study Locations