Coagulopathy of COVID-19: A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation Versus Standard Care

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-19

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

• University of Vermont Medical Center

  collaborator OTHER

• University of Sao Paulo

  collaborator OTHER

• Hopital Charles Lemoyne

  collaborator OTHER

• William Osler Health System

  collaborator OTHER

• MOUNT SINAI HOSPITAL

  collaborator OTHER

• Trillium Health Partners

  collaborator OTHER

• St. Joseph's Health Centre Toronto

  collaborator OTHER

• The Ottawa Hospital

  collaborator OTHER

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

  collaborator OTHER

• Michael Garron Hospital

  collaborator OTHER

• University of Alberta

  collaborator OTHER

• Southlake Regional Health Centre

  collaborator OTHER

• Maisonneuve-Rosemont Hospital

  collaborator OTHER

• Queen Elizabeth II Health Sciences Centre

  collaborator OTHER

• Foothills Medical Centre

  collaborator OTHER

• Alberta Health services

  collaborator OTHER

• Peter Lougheed Centre

  collaborator OTHER

• Mater Misericordiae University Hospital

  collaborator OTHER

• King Saud Medical City

  collaborator OTHER_GOV

• King Fahad Medical City

  collaborator OTHER_GOV

• King Faisal Specialist Hospital & Research Center

  collaborator OTHER

• Versiti

  collaborator OTHER

• Barnes-Jewish Hospital

  collaborator OTHER

• Al Ain Hospital

  collaborator OTHER

• Unity Health Toronto

  lead OTHER

Principal Investigators

• Michelle Sholzberg, MD, FRCPC · Unity Health Toronto

• Peter Jüni, MD, FESC · Unity Health Toronto

• Mary Cushman, MD · University of Vermont Medical Center, Vermont

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-05-11

Primary Completion

2021-05-10

Completion

2021-10-14

Countries

• Canada

Study Locations