drugset / Trial / NCT04444700

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

NCT04444700

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-07-04
Primary completion
2021-05-10
Completion
2021-10-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Dalteparin sodium Other / unclassified
Subject Enoxaparin sodium Other / unclassified
Subject Heparin Other / unclassified
Subject Tinzaparin Other / unclassified