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
Phase 3
Completed
465 enrolled
University of Sao Paulo General Hospital
Unity Health Toronto · collabUniversity of Vermont Medical Center · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dalteparin sodium | Other / unclassified | — | — |
| Subject | Enoxaparin sodium | Other / unclassified | — | — |
| Subject | Heparin | Other / unclassified | — | — |
| Subject | Tinzaparin | Other / unclassified | — | — |