drugset / Trial / NCT04600141
Clinical Efficacy of Heparin and Tocilizumab in Patients With Severe COVID-19 Infection
Phase 3
Completed
308 enrolled
University of Sao Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The COVID-19 infection primarily manifests itself as a respiratory tract infection, although new evidence indicates that this disease has systemic involvement involving multiple systems including the cardiovascular, respiratory, gastrointestinal, neurological, hematopoietic and immune systems. Recent studies have shown that in its pathophysiology, inflammation and thrombogenesis predominate, especially in the severe forms of COVID-19. Thus, the investigators hypothesized that the use of heparin and tocilizumab could potencially reduce inflammation and thrombogenesis in patients with severe COVID-19 infection, improving patients outcomes and survival.
Timeline
- Start
- 2020-11-10
- Primary completion
- 2021-10-20
- Completion
- 2021-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enoxaparin sodium | Other / unclassified | 1 mg/kg | Subcutaneous |
| Subject | Enoxaparin sodium | Other / unclassified | 40 mg | Subcutaneous |
| Subject | Heparin | Other / unclassified | 18 iu/kg | Intravenous |
| Subject | Heparin | Other / unclassified | 5000 iu | Subcutaneous |
| Subject | Tocilizumab | Monoclonal antibody | 8 mg/kg | Intravenous |