NCT04600141

Clinical Efficacy of Heparin and Tocilizumab in Patients With Severe COVID-19 Infection

Clinical Efficacy of Heparin and Tocilizumab in Patients With Severe COVID-19 Infection: a Randomized Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 308 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Tocilizumab	Tocilizumab infusion 8mg/kg/dose - Intravenous single dose.
DRUG	Heparin - Therapeutic dosage	Intravenous Non-Fractional Heparine (HNF) starting at 18UI/kg/h adjusted according to a nomogram to achieve an Activated Partial Thromboplastin Time (ATTP) from 1.5 To 2.0 times the reference Value; or Low Molecular Weight Heparin (LMWH) subcutaneous dosage of 1mg/kg per dose every 12 hours
DRUG	Heparin - Prophylactic dosage	Subcutaneous Non-Fractional Heparine 5000U every 8 hours OR Subcutaneous Low Molecular Weight (LMWH) 40mg/day.

Timeline

• Start date: 2020-11-10
• Primary completion: 2021-10-20
• Completion: 2021-12-31
• First posted: 2020-10-23
• Last updated: 2022-03-18

Locations

3 sites across 1 country: Brazil