Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia

Phase 3 Withdrawn D'Or Institute for Research and Education

RandomizedFactorialOpen-labelTreatment

Summary

The COVID-19 pandemic has been spreading continuously, and in Brazil, until July 19, 2020, there have been more than 2,000,000 cases with more than 79,000 deaths, with daily increases. The present study proposes to evaluate the efficacy of methylprednisolone and heparin in treatment of patients with COVID-19 pneumonia in a randomized, controlled, 2x2 factorial study.

Timeline

Start: 2020-07-20
Primary completion: 2022-12-31
Completion: 2022-12-31

Outcome

Outcome not reported

Stopped: “It was not possible to perform the study due to the availability and logistics of porcine heparin”

Publications

Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enoxaparin sodium	Other / unclassified	1 mg/kg	Subcutaneous
Subject	HEPARIN CALCIUM	Other / unclassified	—	—
Subject	Methylprednisolone	Other / unclassified	0.5 mg/kg	Intravenous