Evaluation of the Safety and Efficacy of Razuprotafib in Hospitalized Subjects With Coronavirus Disease 2019

Summary

This was a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter, dose escalation and proof-of-concept study to evaluate the safety and efficacy of razuprotafib, administered 3 times daily (TID) (every 8 hours \[Q8H\]), in hospitalized subjects with moderate to severe Coronavirus disease 2019 (COVID-19) receiving standard of care therapy. The study was planned to include 2 parts with Part 1 comprising the dose escalation period of the study and Part 2 comprising the proof-of-concept safety and efficacy period of the study.

Timeline

Start

2020-10-21

Primary completion

2021-02-26

Completion

2021-02-26

Outcome

Outcome not reported

Stopped (Enrollment): “After completion of Step 1 Part 1, the Sponsor discontinued the study based on challenges associated with recruiting and monitoring patients in the current pandemic environment.”

Drugs

Indications