drugset / Trial / NCT04356677

Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19_#2

NCT04356677 ↗

Phase 1 Withdrawn Bausch Health Americas, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is a Phase 1, open label, non-randomized, two-arm interventional clinical trial to evaluate the safety and efficacy of Virazole® in hospitalized adult patients who have tested positive for COVID-19 and, as a result, have significant respiratory distress (PaO2/FiO2 ratio \<300 mmHg).

Timeline

Start
2021-05
Primary completion
2021-08
Completion
2021-08

Outcome

Outcome not reported

Stopped (Enrollment): “Due to pandemic status changing in Canada prior to investigative sites being initiated for participation, and that concurrent participant recruitment in the global study BHC-RIB-5401-GL will achieve target enrollment across all countries.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Ribavirin Small molecule 50 mg/ml Inhaled
Subject Ribavirin Small molecule 100 mg/ml Inhaled

Indications