NCT04401527

Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite

Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Study

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hope Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Nitrite Injection for treatment of patients infected with COVID-19 who develop lung injury and require mechanical ventilation.

Detailed description

This Phase 2, multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Nitrite Injection for treatment of patients infected with COVID-19 who develop lung injury and require mechanical ventilation. The primary objective is to compare the two treatment groups with respect to the proportion of study subjects who are alive and free of respiratory failure at Day 28.

Conditions

• COVID-19
• Acute Respiratory Distress Syndrome
• Acute Respiratory Failure

Interventions

Type	Name	Description
DRUG	Sodium Nitrite	Continuous intravenous infusion of Sodium Nitrite Injection
DRUG	Normal Saline	Continuous intravenous infusion of Normal Saline

Timeline

• Start date: 2020-07-22
• Primary completion: 2020-08-15
• Completion: 2020-08-15
• First posted: 2020-05-26
• Last updated: 2020-09-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study