NCT04421508

A Study to Assess Pulsed Inhaled Nitric Oxide vs Placebo in Subjects With Mild or Moderate COVID-19

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo in Subjects With Mild or Moderate Coronavirus (COVID-19)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 191 (actual)
• Sponsor: Bellerophon Pulse Technologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pulsed inhaled iNO compared to placebo in subjects with COVID-19.

Detailed description

This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pulsed iNO compared to placebo in subjects with COVID-19 who are hospitalized and require supplemental oxygen without assisted ventilation. Subjects will be randomized to receive placebo or iNO125 mcg/kg ideal body weight (IBW)/hour 24 hours daily up to 14 days or until resolution or discharge.

Conditions

• COVID-19
• Coronavirus
• Coronavirus Infection

Interventions

Type	Name	Description
COMBINATION_PRODUCT	INOpulse	Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.
COMBINATION_PRODUCT	Placebo	Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.

Timeline

• Start date: 2020-07-12
• Primary completion: 2020-12-28
• Completion: 2021-01-22
• First posted: 2020-06-09
• Last updated: 2023-02-21
• Results posted: 2023-02-01

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study