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

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.

Timeline

Start

2020-07-12

Primary completion

2020-12-28

Completion

2021-01-22

Outcome

Missed primary endpoint

Stopped: “Futility”

registry analysis (superiority test); Inhaled Nitric Oxide (iNO) vs Placebo; p = 0.6316; Odds Ratio (OR) 0.36 NCT04421508 ↗

registry analysis (superiority test); Inhaled Nitric Oxide (iNO) vs Placebo; p = 0.4127; Odds Ratio (OR) 1.502 (95% CI 0.567 to 3.977) NCT04421508 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nitric Oxide	Other / unclassified	125 ug/kg	Inhaled

Indications