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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)

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Trial Profile

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: Discontinued
Phase of Trial: Phase III

Latest Information Update: 23 Feb 2023

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At a glance

  • Drugs Nitric oxide (Primary)
  • Indications COVID-19 respiratory infection; Respiratory insufficiency
  • Focus Registrational; Therapeutic Use
  • Acronyms COViNOX
  • Sponsors Bellerophon Therapeutics

Most Recent Events

  • 11 Mar 2021 According to a Bellerophon Therapeutics media release, after completion of the protocol defined monitoring period, the safety and efficacy analysis of the full 191 patients was reviewed by the DMC, and the DMC determined that there were no safety concerns attributed to INOpulse. However, based on the absence of an efficacy signal and the availability of multiple vaccines, the Company will not be continuing the COViNOX trial.
  • 11 Mar 2021 Status changed from suspended to discontinued, according to a Bellerophon Therapeutics media release.
  • 23 Nov 2020 According to a Bellerophon Therapeutics media release, 200 patients have been recruited till date and the company intend to complete the study procedures for the remaining patients and evaluate the full data set, which will include additional clinically important endpoints, such as change in clinical status and duration of hospitalization, in order to assess potential next steps in our COVID-19 program.

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