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

STATUS

Recruiting
participants needed

500
sponsor

Bellerophon Pulse Technologies

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Updated on 19 February 2024

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ct scan

treatment regimen

x-rays

pneumonia

nitric oxide

covid-19

chest x-ray

SARS

oxygen supplementation

acute respiratory syndrome (sars)

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.

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.

Details

Condition	Coronavirus Infection, Coronavirus, Covid 19
Age	18-100 years
Treatment	Placebo, INOpulse
Clinical Study Identifier	NCT04421508
Sponsor	Bellerophon Pulse Technologies
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Signed informed consent
	At least 18 years old
	Symptoms of shortness of breath within previous 8 days prior to screening
	Subjects must have
	proven or high suspicion of SARS-CoV-2 infection and
	O2 saturation < 92% on room air, and
	require supplemental O2 10 L/minute, and
	radiologic suspected or proven COVID-19 pneumonitis (chest x-ray or CT scan)
	Female subjects must have a negative pregnancy test
	Willing and able to comply with the treatment schedule and study procedures
Exclusion Criteria
	Participating in another clinical trial of an investigational treatment for COVID-19
	Methemoglobin > 3%
	Evidence of severe multi organ failure
	Use of assisted ventilation prior to initiation of iNO
	Pregnancy or positive pregnancy test pre-dose
	Open tracheostomy
	Use of a nitric oxide donor agent such as nitroglycerin or drugs known to increase methemoglobin such as lidocaine, prilocaine, benzocaine or dapsone at screening
	History or clinical evidence of heart failure, left ventricular dysfunction (LVEF <40%)
	Subjects reporting hemoptysis

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Study Definition

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