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A Study to Assess Pulsed Inhaled Nitric Oxide vs Placebo in Subjects With Mild or Moderate COVID-19 | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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)

NCT04421508•Bellerophon Pulse Technologies

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed informed consent
•At least 18 years old
•Subjects must be hospitalized and have the following:
•* proven or high suspicion of SARS-CoV-2 infection and,
•* requiring oxygen supplementation defined as:
•* SpO2 ≤ 92% regardless of supplemental oxygen (ie on room air or on oxygen), or
•* SpO2 ≥ 92% on supplemental O2 and in the opinion of the Investigator it is not safe to decrease or remove the supplemental oxygen
•* require supplemental oxygen of no more than 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
+1 more criteria

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
•Chronic use of a nitric oxide donor agent such as nitroglycerin or drugs known to increase methemoglobin such as lidocaine, prilocaine, benzocaine, nitroprusside, isosorbide, or dapsone at screening
•History or clinical evidence of systolic heart failure, left ventricular dysfunction (LVEF \<40%)
•Subjects reporting massive hemoptysis associated with the current illness or with radiologically proven pulmonary embolus

Locations (17)

Banner University Medical Center

Phoenix, Arizona, United States

Kaiser Permanente - Zion Medical Center

San Diego, California, United States

Kaiser Permanente - San Diego Medical Center

San Diego, California, United States

University of Miami Health System

Miami, Florida, United States

The Lung Research Center (St. Luke's)

Chesterfield, Missouri, United States

University of New Mexico Hospital

Albuquerque, New Mexico, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Mercy Health St. Vincent Medical Center

Toledo, Ohio, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Houston Methodist

Houston, Texas, United States

Key Dates

Start Date

July 12, 2020

Primary Completion Date

December 28, 2020

Completion Date

January 22, 2021

Last Updated

February 21, 2023

Enrollment

191

ACTUAL participants

Conditions

COVID-19CoronavirusCoronavirus Infection

Interventions

INOpulse

COMBINATION_PRODUCT

Placebo

COMBINATION_PRODUCT

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NCT06082518

Post COVID-19 ConditionPost-COVID-19 Syndrome+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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