Official Title
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)
Brief 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.

Terminated
COVID-19
Coronavirus
Coronavirus Infection

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.

Eligibility Criteria

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

- 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

- 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

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

INOVA
Falls Church, Virginia, United States

St. Francis Medical Center
Richmond, Virginia, United States

Memorial Regional Medical Center
Richmond, Virginia, United States

Chippenham Medical Center
Richmond, Virginia, United States

Pulmonary Associates of Richmond
Richmond, Virginia, United States

St. Mary's Hospital
Richmond, Virginia, United States

Johnston-Willis Hospital
Richmond, Virginia, United States

Ashika Ahmed, MD, Study Director
Bellerophon Therapeutics

Bellerophon Pulse Technologies
NCT Number
Keywords
Covid
SARS-CoV-2
iNO
INOpulse
Severe Acute Respiratory Syndrome (SARS) Pneumonia
Severe acute respiratory syndrome coronavirus 2
SARS-CoV 2
COViNOX
pulsed inhaled nitric oxide
inhaled nitric oxide
portable pulsed inhaled nitric oxide
Nitric Oxide
MeSH Terms
COVID-19
Coronavirus Infections