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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-12

Study Completion Date

2021-01-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COVID-19 Coronavirus Coronavirus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Inhaled Nitric Oxide (iNO)

Pulsed inhaled iNO 125 mcg/kg IBW/hour

Group Type ACTIVE_COMPARATOR

INOpulse

Intervention Type COMBINATION_PRODUCT

Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.

Placebo

Pulsed inhaled N2, 99.999% gas

Group Type SHAM_COMPARATOR

Placebo

Intervention Type COMBINATION_PRODUCT

Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.

Interventions

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INOpulse

Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.

Intervention Type COMBINATION_PRODUCT

Placebo

Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ashika Ahmed, MD

Role: STUDY_DIRECTOR

Bellerophon Therapeutics

Locations

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Banner University Medical Center

Phoenix, Arizona, United States

Site Status

Kaiser Permanente - Zion Medical Center

San Diego, California, United States

Site Status

Kaiser Permanente - San Diego Medical Center

San Diego, California, United States

Site Status

University of Miami Health System

Miami, Florida, United States

Site Status

The Lung Research Center (St. Luke's)

Chesterfield, Missouri, United States

Site Status

University of New Mexico Hospital

Albuquerque, New Mexico, United States

Site Status

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status

Mercy Health St. Vincent Medical Center

Toledo, Ohio, United States

Site Status

Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Houston Methodist

Houston, Texas, United States

Site Status