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

Phase 3

Terminated

Conditions: Coronavirus
Coronavirus Infection
COVID-19

Registration Number: NCT04421508

Lead Sponsor: Bellerophon Pulse Technologies

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 191

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Number of Subjects Who Died or Had Respiratory Failure	Through Day 28	The number of subjects who died or had respiratory failure through Day 28

Secondary Outcome Measures

Name	Time	Method
Number of Subjects to Recover	Through Day 28	Number of subjects to recover, where recover is defined as attaining a NIAID Ordinal score of 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen or 8) Not hospitalized, no limitations on activities sustained through Day 28, or discharge from hospital without re admission for COVID.
Clinical Status Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale	Day 28	The assessment of clinical status at the first assessment of a study day. The scale is: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Number of Subjects Discharged Alive From Hospital	Through Day 28	Number of subjects discharged alive from hospital through Day 28
Duration of Hospitalization	Through Day 28	Duration of Hospitalization through Day 28
All Cause Mortality	Through Day 28	All cause mortality through Day 28
Difference in Proportion in RT-PCR Results at Discharge by Treatment Group	Through Day 28	Proportion of subjects with a positive RT-PCR result at baseline from a nasopharyngeal swab through Day 28 reported as a proportion of positive or negative RT-PCR testing.

Trial Locations

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
Scroll for more (7 remaining)
Banner University Medical Center
🇺🇸Phoenix, Arizona, United States