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

COVID-19 Clinical Trial

— COViNOX  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04421508
• Other study ID #: PULSE-CVD19-001
• Status: Terminated
• Phase: Phase 3
• Start date: July 12, 2020
• Est. completion date: January 22, 2021

Study information

• Verified date: January 2023
• Source: Bellerophon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 191
• Est. completion date: January 22, 2021
• Est. primary completion date: December 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infection
• Coronavirus Infections
• COVID-19

Intervention

Combination Product:
• INOpulse
Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.
• Placebo
Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.

Locations

Country	Name	City	State
United States	University of New Mexico Hospital	Albuquerque	New Mexico
United States	The Lung Research Center (St. Luke's)	Chesterfield	Missouri
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	INOVA	Falls Church	Virginia
United States	Houston Methodist	Houston	Texas
United States	University of Miami Health System	Miami	Florida
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Banner University Medical Center	Phoenix	Arizona
United States	Chippenham Medical Center	Richmond	Virginia
United States	Johnston-Willis Hospital	Richmond	Virginia
United States	Memorial Regional Medical Center	Richmond	Virginia
United States	Pulmonary Associates of Richmond	Richmond	Virginia
United States	St. Francis Medical Center	Richmond	Virginia
United States	St. Mary's Hospital	Richmond	Virginia
United States	Kaiser Permanente - San Diego Medical Center	San Diego	California
United States	Kaiser Permanente - Zion Medical Center	San Diego	California
United States	Mercy Health St. Vincent Medical Center	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Bellerophon Pulse Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Subjects With Adverse Events Leading to Study Drug Discontinuation	Number of subjects with adverse events leading to study drug discontinuation through Day 28	Through Day 28
Primary	The Number of Subjects Who Died or Had Respiratory Failure	The number of subjects who died or had respiratory failure through Day 28	Through Day 28
Secondary	Number of Subjects to Recover	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.	Through Day 28
Secondary	Clinical Status Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale	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.	Day 7
Secondary	Clinical Status Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale	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.	Day 14
Secondary	Clinical Status Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale	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.	Day 28
Secondary	Number of Subjects Discharged Alive From Hospital	Number of subjects discharged alive from hospital through Day 28	Through Day 28
Secondary	Duration of Hospitalization	Duration of Hospitalization through Day 28	Through Day 28
Secondary	All Cause Mortality	All cause mortality through Day 28	Through Day 28
Secondary	Difference in Proportion in RT-PCR Results at Discharge by Treatment Group	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.	Through Day 28