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A Study to Assess Pulsed Inhaled Nitric Oxide vs Placebo in Subjects With Mild or Moderate COVID-19
COViNOX
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)
1 other identifier
interventional
191
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 covid19
Started Jul 2020
Shorter than P25 for phase_3 covid19
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedStudy Start
First participant enrolled
July 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 22, 2021
CompletedResults Posted
Study results publicly available
February 1, 2023
CompletedFebruary 21, 2023
January 1, 2023
6 months
June 5, 2020
May 30, 2022
February 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Number of Subjects to Recover
Through Day 28
Clinical Status Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale
Day 7
Clinical Status Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale
Day 14
Clinical Status Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale
Day 28
Number of Subjects Discharged Alive From Hospital
Through Day 28
- +3 more secondary outcomes
Other Outcomes (1)
Number of Subjects With Adverse Events Leading to Study Drug Discontinuation
Through Day 28
Study Arms (2)
Inhaled Nitric Oxide (iNO)
ACTIVE COMPARATORPulsed inhaled iNO 125 mcg/kg IBW/hour
Placebo
SHAM COMPARATORPulsed inhaled N2, 99.999% gas
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Banner University Medical Center
Phoenix, Arizona, 85006, United States
Kaiser Permanente - Zion Medical Center
San Diego, California, 92120, United States
Kaiser Permanente - San Diego Medical Center
San Diego, California, 92123, United States
University of Miami Health System
Miami, Florida, 33136, United States
The Lung Research Center (St. Luke's)
Chesterfield, Missouri, 63017, United States
University of New Mexico Hospital
Albuquerque, New Mexico, 87106, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Mercy Health St. Vincent Medical Center
Toledo, Ohio, 43608, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Houston Methodist
Houston, Texas, 77030, United States
INOVA
Falls Church, Virginia, 22042, United States
St. Francis Medical Center
Richmond, Virginia, 23114, United States
Memorial Regional Medical Center
Richmond, Virginia, 23116, United States
Chippenham Medical Center
Richmond, Virginia, 23225, United States
Pulmonary Associates of Richmond
Richmond, Virginia, 23226, United States
St. Mary's Hospital
Richmond, Virginia, 23226, United States
Johnston-Willis Hospital
Richmond, Virginia, 23235, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bobae Kim
- Organization
- Bellerophon Therapeutics
Study Officials
- STUDY DIRECTOR
Ashika Ahmed, MD
Bellerophon Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2020
First Posted
June 9, 2020
Study Start
July 12, 2020
Primary Completion
December 28, 2020
Study Completion
January 22, 2021
Last Updated
February 21, 2023
Results First Posted
February 1, 2023
Record last verified: 2023-01