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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04421508
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Bellerophon ( Bellerophon Pulse Technologies )

Tracking Information
First Submitted Date  ICMJE June 5, 2020
First Posted Date  ICMJE June 9, 2020
Last Update Posted Date September 9, 2020
Actual Study Start Date  ICMJE July 12, 2020
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2020)
The proportion of subjects who died or had respiratory failure [ Time Frame: Through Day 28 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2020)
  • Clinical status using National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal scale [ Time Frame: Day 7, 14, 28 and day of discharge ]
    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.
  • Proportion of subject to recover, defined as return to room air or baseline O2, or discharged alive [ Time Frame: Through Day 28 ]
  • Proportion of subjects discharged alive from hospital [ Time Frame: Through Day 28 ]
  • Duration of Hospitalization [ Time Frame: Through Day 28 ]
  • Mortality - all cause and cardiopulmonary [ Time Frame: Through Day 28 ]
  • Proportion of subjects with a negative conversion of reverse transcription polymerase chain reaction (RT-PCR) from a nasopharyngeal swab [ Time Frame: Through Day 28 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2020)
  • 8-point NIAID ordinal scale [ Time Frame: Day 7, 14, 28 ]
  • Proportion of subject to recover, defined as return to room air or baseline O2, or discharged alive [ Time Frame: Through Day 28 ]
  • Proportion of subjects discharged alive from hospital [ Time Frame: Through Day 28 ]
  • Duration of Hospitalization [ Time Frame: Through Day 28 ]
  • Mortality - all cause and cardiopulmonary [ Time Frame: Through Day 28 ]
  • Proportion of subjects with a negative conversion of reverse transcription polymerase chain reaction (RT-PCR) from a nasopharyngeal swab [ Time Frame: Through Day 28 ]
Current Other Pre-specified Outcome Measures
 (submitted: June 5, 2020)
Proportion of subjects with adverse events leading to study drug discontinuation [ Time Frame: Through Day 28 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study to Assess Pulsed Inhaled Nitric Oxide vs Placebo in Subjects With Mild or Moderate COVID-19
Official Title  ICMJE 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19
  • Coronavirus
  • Coronavirus Infection
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Inhaled Nitric Oxide (iNO)
    Pulsed inhaled iNO 125 mcg/kg IBW/hour
    Intervention: Combination Product: INOpulse
  • Sham Comparator: Placebo
    Pulsed inhaled N2, 99.999% gas
    Intervention: Combination Product: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 5, 2020)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Valerie Parker 908-574-4713 valerie.parker@bellerophon.com
Contact: Michelle Alamo 908-574-4768 michelle.alamo@bellerophon.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04421508
Other Study ID Numbers  ICMJE PULSE-CVD19-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bellerophon ( Bellerophon Pulse Technologies )
Study Sponsor  ICMJE Bellerophon Pulse Technologies
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Wassim Fares, MD MSc Bellerophon Pulse Technologies
PRS Account Bellerophon
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP