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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04421508
Recruitment Status : Terminated (Futility)
First Posted : June 9, 2020
Results First Posted : February 1, 2023
Last Update Posted : February 21, 2023
Sponsor:
Information provided by (Responsible Party):
Bellerophon ( Bellerophon Pulse Technologies )

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Coronavirus Coronavirus Infection Combination Product: INOpulse Combination Product: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 191 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : July 12, 2020
Actual Primary Completion Date : December 28, 2020
Actual Study Completion Date : January 22, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Inhaled Nitric Oxide (iNO)
Pulsed inhaled iNO 125 mcg/kg IBW/hour
 Combination Product: INOpulse
Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.
Sham Comparator: Placebo
Pulsed inhaled N2, 99.999% gas
 Combination Product: Placebo
Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.


Outcome Measures
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Primary Outcome Measures :
  1. The Number of Subjects Who Died or Had Respiratory Failure [ Time Frame: Through Day 28 ]
    The number of subjects who died or had respiratory failure through Day 28


Secondary Outcome Measures :
  1. Number of Subjects to Recover [ Time Frame: 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.

  2. Clinical Status Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale [ Time Frame: Day 7 ]
    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.

  3. Clinical Status Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale [ Time Frame: Day 14 ]
    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.

  4. Clinical Status Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale [ Time Frame: 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.

  5. Number of Subjects Discharged Alive From Hospital [ Time Frame: Through Day 28 ]
    Number of subjects discharged alive from hospital through Day 28

  6. Duration of Hospitalization [ Time Frame: Through Day 28 ]
    Duration of Hospitalization through Day 28

  7. All Cause Mortality [ Time Frame: Through Day 28 ]
    All cause mortality through Day 28

  8. Difference in Proportion in RT-PCR Results at Discharge by Treatment Group [ Time Frame: 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.


Other Outcome Measures:
  1. Number of Subjects With Adverse Events Leading to Study Drug Discontinuation [ Time Frame: Through Day 28 ]
    Number of subjects with adverse events leading to study drug discontinuation through Day 28


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04421508


Locations
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Sponsors and Collaborators
Bellerophon Pulse Technologies
Investigators
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Study Director: Ashika Ahmed, MD Bellerophon Therapeutics
  Study Documents (Full-Text)

Documents provided by Bellerophon ( Bellerophon Pulse Technologies ):
Study Protocol  [PDF] August 19, 2020
Statistical Analysis Plan  [PDF] October 26, 2020

More Information
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Responsible Party: Bellerophon Pulse Technologies
ClinicalTrials.gov Identifier: NCT04421508    
Other Study ID Numbers: PULSE-CVD19-001
First Posted: June 9, 2020    Key Record Dates
Results First Posted: February 1, 2023
Last Update Posted: February 21, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bellerophon ( Bellerophon Pulse Technologies ):
COVID
Sars-CoV-2
iNO
INOpulse
Severe Acute Respiratory Syndrome (SARS) Pneumonia
Severe Acute Respiratory Syndrome Coronavirus 2
 SARS-CoV 2
COViNOX
pulsed inhaled nitric oxide
inhaled nitric oxide
portable pulsed inhaled nitric oxide
nitric oxide
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
 Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases