A Study to Assess Pulsed Inhaled Nitric Oxide vs Placebo in Subjects With Mild or Moderate COVID-19 (COViNOX)
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| ClinicalTrials.gov Identifier: NCT04421508 |
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Recruitment Status :
Recruiting
First Posted : June 9, 2020
Last Update Posted : September 9, 2020
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Sponsor:
Bellerophon Pulse Technologies
Information provided by (Responsible Party):
Bellerophon ( Bellerophon Pulse Technologies )
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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 |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 500 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 |
| Estimated Primary Completion Date : | February 2021 |
| Estimated Study Completion Date : | June 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Coronavirus Infections
Drug Information available for:
Nitric oxide
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Inhaled Nitric Oxide (iNO)
Pulsed inhaled iNO 125 mcg/kg IBW/hour
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Combination Product: INOpulse
Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula. |
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Sham Comparator: Placebo
Pulsed inhaled N2, 99.999% gas
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Combination Product: Placebo
Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula. |
Primary Outcome Measures :
- The proportion of subjects who died or had respiratory failure [ Time Frame: Through Day 28 ]
Secondary Outcome Measures :
- 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 ]
Other Outcome Measures:
- Proportion of subjects with adverse events leading to study drug discontinuation [ Time Frame: Through Day 28 ]
Information from the National Library of Medicine
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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
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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
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
Contacts
| Contact: Valerie Parker | 908-574-4713 | valerie.parker@bellerophon.com | |
| Contact: Michelle Alamo | 908-574-4768 | michelle.alamo@bellerophon.com |
Locations
Show 17 study locations
Sponsors and Collaborators
Bellerophon Pulse Technologies
Investigators
| Study Director: | Wassim Fares, MD MSc | Bellerophon Pulse Technologies |
| Responsible Party: | Bellerophon Pulse Technologies |
| ClinicalTrials.gov Identifier: | NCT04421508 |
| Other Study ID Numbers: |
PULSE-CVD19-001 |
| First Posted: | June 9, 2020 Key Record Dates |
| Last Update Posted: | September 9, 2020 |
| Last Verified: | September 2020 |
| 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 ):
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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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Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Tract Diseases Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections |