A Study to Assess Pulsed Inhaled Nitric Oxide vs Placebo in Subjects With Mild or Moderate COVID-19
Purpose
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.
Conditions
- COVID-19
- Coronavirus
- Coronavirus Infection
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator Inhaled Nitric Oxide (iNO) |
Pulsed inhaled iNO 125 mcg/kg IBW/hour |
|
Sham Comparator Placebo |
Pulsed inhaled N2, 99.999% gas |
|
Recruiting Locations
More Details
- NCT ID
- NCT04421508
- Status
- Terminated
- Sponsor
- Bellerophon Pulse Technologies
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.