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

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

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Bellerophon Pulse Technologies

Study Contact

Valerie Parker
908-574-4713
valerie.parker@bellerophon.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.