Status:
TERMINATED
A Study to Assess Pulsed Inhaled Nitric Oxide vs Placebo in Subjects With Mild or Moderate COVID-19
Lead Sponsor:
Bellerophon Pulse Technologies
Conditions:
COVID-19
Coronavirus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2021
Estimated Enrollment :
191 Patients enrolled
Trial Details
Trial ID
NCT04421508
Start Date
July 12 2020
End Date
January 22 2021
Last Update
February 21 2023
Active Locations (17)
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1
Banner University Medical Center
Phoenix, Arizona, United States, 85006
2
Kaiser Permanente - Zion Medical Center
San Diego, California, United States, 92120
3
Kaiser Permanente - San Diego Medical Center
San Diego, California, United States, 92123
4
University of Miami Health System
Miami, Florida, United States, 33136