Status:
WITHDRAWN
iNOPulse for COVID-19
Lead Sponsor:
Roger Alvarez
Collaborating Sponsors:
Bellerophon Therapeutics
Conditions:
COVID-19
Hypoxemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This randomized, controlled trial will assess the efficacy and safety of pulsed iNO in subjects with COVID-19 who are hospitalized and require supplemental oxygen.
Eligibility Criteria
Inclusion
- Age 18 or above
- Proven COVID-19 viral infection. Non-confirmed highly suspicious suspects may be enrolled.
- Presence of radiographic findings compatible with pneumonia/pneumonitis.
- Patients requiring at least 3 L/m oxygen via nasal canula to maintain O2 above 92%.
- Female subjects of childbearing potential must have a negative pre-treatment pregnancy test (serum or urine).
- Willing and able to comply with treatment schedule and study procedures.
Exclusion
- Patient with severe hypoxemia who are unable to maintain an oxygen saturation (SpO2) \> 88% on a maximum supplemental oxygen of 6 L/m by nasal cannula and a non-rebreather facemask.
- Participating in any other clinical trial for COVID-19
- Pregnancy, or positive pregnancy test in a pre-dose examination.
- Open tracheostomy.
- Clinical contra-indication, as deemed by the PI or their designee.
- Use of a nitric oxide donor agent such as nitroglycerin or drugs known to increase methemoglobin such as intravenous lidocaine, or topical benzocaine or dapsone at screening.
- Known history or clinical evidence of heart failure or left ventricular dysfunction (LVEF \< 45%).
- Significant hemoptysis
- Unable to provide informed consent (proxy consent is acceptable if available)
- Any of the following conditions at time of possible enrollment: Fulminant Liver Failure, Acute Coronary Syndrome , Renal Failure requiring dialysis, Bacteremia, Shock, Cardiac arrest, Cardiac arrhythmia requiring acute treatment, Delirium / Encephalopathy, Severe Disseminated Intravascular Coagulation, Gastrointestinal hemorrhage, Hypoglycemia, Pneumothorax, Rhabdomyolysis / Myositis, Seizures, or Acute Stroke
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04398290
Start Date
December 1 2020
End Date
July 15 2021
Last Update
August 19 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Miami Hospitals & Clinics
Miami, Florida, United States, 33125