iNOPulse for COVID-19
Withdrawn before enrolling · Phase 2 · Has a placebo group
Conditions studied: COVID-19, Hypoxemia, Hypoxemic Respiratory Failure
In brief
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.
Key facts
- Study ID
- NCT04398290
- Run by
- Roger Alvarez
- People needed
- 0
- Starts
- 2020-12-01
- Expected to finish
- 2021-07-15
- Last updated by the study team
- 2020-08-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University of Miami Hospitals & Clinics — Miami, Florida, United States
Full record on ClinicalTrials.gov
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