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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Age 18 or above 2. Proven COVID-19 viral infection. Non-confirmed highly suspicious suspects may be enrolled. 3. Presence of radiographic findings compatible with pneumonia/pneumonitis. 4. Patients requiring at least 3 L/m oxygen via nasal canula to maintain O2 above 92%. 5. Female subjects of childbearing potential must have a negative pre-treatment pregnancy test (serum or urine). 6. Willing and able to comply with treatment schedule and study procedures.

Exclusion Criteria

  1. 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. 2. Participating in any other clinical trial for COVID-19 3. Pregnancy, or positive pregnancy test in a pre-dose examination. 4. Open tracheostomy. 5. Clinical contra-indication, as deemed by the PI or their designee. 6. 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. 7. Known history or clinical evidence of heart failure or left ventricular dysfunction (LVEF < 45%). 8. Significant hemoptysis 9. Unable to provide informed consent (proxy consent is acceptable if available) 10. 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
iNOpulse Treatment Group 		Participants in this group will receive iNO delivered continuously together with supplemental oxygen by nasal cannula during hospitalization for up to 28 days.
  • Drug: Inhaled nitric oxide (iNO)
    iNO Pulse 250 mcg/kg ideal body weight (IBW)/hour
  • Drug: Oxygen gas
    Supplemental oxygen administered via nasal cannula
Active Comparator
Placebo Group 		Participants in this group will receive nitrogen gas delivered continuously together with supplemental oxygen by nasal cannula during hospitalization for up to 28 days
  • Drug: Nitrogen gas
    250 mcg/kg ideal body weight (IBW)/hour
  • Drug: Oxygen gas
    Supplemental oxygen administered via nasal cannula

Recruiting Locations

More Details

NCT ID
NCT04398290
Status
Withdrawn
Sponsor
Roger Alvarez

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.