Clinical trial NCT04398290: iNOPulse for COVID-19
Official title: Randomized Controlled Trial Of A Delivered Continuously By Nasal Cannula For The Treatment Of Patients With COVID-19 And Mild To Moderate Hypoxemia Requiring Supplemental Oxygen
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: COVID-19
Hypoxemia
Hypoxemic Respiratory Failure
Keywords: hypoxemia
respiratory failure
COVID-19
inhaled nitric oxide
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Bellerophon Therapeutics
First posted: 2020-05-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Incidence of treatment emergent adverse events
timeFrame: Up to 14 days
measure: Incidence of adverse events
timeFrame: Up to 6 hours
measure: Incidence of methemoglobinemia
timeFrame: Up to 14 days
Secondary outcomes:
measure: Number of participants with progression of respiratory failure
timeFrame: Up to 14 days
measure: Time until resolution of hypoxemia
timeFrame: Up to 14 days
measure: Incidence of mortality
timeFrame: Up to 28 days
measure: Duration of hospitalization
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Hospitals & Clinics
state: Florida
Study officials:
affiliation: University of Miami
name: Roger A Alvarez, D.O.
role: PRINCIPAL_INVESTIGATOR
References: