iNOPulse for COVID-19

Roger Alvarez

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

COVID-19 Hypoxemia Hypoxemic Respiratory Failure

Interventions

Inhaled nitric oxide (iNO)DRUG

iNO Pulse 250 mcg/kg ideal body weight (IBW)/hour

Nitrogen gasDRUG

250 mcg/kg ideal body weight (IBW)/hour

Oxygen gasDRUG

Supplemental oxygen administered via nasal cannula

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Miami Hospitals & Clinics

Miami, Florida, United States

Outcomes

Primary Outcomes

Incidence of treatment emergent adverse events

As assessed per treating physician's discretion.

Time frame: Up to 14 days

Incidence of adverse events

Incidence of hypoxemia and hypotension as assessed per treating physician's discretion.

Time frame: Up to 6 hours

Incidence of methemoglobinemia

Incidence of increase to \> 5% total methemoglobin as assessed by pulse oximetry.

Time frame: Up to 14 days

Secondary Outcomes

Number of participants with progression of respiratory failure

Worsening respiratory status as defined by any one of the following: Implementation of High Flow Nasal Cannula (HFNC), non-rebreather mask, non-invasive ventilation, intubation and mechanical ventilation or need for intubation (in the event the patient is not intubated due to do not intubate (DNI) or do not resuscitate (DNR) status).

Time frame: Up to 14 days

Time until resolution of hypoxemia

The number of days until hypoxemia is resolved as per treating physician assessment

Time frame: Up to 14 days

Incidence of mortality

Incidence of death during hospitalization and after discharge up to 28 days

Time frame: Up to 28 days

Duration of hospitalization

Number of days of hospitalization

Time frame: Up to 28 days

Data from ClinicalTrials.gov

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