iNOPulse for COVID-19

Phase 2

Withdrawn

• Conditions: Hypoxemia; COVID-19; Hypoxemic Respiratory Failure
• Interventions: Drug: Inhaled nitric oxide (iNO); Drug: Nitrogen gas; Drug: Oxygen gas

• Registration Number: NCT04398290
• Lead Sponsor: Roger Alvarez

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-20
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-21
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-17
• Last Update Posted: 2020-08-19
• Study Start: 2020-12-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-07-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iNOpulse Treatment Group	Inhaled nitric oxide (iNO)	Participants in this group will receive iNO delivered continuously together with supplemental oxygen by nasal cannula during hospitalization for up to 28 days.
iNOpulse Treatment Group	Oxygen gas	Participants in this group will receive iNO delivered continuously together with supplemental oxygen by nasal cannula during hospitalization for up to 28 days.
Placebo Group	Nitrogen gas	Participants in this group will receive nitrogen gas delivered continuously together with supplemental oxygen by nasal cannula during hospitalization for up to 28 days
Placebo Group	Oxygen gas	Participants in this group will receive nitrogen gas delivered continuously together with supplemental oxygen by nasal cannula during hospitalization for up to 28 days

Primary Outcome Measures

Name	Time	Method
Incidence of treatment emergent adverse events	Up to 14 days	As assessed per treating physician's discretion.
Incidence of adverse events	Up to 6 hours	Incidence of hypoxemia and hypotension as assessed per treating physician's discretion.
Incidence of methemoglobinemia	Up to 14 days	Incidence of increase to \> 5% total methemoglobin as assessed by pulse oximetry.

Secondary Outcome Measures

Name	Time	Method
Number of participants with progression of respiratory failure	Up to 14 days	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 until resolution of hypoxemia	Up to 14 days	The number of days until hypoxemia is resolved as per treating physician assessment
Incidence of mortality	Up to 28 days	Incidence of death during hospitalization and after discharge up to 28 days
Duration of hospitalization	Up to 28 days	Number of days of hospitalization

Trial Locations

Locations (1)

University of Miami Hospitals & Clinics; 🇺🇸 Miami, Florida, United States