iNOPulse for COVID-19

COVID-19 Clinical Trial

— NO-COVER  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04398290
• Other study ID #: 20200449
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 1, 2020
• Est. completion date: July 15, 2021

Study information

• Verified date: August 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 15, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Hypoxemia
• Hypoxemic Respiratory Failure
• Hypoxia
• Respiratory Insufficiency

Intervention

Drug:
• Inhaled nitric oxide (iNO)
iNO Pulse 250 mcg/kg ideal body weight (IBW)/hour
• Nitrogen gas
250 mcg/kg ideal body weight (IBW)/hour
• Oxygen gas
Supplemental oxygen administered via nasal cannula

Locations

Country	Name	City	State
United States	University of Miami Hospitals & Clinics	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Roger Alvarez	Bellerophon Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment emergent adverse events	As assessed per treating physician's discretion.	Up to 14 days
Primary	Incidence of adverse events	Incidence of hypoxemia and hypotension as assessed per treating physician's discretion.	Up to 6 hours
Primary	Incidence of methemoglobinemia	Incidence of increase to > 5% total methemoglobin as assessed by pulse oximetry.	Up to 14 days
Secondary	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).	Up to 14 days
Secondary	Time until resolution of hypoxemia	The number of days until hypoxemia is resolved as per treating physician assessment	Up to 14 days
Secondary	Incidence of mortality	Incidence of death during hospitalization and after discharge up to 28 days	Up to 28 days
Secondary	Duration of hospitalization	Number of days of hospitalization	Up to 28 days