Nitric Oxide Therapy for COVID-19 Patients With Oxygen Requirement

• Status: Active, not recruiting
• Trial end date: 2021-09-17
• Target enrollment: 0
• Participant gender: All

Summary

Preliminary data support the effect of Nitric Oxide (NO) on improving the oxygenation in mechanically ventilated patients and spontaneously breathing patients with COVID-19. In vitro studies showed an antiviral effect of NO against SARS-coronavirus. The optimal therapeutic regimen of NO gas in spontaneously breathing hypoxemic patients with COVID-19 is not known. We hypothesize that high concentration inhaled NO with an adjunct of continuous low dose administration between the high concentration treatments can be safely administered in hypoxemic COVID-19 patients compared to the high dose treatment alone. Prolonged administration of NO gas may benefit the patients in terms of the severity of the clinical course and time to recovery. Together with a clinical effect on ventilation-perfusion matching, a prolonged regimen would allow also an increase in antiviral activity (dose and time-dependent).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal State Budgetary Scientific Institution, Research Institute of Cardiology; Tomsk National Research Medical Center of the Russian Academy of Sciences
• Collaborator: Siberian State Medical University
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

1. COVID-19 confirmed by a positive RT-PCR test

2. Hospital admission within 11 days from the onset of symptoms

3. Spontaneous breathing with oxygen requirement ≥1 L/min

4. Expected discharge > 96 hours at randomization

Exclusion Criteria:

1. Pregnancy

2. Presence of a tracheostomy

3. Assistance by any non-invasive CPAP or NIV at the screening

4. Treatment with high flow nasal cannula at the screening

5. Clinical contraindication to the use of NO

6. Patients enrolled in another interventional trial

7. Hospitalized and confirmed diagnosis of COVID-19 for more than 7 days

8. Previous intubation for COVID-19

9. Subject not committed to full support (DNR, DNI or CMO)

10. Subject requiring oxygen at home for lung comorbidities

11. The primary cause of hospitalization not due to COVID-19

12. Subject receiving vasopressor at the time of screening

13. History of malignancy or other irreversible disease/conditions with 6-month mortality >50%

14. Oxygen saturation of 100% at screening, despite oxygen requirement

15. Patients on dialysis at the time of enrollment