Last Verified: | June/30/2020 |
First Submitted: | July/15/2020 |
Estimated Enrollment Submitted: | July/15/2020 |
First Posted: | July/19/2020 |
Last Update Submitted: | July/15/2020 |
Last Update Posted: | July/19/2020 |
Actual Study Start Date: | July/16/2020 |
Estimated Primary Completion Date: | July/16/2021 |
Estimated Study Completion Date: | September/16/2021 |
Study Type: | Interventional |
Allocation: | Randomized |
Primary Purpose: | Treatment |
Masking: | Single (Outcomes Assessor) |
Arm | Intervention/treatment |
---|---|
Active Comparator: NO High Concentration Nitric oxide will be delivered twice a day with a non-rebreathing system that allows a safe administration of Nitric Oxide gas at high concentrations limiting the amount of NO2 delivered to the patient. | Drug: NO High Concentration Nitric Oxide will be delivered at 200 ppm in 2 daily sessions (morning, evening; 9-12 hours apart) for 14 days. Each session will last 30 minutes, for a total of 60 minutes/day for each patient. A tank of NO gas will be connected to the inspiratory limb of the circuit, and the flow will be adjusted to deliver a target concentration of 200 ppm NO. Commercially available tanks will be used to provide the gas. The desired mixture of air, oxygen (O2), and NO will be titrated with the respective flowmeter to reach a concentration of 200 ppm at the inspiratory limb with the desired Fraction of inspired oxygen (FiO2). |
Experimental: NO High Concentration + Continuous Low Concentration Nitric oxide will be delivered twice a day with a non-rebreathing system that allows a safe administration of Nitric Oxide gas at high concentrations limiting the amount of NO2 delivered to the patient. This arm will receive in addition a continuous low flow of Nitric Oxide at 20 ppm among the high concentration treatments. | Drug: NO High Concentration + Continuous Low Concentration Nitric Oxide will be delivered at 200 ppm in 2 daily sessions (morning, evening; 9-12 hours apart) for 14 days. Each session will last 30 minutes, for a total of 60 minutes/day for each patient. A tank of NO gas will be connected to the inspiratory limb of the circuit, and the flow will be adjusted to deliver a target concentration of 200 ppm NO. Commercially available tanks will be used to provide the gas. The desired mixture of air, oxygen (O2), and NO will be titrated with the respective flowmeter to reach a concentration of 200 ppm at the inspiratory limb with the desired Fraction of inspired oxygen (FiO2). The subjects assigned to the group "NO High Concentration + Continuous Low Concentration" will receive in adjunction a continuous dose of NO at 20 ppm. |
Ages Eligible for Study: | 18 Years to 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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 |