Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-24 @ 3:32 PM
NCT ID:
NCT04476992
Eligibility Criteria:
Inclusion Criteria:
* COVID-19 confirmed by a positive RT-PCR test
* Hospital admission within 11 days from the onset of symptoms
* Spontaneous breathing with oxygen requirement ≥1 L/min
* Expected discharge \> 96 hours at randomization
Exclusion Criteria:
* Pregnancy
* Presence of a tracheostomy
* Assistance by any non-invasive CPAP or NIV at the screening
* Treatment with high flow nasal cannula at the screening
* Clinical contraindication to the use of NO
* Patients enrolled in another interventional trial
* Hospitalized and confirmed diagnosis of COVID-19 for more than 7 days
* Previous intubation for COVID-19
* Subject not committed to full support (DNR, DNI or CMO)
* Subject requiring oxygen at home for lung comorbidities
* The primary cause of hospitalization not due to COVID-19
* Subject receiving vasopressor at the time of screening
* History of malignancy or other irreversible disease/conditions with 6-month mortality \>50%
* Oxygen saturation of 100% at screening, despite oxygen requirement
* Patients on dialysis at the time of enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04476992
Study Brief:
Protocol Section:
NCT04476992