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 @ 12:14 PM
Ignite Modification Date:
2025-12-24 @ 12:14 PM
NCT ID:
NCT04581161
Eligibility Criteria:
Inclusion Criteria:
Patients who meet all of the following inclusion criteria and no exclusion criteria will be included in the study:
* A diagnosed or suspected COVID-19 patient requiring non-invasive ventilatory support and admitted to hospital
* PaO2/FiO2 ≤ 300 (corrected for altitude)
* RR ≤ 30/min during early use of oxygen
* Adults of 18 years and older
* Provision of written informed consent to participate in study by subject or legal representative.
Exclusion Criteria:
Patients who meet one or more of the following exclusion criteria will not be eligible for the study:
* Patients under the age of 18
* Patients who are not diagnosed or suspected of having an acute COVID-19 illness
* Patients who do not require non-invasive ventilatory interventions, PaO2/FiO2 \> 300 (corrected for altitude) and tolerating supplemental oxygen with SpO2 saturations ≥ 92%.
* Patients who require immediate IMV upon admission or have a RR \> 30/min on early oxygen intervention.
* Thoracoabdominal desynchrony and paradoxical breathing at admission
* Patients in immediate need of or on vasopressors upon ICU admission
* Patients or legal representatives who are unwilling or unable to provide written consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04581161
Study Brief:
Protocol Section:
NCT04581161