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:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT04377334
Eligibility Criteria:
Inclusion Criteria:
* COVID-19-positive subject
* Horowitz index ≤ 200
* Bilateral opacities on frontal chest radiograph, and
* requirement for positive pressure ventilation via an endotracheal tube or non-invasive ventilation
* no clinical signs of left atrial hypertension detected via echocardiography, or if measured, a Pulmonary Arterial Wedge Pressure (PAOP) less than or equal to 18 mmHg.
* Subject's Age ≥ 18 years
Exclusion Criteria:
* COVID-19-negative subject
* Subject's Age \< 18 years
* More than 7 days since initiation of mechanical ventilation
* Patient, surrogate or physician not committed to full intensive care support.
* Positive Pregnancy test at the time of screening.
* Patients dependent on the sponsor, investigator and their employees, as well as persons dependent on the manufacturer of the investigational drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04377334
Study Brief:
Protocol Section:
NCT04377334