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 @ 12:06 PM
Ignite Modification Date:
2025-12-24 @ 12:06 PM
NCT ID:
NCT04760561
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18-75 years old
2. Awake non-intubated spontaneously breathing patients
3. Confirmed diagnosis of severe COVID-19; manifesting as dyspnea with respiratory rate ≥ 30 breaths/min, pulse rate ≥ 100 beats/min, oxygen saturation ≤93%, or partial pressure of arterial oxygen (PaO2) to fraction of inspired oxygen (FiO2) ratio ≤ 150 mmHg.
4. Positive RT-PCR for SARS-CoV-2 from analysis of nasopharyngeal, oropharyngeal swab, or tracheal secretion specimens and with chest X-ray showing bilateral infiltrations or chest computerized tomographic (CT) images showing exudation or consolidation.
5. Requiring supplemental oxygen (nasal cannula, non-invasive CPAP, non-rebreathing face mask)
6. Capable of adopting a prone posture independently.
Exclusion Criteria:
The presence of any of the following will mean patients are ineligible:
1. life-threatening arrhythmias
2. Hemodynamic instability (defined as mean arterial pressure \[MAP\] \< 65mm Hg and use of vasopressors to achieve MAP \> 65 mm Hg)
3. Altered mental status, intracranial hypertension
4. Facial injuries
5. Spine or pelvic fractures
6. Recent abdominal surgery
7. Pregnancy
8. Altered mental status and patients needing invasive ventilation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04760561
Study Brief:
Protocol Section:
NCT04760561