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 @ 11:59 PM
Ignite Modification Date:
2025-12-24 @ 11:59 PM
NCT ID:
NCT04290858
Eligibility Criteria:
Inclusion Criteria:
1. Laboratory confirmed COVID19 infection defined with a positive RT-PCR from any specimen.
2. Hospital admission with at least one of the following:
* fever ≥ 36.6 °C from axillary site; or ≥ 37.2°C from oral site; or ≥ 37.6°C from tympanic or rectal site.
* Respiratory rate ≥ 24 bpm
* cough
3. Spontaneous breathing with or without hypoxia of any degree. Gas exchange and ventilation maybe assisted by any continuous continuous airway pressure (CPAP), or any system of Non Invasive Ventilation (NIV), with Positive End-Expiratory Pressure (PEEP) ≤ 10 cmH2O.
4. ≤ 8 days since onset of the symptoms
Exclusion Criteria:
1. Pregnancy, or positive pregnancy test in a predose examination
2. Open tracheostomy
3. Therapy with high flow nasal cannula
4. Clinical controindication, as deemed by the attending physician
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04290858
Study Brief:
Protocol Section:
NCT04290858