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 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT04860518
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years
2. Positive SARS-CoV-2 test by PCR (polymerase chain reaction) or other diagnostic method within the past 7 days
3. Admission to hospital with respiratory symptoms of COVID-19 requiring hospital care and oxygen supplementation (≤ 8L/min)
4. Respiratory symptom onset no more than 7 days prior to hospital arrival
5. Informed consent from the subject or the subject's personal legal representative or a professional legal representative must be available
Exclusion Criteria:
1. Unable to screen, randomize and administer study drug within 48 hours from arrival to hospital
2. Systemic corticosteroid, baricitinib or tofacitinib (or other JAK-STAT signalling pathway inhibitors) therapy within 7 days prior to arrival to hospital or planned for the next days
3. Known hypersensitivity or contraindication to natural or recombinant IFN-beta-1a or its excipients, or to dexamethasone or its excipients
4. Currently receiving IFN-beta-1a therapy
5. Home assisted ventilation (via tracheotomy or non-invasive) except for Continuous Positive Airway Pressure (CPAP) / Bilevel Positive Airway Pressure (BIPAP) used only for sleep-disordered breathing
6. Participation in another concurrent interventional pharmacotherapy trial during the study period
7. Decision to withhold life-sustaining treatment; patient not committed to full support (except DNR after cardiac arrest only)
8. Woman known to be pregnant, lactating or with a positive pregnancy test (urine or serum test)
9. Subject is not expected to survive for 24 hours
10. Subject has liver failure (Child-Pugh grade C)
11. Any clinical condition that in the opinion of the attending clinician or Investigator would present a risk for the subject to participate in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04860518
Study Brief:
Protocol Section:
NCT04860518