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 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT04412668
Eligibility Criteria:
Inclusion Criteria:
* Confirmation of SARS-CoV-2 infection by polymerase chain reaction (PCR).
* Severe pneumonia related to SARS-CoV-2 infection, defined as fever or suspected respiratory infection with radiographic abnormalities suggestive of viral pneumonia, plus at least 1 of the following:
* Respiratory rate \>30 breaths/minute;
* Severe respiratory distress, as determined by the Investigator;
* Oxygen saturation (SpO2) ≤93% on room air.
Exclusion Criteria:
* Participant is intubated/mechanically ventilated.
* In the opinion of the Investigator, participant's progression to death is imminent.
* Treatment with immunosuppressant/immunotherapy drugs, including but not limited to interleukin (IL)-6 inhibitors, tumor necrosis factor-alpha (TNF-α) inhibitors, anti-IL-1 agents and janus kinase inhibitors within 5 half-lives or 30 days prior to Day 1.
* Use of chronic (\>30 days) oral corticosteroids for a non-COVID-19-related condition in a dose higher than prednisone 10 mg or equivalent per day.
* Weight \>165 kg or \<40 kg.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04412668
Study Brief:
Protocol Section:
NCT04412668