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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT05224856
Eligibility Criteria:
Inclusion Criteria:
* Adult male or female patient, aged 18 or above.
* Patient diagnosed with SARS-CoV-2 infection at Screening by using the sponsor-supplied rapid SARS-CoV-2 diagnostic test or RT-PCR.
* Patient with conditions meeting all of the following criteria:
1. Oxygen saturation ≥ 94% on room air.
2. Not requiring supplemental oxygen.
* Patient who has onset of one or more of the SARS-CoV-2 infection associated symptoms within 7 days prior to the study drug administration.
Exclusion Criteria:
* Patient with current serious condition meeting one of the following:
1. Previously or currently hospitalized or requires hospitalization for treatment of serious SARS-CoV-2 related conditions.
2. Respiratory distress with respiratory rate ≥30 breaths/min.
3. Severe pneumonia
4. Requires supplemental oxygen
5. Experience shock
6. Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion.
* Patient who has received or has a plan to receive any of following prohibited medications or treatments:
1. Drugs with actual or possible antiviral drugs and/or possible anti-SARS-CoV-2 activity including but not limited to nirmatrelvir and ritonavir, molnupiravir, remdesivir, chloroquine, hydroxychloroquine, dexamethasone (or alternative corticosteroids to dexamethasone), and other immunomodulatory agents and human immunodeficiency virus protease inhibitors for therapeutic purpose of SARS-CoV-2 infection prior to study drug administration
2. Any SARS-CoV-2 human intravenous immunoglobulin, convalescent plasma for the treatment of COVID-19 infection prior to study drug administration
3. Any approved monoclonal antibody (sotrovimab, casirivimab and imdevimab, bamlanivimab and etesevimab, etc), any other investigational device or medical product including but not limited to any monoclonal antibody(tocilizumab, sarilumab, etc.), fusion proteins or biologics for the treatment of COVID-19 infection prior to the first study drug administration.
4. Any investigational vaccine for SARS-CoV-2.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05224856
Study Brief:
Protocol Section:
NCT05224856