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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT07229820
Eligibility Criteria:
Inclusion Criteria:
1. Participants and their guardians who are able to understand the study and comply with all study procedures, and willing to provide written informed consent/assent prior to the predose examinations appropriately.
2. Male or female participants aged ≥ 2 to ≤11 years at the time of signing the informed consent form.
3. Participants with a diagnosis of influenza virus infection confirmed by all of the following:
1. Positive rapid antigen test (RAT) for influenza with nasal or throat swabs;
2. The time interval between the onset of symptoms and enrollment is 48 hours or less;
3. Fever ≥ 38ºC (axillary temperature); and at least one following respiratory symptoms associated with influenza virus infection is present
Exclusion Criteria:
1. Participants with severe influenza virus infection；
2. Participants with any medical history in gastrointestinal that interferes with the absorption of drugs；
3. Immunodeficiency,including malignant tumor,organ or marrow transplant,human immunodeficiency virus \[HIV\] infection,or patients receiving immunosuppressant therapy 3 months prior to enrollment；
4. Have received any other investigational products within 3 months prior to dosing；
5. Positive urine pregnancy test；
6. Participants with concurrent infections requiring antimicrobial therapy；
7. Participants who are considered inappropriate for the study by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT07229820
Study Brief:
Protocol Section:
NCT07229820