Clinical Trials in China / NCT07229820
Active, not recruiting
Phase 3
Efficacy and Safety of ZSP1273 in Children 12-17 Years Old With Influenza A
NCT07229820 · tracked via the Priya Life Science China tracker
Condition(s) studied
Influenza A
Investigational drug(s) / intervention(s)
ZSP1273Placebo
ZSP1273: Oral
Placebo: Oral
Study summary
This trial is conducted in China. This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of ZSP1273 in the treatment of Acute Uncomplicated influenza A in adolescents.
Eligibility
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.
Primary outcome measure(s)
- Time to Alleviation of Symptoms — DAY1~DAY15
Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Ruijin Hospital | Shanghai | China |
More Guangdong Raynovent Biotech Co., Ltd trials in China
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07229820 on ClinicalTrials.gov ↗ ← All trials in China