Influenza A virus infection
Conditions
Interventions
baloxavir marboxil:Baloxavir Marboxil, 40-80mg/dose, taken orally once
Short-course Onradivir Tablets versus:Onradivir Tablets, 0.6g per dose, once daily, for 3 consecutive days
Standard-course Onradivir Tablets:Onradivir Tablets, 0.6g per dose, once daily, for 5 consecutive days
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged >= 18 years , regardless of gender. 2.Voluntarily sign the informed consent form and have a full understanding of the study content, procedures, and possible adverse reactions. 3.Diagnosed with influenza A virus infection in accordance with the following criteria: (1) Positive rapid antigen test (RAT) (influenza virus nucleic acid testing or other rapid molecular diagnostic methods at the study site are also acceptable); (2) Fever at screening (axillary temperature >= 37.3 °C); (3) Accompanied by at least one moderate or higher respiratory symptom (cough, sore throat, nasal congestion). 4.Time interval from onset of influenza symptoms = 37.3 °C, or the appearance of at least one systemic or respiratory symptom). 5.The subject or their legal guardian is able to cooperate and complete ePRO reporting.
Exclusion criteria
Exclusion criteria: 1. Subjects with severe underlying diseases including serious cardiac, hepatic, renal, pulmonary, hematological and other systemic disorders, or those deemed by the investigator to have significant safety risks and thus unsuitable for participation. 2. Pregnant or lactating females. 3. Severe or critical influenza subjects requiring hospitalization. 4. Use of anti-influenza A antiviral agents within 30 days prior to enrollment. 5. Participation in other interventional studies within 30 days prior to enrollment. 6. Any other conditions deemed inappropriate for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to alleviation of symptoms; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of antigen conversion to negative;Time to improvement of systemic/respiratory symptoms;Influenza infection status of household contacts;Influenza-related emergency/hospitalization rate and revisit rate (14 or 30 days);Incidence of complications (14 or 30 days);Time to improvement of various influenza symptoms;Rate of Influenza Symptom Relief at Each Time Point;Time to fever resolution;Antibiotic use requirement: The proportion of study participants who require systemic antibiotics due to influenza secondary infection.; | — |
Countries
China
Contacts
Public ContactZhong Nanshan
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed