Uncomplicated influenza A and B
Conditions
Interventions
Suraxavir Marboxil Tablets Group:Mashulavir single dose administration
oseltamivir:Continuous administration of oseltamivir phosphate for 5 days
Sponsors
Beijing Ditan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subject and/or guardian signs the informed consent form; 2. Age >=12 years old, male or female; 3. Confirmed influenza virus infection by the following criteria: (1) Positive throat swab or nasal swab by influenza rapid antigen test (RAT) (of which rapid influenza virus nucleic acid test or other rapid molecular diagnostic methods are also acceptable); and (2) fever (axillary temperature>=37.3°C) at screening; (3) At least one systemic symptom and respiratory symptom related to influenza virus infection at screening; 4. The interval between symptom onset and first medication <=48 hours; 5. Subjects whose parents/guardians are willing and able to comply with the requirements of the study in the opinion of the investigator and are able to achieve a level of understanding to comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to the active ingredients or excipients of the investigational drug; 2. Patients with severe influenza who need to be hospitalized; 3. Body weight<=40 kg; 4. Pregnant and perinatal women; 5. Patients with serious non-infectious pulmonary underlying diseases, including: tuberculosis, lung tumors, pulmonary edema, atelectasis, pulmonary embolism, pulmonary eosinophilic infiltrates and pulmonary vasculitis; 6. Severe liver and kidney dysfunction: (1) ALT and AST exceed the upper limit of normal value by more than 5 times; (2) The blood creatinine value exceeds the upper limit of normal value by more than 1.5 times; 7. Patients with poorly controlled chronic underlying diseases, such as liver cirrhosis, cardiovascular disease, diabetes, active tumors, immunocompromised (such as CD4 less than 200/µL); 8. Those who are receiving systemic glucocorticoid therapy or immunosuppressive therapy; 9. Patients with other bacterial or viral infections requiring medication; 10. Received any influenza antiviral drug treatment within 30 days before screening (including: neuraminidase inhibitors, hemagglutinin inhibitors and M2 ion channel blockers, such as: oseltamivir, zanamivir, peramivir, favipiravir, abidol, mabaloxavir, amantadine or amantadine, etc.); 11. Recent (within 1 month) influenza vaccination; 12. Subjects who are judged by the investigator to be unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to alleviation of infuenza symptoms (TTAS);Times to fever resolution;Adverse event; | — |
Countries
China
Contacts
Public ContactJiang Rongmeng
Beijing Ditan Hospital, Capital Medical University
Outcome results
None listed