Influenza
Conditions
Interventions
the experimental group (TG-1000):All adults and adolescents were randomly assigned. They receive the study drug with a single oral dose with approximately 240 mL of water on Day 1. Doses are calculate
the control group (placebo):All adults and adolescents were randomly assigned. They receive the study drug with a single oral dose with approximately 240 mL of water on Day 1. Doses are calculated bas
Sponsors
No. 28, Qiaozhong Middle Road, Liwan District, Guangzhou
Eligibility
Sex/Gender
All
Age
12 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Subjects who fulfill all of the following criteria will be included in the study: 1. Adult subjects who provide written informed consent to participate in the study on a voluntary basis; For Adolescent subjects, written informed consent of voluntary participation should be obtained from adolescent subjects and their guardians; 2. Subjects aged >= 12 and = 38·0 °C during the screening or feverishness = 38·0 °C after antipyretics more than 4 h if they are taken; (2) At least one systematic symptom and at least one respiratory symptom related to influenza onset with a severity of moderate or greater. ? The systematic symptoms include headache, feverishness or chills, muscle or joint pain, fatigue. ? The respiratory symptoms include cough, sore throat, nasal congestion. 4. Theinterval between the onset of symptoms and randomization = 38·0 °C ); (2) Time when the subject experiences at least one general or respiratory symptom: a. cough, b. sore throat, c. nasal congestion, d. headache, e. feverishness or chills, f. fatigue, g. muscle or joint pain. 5. Female subjects had to be identified: (1) Not pregnant, postpartum, or breastfeeding; (2) Infertile (i.e. women with previous hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or medically documented ovarian failure, or menopausal and aged > 50 years , amenorrhea ( >= 12 months), or (3) Women who are fertile (i.e. no hysterectomy, unilateral salpingectomy, unilateral oophorectomy, women with ovarian failure without medical documentation; Amenorrhea women aged <= 50 years will be considered fertile). Women must be pregnancy test negative during screening. They also had to meet one of the following criteria from screening until 30 days after the end of study drug administration: ? Complete abstinence. Periodic abstinence (e.g. calendar method, ovulation method, symptomatic temperature method, safe period method after ovulation) is not acceptable. Or ? Continued use of one of the following contraceptive methods and male partners use condoms correctly from screening until 30 days after study drug administration: a. Intrauterine device (IUD) with an annual failure rate of < 1%; b. Female barrier method: cervical cap or diaphragm with spermicide; c. Tubal sterilization; d. Vasectomy or vasectomy of the male partner. 6. Subjects have to agree to use one of these contraceptive methods with their sexual partner from screening until 30 days after the end of study drug administration. 7. Male subjects have to agree not to donate sperm from screening until 30 days after administration of the study drug. 8. Subjects are able to comply with the visit schedule and fill out the diary cards correctly after trainings.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded from the study: 1. Subjects requiring inpatient treatment with influenza virus(meet any one of the following criteria): (1) Severe cases with one of the following conditions: a. Persistent high fever for > 3 days accompanied by severe cough, sputum purulence, bloody sputum, or chest pain; b. Rapid respiratory rate, dyspnea, cyanosis of lips; c. Mental changes: slow reaction, lethargy, restlessness, convulsion, etc. d. Severe vomiting, diarrhea, and dehydration; e. Concurrent pneumonia; f. Significant exacerbation of underlying diseases; g. Other clinical conditions requiring hospitalization. (2) Critical cases with one of the following conditions: a. Respiratory failure; b. Acute necrotizing encephalopathy; c. Septic shock; d. Multiple organ dysfunction; e. Other serious clinical conditions requiring monitoring and treatment. 2. Severe cases at high risk (meet any one of the following criteria): (1) Severe or uncontrolled underlying medical conditions: blood diseases, chronic respiratory diseases (e.g. chronic obstructive pulmonary disease, bronchial asthma), hepatic insufficiency (ALT or AST >= 3 ULN, total bilirubin >= 5 ULN), renal insufficiency (serum creatinine > 177 umol/L or 2 mg/dL), cardiovascular diseases (such as congenital heart disease, coronary heart disease, chronic congestive heart failure, electrocardiogram showed QTc prolongation (QTcF > 450ms in men and QTcF > 470ms in women), etc. Except hypertension without any cardiovascular-related symptoms), nervous system and neuromuscular diseases, metabolic and endocrine diseases, psychiatric patients; (2) Immunodeficiency, such as malignant tumors, organ or bone marrow transplantation, HIV infection, or immunosuppressant therapy in the past 3 months; (3) Other diseases requiring treatment with aspirin or salicylate; (4) Obese people [body mass index (BMI) > 30·0]. 3. Bronchitis, pneumonia, pleural effusion, or interstitial lesions were suspected by clinicians or confirmed by chest imaging. 4. Subjects with acute respiratory infection, tympanitis or nasosinusitis within 2 weeks before screening. 5. Subjects with concurrent infection requiring systemic antimicrobial therapy or white blood cell count > 10·0 × 109/L at screening. 6. Subjects with cough purulent sputum or suppurative tonsillitis. 7. Subjects with dysphagia or any gastrointestinal disease affecting drug absorption (including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, subtotal gastrectomy, etc.). 8. Subjects with suspected allergic to the active ingredients or excipients of the study drugs, or to acetaminophen. 9. Body weight < 40·0 kg. 10. SARS-CoV-2 rapid antigen or nucleic acid test positive during the screening. 11. Subjects who have received anti-influenza drugs (neuraminidase inhibitors, hemagglutinin inhibitors, and M2 channel blockers, such as: oseltamivir, zanamivir, peramivir, laninamivir, umifenovir, favipiravir, baloxavir marboxil, rimantadine, amantadine, arbidol, or nitazoxanide) within 7 days before screening or influenza vaccination within 6 months before screening. 12. Subjects who have received the study drug or device for any indication within 30 days before screening. 13. Subjects who are deemed unsuitable for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time to alleviation of influenza-related symptoms (h); | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportions of patients with influenza virus RNA positive and detectable virus titers at each follow-up visit (%);Changes in virus titers (log10 [TCID50/mL]) and virus RNA (log10 [Copies/mL]) from baseline to each follow-up;The time to a return to influenza virus negative (h);The proportion of patients achieving alleviation of all influenza-related symptoms at each follow-up (%);Changes in Influenza Symptom Severity Scale from baseline to each follow-up;The time to alleviation of four systematic symptoms (headache, feverishness or chills, muscle or joint pain, and fatigue) (h);The time to alleviation of three respiratory symptoms (cough, sore throat, and nasal congestion) (h);The time to alleviation of each individual influenza-related symptoms (h);Recovery of body temperature at each follow-up (°C );The time to alleviation of feverishness (h);Body temperature at each follow-up (°C );The time to a return to pre-infection health status (h);Changes in EQ VAS scores from baseline to each follow-up;Incidence of influenza-related complications (inpatient treatment, death, nasosinusitis, bronchitis, tympanitis, radiological confirmed pneumonia) (%);The proportion (%) and frequency of patients requiring rescue drugs; | — |
Countries
China
Contacts
Public ContactNanshan ZHONG
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
Outcome results
None listed