Clinical trial NCT04706468: To Evaluate the Efficacy and Safety of TG-1000 Compared With Placebo in Adult Patients With Acute Uncomplicated Influenza Virus Infection
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Dose-ranging Study to Evaluate the Efficacy and Safety of TG-1000 Compared With Placebo in Adult Patients With Acute Uncomplicated Influenza Virus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza Virus Infection
Lead sponsor: TaiGen Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: R&G Pharma Studies Co.,Ltd.
First posted: 2021-01-12
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Phase 2, Multicenter, Randomized, Double-blind, Dose-ranging
Primary purpose: TREATMENT

Brief summary: To evaluate the antiviral effect of TG-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection.

Detailed description: This study is a multicenter, randomized, double-blind, dose-ranging study to evaluate the efficacy and safety of different doses of TG-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection.

Approximately 200 patients will be randomly assigned to 1 of 4 treatments groups in a ratio of 1:1:1:1 to receive study treatment orally: "40 mg TG-1000", "80 mg TG-1000", "40mg+40mg TG-1000" or "placebo".

Eligibility criteria: Inclusion Criteria:

1. Willing and able to provide written informed consent.
2. Age ≥ 18 (or legal adult age) to \< 65 years at the time of signing the informed consent.
3. Must have a positive result of Rapid influenza diagnostic test (RIDT) or Polymerase chain reaction (PCR).
4. The time interval between the onset of symptoms and the randomization is 48 hours or less.
5. Must be able to comply with all study procedures and assessments, including completion of the patient diary.

Exclusion Criteria:

1. Patients with severe influenza virus infection requiring inpatient treatment.
2. Patients with high risk factors may develop into severe cases.
3. Investigator suspects or confirms that patients with bronchitis, pneumonia, pleural effusion or interstitial disease through chest imaging examination.
4. Acute respiratory infection, otitis media or sinusitis within 2 weeks prior to Screening.
5. Purulent sputum or purulent tonsillitis.
6. Positive nucleic acid test for COVID-19.
7. Suspects allergic to active ingredients or excipients.
8. Body weight \< 40 kg.
9. Has received anti-influenza drug.
10. Has received any investigational agents or devices for any indication within 30 days prior to Screening.
11. Patients who, in the opinion of the Investigator, may not be qualified or suitable for the study.

Primary outcomes:
measure: The antiviral effect of TG-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection.
timeFrame: Up to Day 9
Secondary outcomes:
measure: Time to alleviation of all influenza symptoms.
timeFrame: Up to Day 9
measure: The percentage of patients have positive for virus RNA by real time polymerase chain reaction(RT-PCR).
timeFrame: Up to Day 9
measure: The change from baseline in virus RNA by RT-PCR (unit: log₁₀ virus particles/mL).
timeFrame: Up to Day 9
measure: Area Under the Concentration (AUC) of virus RNA by RT-PCR and AUC of virus titer.
timeFrame: Up to Day 9
measure: The percentage of patients whose symptoms have been alleviated at each time point.
timeFrame: Up to Day 9
measure: The percentage of patients reporting normal temperature at each time point.
timeFrame: Up to Day 9
measure: Time to resolution of fever.
timeFrame: Up to Day 9
measure: Body temperature at each time point.
timeFrame: Up to Day 9
measure: Time to return to preinfluenza health status.
timeFrame: Up to Day 9
measure: The visual analog scale (VAS) score change from baseline of quality of life (QOL) questionnaire.
timeFrame: Up to Day 9
measure: Incidence of influenza-related complications (hospitalization, death, sinusitis, bronchitis, otitis media, and radiologically confirmed pneumonia).
timeFrame: Up to Day 9
measure: The percentage of patients taking acetaminophen.
timeFrame: Up to Day 9
Other outcomes:
Locations:
city: Hunan
country: China
facility: Xiangya Hospital Central South University
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Yan Huang
role: PRINCIPAL_INVESTIGATOR
References: