Status:
COMPLETED
To Evaluate the Efficacy and Safety of TG-1000 Compared With Placebo in Adult Patients With Acute Uncomplicated Influenza Virus Infection
Lead Sponsor:
TaiGen Biotechnology Co., Ltd.
Collaborating Sponsors:
R&G Pharma Studies Co.,Ltd.
Conditions:
Influenza Virus Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 uncomplic...
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent.
- Age ≥ 18 (or legal adult age) to \< 65 years at the time of signing the informed consent.
- Must have a positive result of Rapid influenza diagnostic test (RIDT) or Polymerase chain reaction (PCR).
- The time interval between the onset of symptoms and the randomization is 48 hours or less.
- Must be able to comply with all study procedures and assessments, including completion of the patient diary.
Exclusion
- Patients with severe influenza virus infection requiring inpatient treatment.
- Patients with high risk factors may develop into severe cases.
- Investigator suspects or confirms that patients with bronchitis, pneumonia, pleural effusion or interstitial disease through chest imaging examination.
- Acute respiratory infection, otitis media or sinusitis within 2 weeks prior to Screening.
- Purulent sputum or purulent tonsillitis.
- Positive nucleic acid test for COVID-19.
- Suspects allergic to active ingredients or excipients.
- Body weight \< 40 kg.
- Has received anti-influenza drug.
- Has received any investigational agents or devices for any indication within 30 days prior to Screening.
- Patients who, in the opinion of the Investigator, may not be qualified or suitable for the study.
Key Trial Info
Start Date :
December 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2022
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT04706468
Start Date
December 15 2020
End Date
February 15 2022
Last Update
March 9 2022
Active Locations (1)
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1
Xiangya Hospital Central South University
Hunan, China