To Evaluate the Efficacy and Safety of TG-1000 Compared With Placebo in Adult Patients With Acute Uncomplicated Influenza Virus Infection

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

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

Study Overview

• Status: Completed
• Conditions: Influenza Virus Infection
• Intervention / Treatment: Drug: TG-1000

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".

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hunan, China
    • Xiangya Hospital Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 40 mg TG-1000; Participants received 40 mg of TG-1000 and 40 mg of placebo orally on Day 1 and 40 mg of placebo on Day 3.	Drug: TG-1000; Capsules taken orally
EXPERIMENTAL: 80 mg TG-1000; Participants received 80 mg of TG-1000 orally on Day 1 and 40 mg of placebo on Day 3.	Drug: TG-1000; Capsules taken orally
EXPERIMENTAL: 40 mg TG-1000+40 mg TG-1000; Participants received 40 mg of TG-1000 and 40 mg of placebo orally on Day 1 and 40 mg of TG-1000 on Day 3.	Drug: TG-1000; Capsules taken orally
PLACEBO_COMPARATOR: Placebo; Participants received 80 mg of placebo orally on Day 1 and 40 mg of placebo on Day 3.	Drug: TG-1000; Capsules taken orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The antiviral effect of TG-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection.	The time between the initiation of the study treatment and the first time when the influenza virus RNA cannot be detected.	Up to Day 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to alleviation of all influenza symptoms.	The time between the initiation of the study treatment and the alleviation of influenza symptoms.	Up to Day 9
The percentage of patients have positive for virus RNA by real time polymerase chain reaction(RT-PCR).	The percentage of patients positive for virus RNA by RT-PCR.	Up to Day 9
The change from baseline in virus RNA by RT-PCR (unit: log₁₀ virus particles/mL).	The change from baseline in the amount of virus RNA.	Up to Day 9
Area Under the Concentration (AUC) of virus RNA by RT-PCR and AUC of virus titer.	AUC of the viral load by RT-PCR and AUC of viral titer measured from baseline to Day 9±2 or early termination (Visit 5).	Up to Day 9
The percentage of patients whose symptoms have been alleviated at each time point.	The percentage of patients whose symptoms are alleviated at each time point.	Up to Day 9
The percentage of patients reporting normal temperature at each time point.	The percentage of patients whose axillary temperature drops to less than 37ºC after the initiation of the study treatment in the analysis population.	Up to Day 9
Time to resolution of fever.	The time between the initiation of the study treatment and the resolution of fever.	Up to Day 9
Body temperature at each time point.	Measured axillary temperature.	Up to Day 9
Time to return to preinfluenza health status.	Patients will be asked to record their pre-influenza health status between 0 (worst possible health) and 10 (normal health).	Up to Day 9
The visual analog scale (VAS) score change from baseline of quality of life (QOL) questionnaire.	The VAS score change from baseline of QOL questionnaire.The QOL questionnaire consists 2 sections: the descriptive system and the VAS. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is divided into 5 levels. The VAS records the patient's self-rated health on a 20-cm vertical visual analogue with "the best health the patient can imagine" as 100 and "the worst health the patient can imagine" as 0.	Up to Day 9
Incidence of influenza-related complications (hospitalization, death, sinusitis, bronchitis, otitis media, and radiologically confirmed pneumonia).	The percentage of patients in the analysis population who experience each influenza-related complication (hospitalization, death, sinusitis, otitis media, bronchitis, and radiologically confirmed pneumonia) as an AE after the initiation of the study treatment.	Up to Day 9
The percentage of patients taking acetaminophen.	The percentage of patients who took acetaminophen.	Up to Day 9

Collaborators and Investigators

• Sponsor: TaiGen Biotechnology Co., Ltd.
• Collaborators: R&G Pharma Studies Co.,Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 15, 2020
• Primary Completion (ACTUAL): February 15, 2022
• Study Completion (ACTUAL): February 15, 2022

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 10, 2021
• First Posted (ACTUAL): January 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Orthomyxoviridae Infections; Infections; Communicable Diseases; Virus Diseases; Influenza, Human
• Other Study ID Numbers: TG-1000-C-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No