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

Influenza Virus Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04706468
• Other study ID #: TG-1000-C-02
• Status: Completed
• Phase: Phase 2
• Start date: December 15, 2020
• Est. completion date: February 15, 2022

Study information

• Verified date: March 2022
• Source: TaiGen Biotechnology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: February 15, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Influenza Virus Infection
• Influenza, Human
• Virus Diseases

Intervention

Drug:
• TG-1000
Capsules taken orally

Locations

Country	Name	City	State
China	Xiangya Hospital Central South University	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
TaiGen Biotechnology Co., Ltd.	R&G Pharma Studies Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time to resolution of fever.	The time between the initiation of the study treatment and the resolution of fever.	Up to Day 9
Secondary	Body temperature at each time point.	Measured axillary temperature.	Up to Day 9
Secondary	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
Secondary	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
Secondary	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
Secondary	The percentage of patients taking acetaminophen.	The percentage of patients who took acetaminophen.	Up to Day 9