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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-15

Study Completion Date

2022-02-15

Brief Summary

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

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Detailed Description

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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".

Conditions

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Influenza Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A Phase 2, Multicenter, Randomized, Double-blind, Dose-ranging

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Quadruple

Study Groups

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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.

Group Type EXPERIMENTAL

TG-1000

Intervention Type DRUG

Capsules taken orally

80 mg TG-1000

Participants received 80 mg of TG-1000 orally on Day 1 and 40 mg of placebo on Day 3.

Group Type EXPERIMENTAL

TG-1000

Intervention Type DRUG

Capsules taken orally

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.

Group Type EXPERIMENTAL

TG-1000

Intervention Type DRUG

Capsules taken orally

Placebo

Participants received 80 mg of placebo orally on Day 1 and 40 mg of placebo on Day 3.

Group Type PLACEBO_COMPARATOR

TG-1000

Intervention Type DRUG

Capsules taken orally

Interventions

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TG-1000

Capsules taken orally

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No