NCT04706468

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2020

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

January 6, 2021

Last Update Submit

March 8, 2022

Conditions

Influenza Virus Infection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Time to alleviation of all influenza symptoms.

    Up to Day 9

  • The percentage of patients have positive for virus RNA by real time polymerase chain reaction(RT-PCR).

    Up to Day 9

  • The change from baseline in virus RNA by RT-PCR (unit: log₁₀ virus particles/mL).

    Up to Day 9

  • Area Under the Concentration (AUC) of virus RNA by RT-PCR and AUC of virus titer.

    Up to Day 9

  • The percentage of patients whose symptoms have been alleviated at each time point.

    Up to Day 9

  • +7 more secondary outcomes

Study Arms (4)

40 mg TG-1000

EXPERIMENTAL

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

80 mg TG-1000

EXPERIMENTAL

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

Drug: TG-1000

40 mg TG-1000+40 mg TG-1000

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: TG-1000

Interventions

TG-1000DRUG

Capsules taken orally

40 mg TG-100040 mg TG-1000+40 mg TG-100080 mg TG-1000Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Hospital Central South University

Hunan, China

Location

Study Officials

  • Yan Huang

    Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Quadruple
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A Phase 2, Multicenter, Randomized, Double-blind, Dose-ranging
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2021

First Posted

January 12, 2021

Study Start

December 15, 2020

Primary Completion

February 15, 2022

Study Completion

February 15, 2022

Last Updated

March 9, 2022

Record last verified: 2022-03

Locations

CN(1)