To evaluate the antiviral effect of TG-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
202
Capsules taken orally
Xiangya Hospital Central South University
Hunan, China
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.
Time frame: Up to Day 9
Time to alleviation of all influenza symptoms.
The time between the initiation of the study treatment and the alleviation of influenza symptoms.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
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Time frame: Up to Day 9
Time to resolution of fever.
The time between the initiation of the study treatment and the resolution of fever.
Time frame: Up to Day 9
Body temperature at each time point.
Measured axillary temperature.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Up to Day 9
The percentage of patients taking acetaminophen.
The percentage of patients who took acetaminophen.
Time frame: Up to Day 9