The primary object of this study is evaluating the efficacy of ZX-7101A tablets versus placebo in the treatment of uncomplicated simple influenza in adolescents. The seongdary object is evaluating the safety of ZX-7101A tablet in the treatment of uncomplicated simple influenza in adolescents.
In this study, adolescents aged 12 and \< 18 with uncomplicated influenza are selected as subjects. Typical systemic and/or respiratory influenza symptoms were required, and the time interval between the first onset of influenza symptoms and random enrollment was less than 48 hours. This study is divided into screening/treatment period (D1) and observation period (about 2 weeks). You will be eligible before starting study therapy on day 1 (D1). Participants were randomly assigned 1:1 to ZX-7101A group (dose 40 mg, administration once) or placebo group (dose 1 placebo tablet, administration once), with 180 participants planned to be included in each group, for a total of about 360 participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
361
Fudan University affiliated Huashan Hospital
Shanghai, Shanghai Municipality, China
The time to the remission of all influenza symptoms (hours)
Defined as the time from the start of study treatment to the time all flu symptoms are relieved. Symptom relief was defined as all seven influenza symptoms assessed by the subject on the subject diary card(Stuffy nose, sore throat, cough, muscle or joint pain, fatigue, headache, fever or chills/sweating) were 0 (asymptomatic) or 1 (mild),nd the duration is at least 21.5 hours (approximately 24 hours -10%)
Time frame: From accepting ZX-7101A until the 15 days after the first dosing
The time influenza RNA turns negative
Defined as the time from initiation of treatment until the first influenza viral RNA falls below the lower limit of quantification (measured by RT-PCR)
Time frame: From accepting ZX-7101A until the 15 days after the first dosing
The time Virus Titer turns negative
Defined as the time from initiation of treatment until the first viral titer falls below the lower limit of quantification
Time frame: From accepting ZX-7101A until the 15 days after the first dosing
Percentage of subjects with RT-PCR positive influenza virus RNA and measurable virus titer at each visit (unit: %)
the number of subjects with RT-PCR positive influenza virus RNA and measurable virus titer /The number of subjects
Time frame: From accepting ZX-7101A until the 15 days after the first dosing
Time (in hours) for relief of 4 systemic symptoms (muscle or joint pain, weakness, headache, fever, or chills/sweating)
Symptom remission is defined as a score of 0 (asymptomatic) or 1 (mild) for all four of the above symptoms. The duration is at least 21.5 hours (About 24 hours -10%)
Time frame: From accepting ZX-7101A until the 15 days after the first dosing
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