Clinical trial NCT05702489: A Study to Evaluate the Efficacy and Safety of ZX-7101A Tablets in Adults with Uncomplicated Influenza
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study to Evaluate the Efficacy and Safety of ZX-7101A Tablets in Adults with Uncomplicated Influenza
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Influenza, Human
Lead sponsor: Nanjing Zenshine Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-01-27
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare ZX-7101A in Chinese Adults patients with uncomplicated influenza. The main questions it aims to answer are:

* The efficacy of ZX-7101A in Chinese Adults patients with uncomplicated influenza.
* The safety of ZX-7101A in Chinese Adults patients with uncomplicated influenza.


Eligibility criteria: Inclusion Criteria:

* ≥18 to ≤64 years of age at the time of signing the ICF.
* Patients in the screening period met the following criteria: (1) rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) test positive; (2) fever ≥ 37.3℃ (axillary temperature) at screening; if taking antipyretics, axillary temperature ≥ 37.3℃ after taking the drug (more than 4 hours). (3) At least one of flu-related systemic symptoms is moderate or greater in severity: a. muscle or joint pain, b. fatigue, c. headache, d. fever. (4) At least one of the influenza-related respiratory symptoms is moderate or greater in severity: a. nasal congestion, b. sore throat, c. cough.
* The first occurrence of influenza symptoms ≤ 48 hours from the time of patient randomization.

Exclusion Criteria:

* Patients with influenza virus infection requiring hospitalization.
* High-risk population.
* Bronchitis, pneumonia, pleural effusion or interstitial disease suspected by a clinician or confirmed by chest imaging \[X-ray (anteroposterior or anteroposterior)/CT\] and judged clinically significant by the investigator at screening.
* Patients who have developed acute respiratory tract infection, otitis media, and sinusitis within 2 weeks before screening.
* Patients with other infections requiring systemic anti-infective treatment, or blood routine examination at screening: white blood cell count (WBC) \> 10.0 × 109/L.
* Patients with purulent sputum or suppurative tonsillitis.
* Those who have difficulty in swallowing drugs or have a history of gastrointestinal diseases that seriously affect drug absorption.
* Medications against influenza virus within 7 days prior to Screening.

Primary outcomes:
measure: The time to the remission of all influenza symptoms (hours)
timeFrame: from accepting ZX-7101A until the 15 days after the first dosing
Secondary outcomes:
measure: Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
timeFrame: from accepting ZX-7101A until the 15 days after the first dosing
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
Study officials:
affiliation: Huashan Hospital
name: hong wen Zhang, doctor
role: PRINCIPAL_INVESTIGATOR
References: