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NCT05702489
A Study to Evaluate the Efficacy and Safety of ZX-7101A Tablets in Adults With Uncomplicated Influenza
Conditions: Influenza, Human
Sex: All
Ages: 18 Years – 64 Years
Phase: PHASE2, PHASE3
Enrollment: 210
Sponsor: Nanjing Zenshine Pharmaceuticals
Location: China
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.
Source: ClinicalTrials.gov (NCT05702489). StuddyBuddy aggregates publicly available trial information.