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Completed

NCT Number: NCT05702489

A Study to Evaluate the Efficacy and Safety of ZX-7101A Tablets in Adults with Uncomplicated Influenza

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Zhongshan Hospital Affiliated to Fudan University

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZX-7101A

Drug

a drug to treatment influenza in Chinese adults

Primary outcomes

  1. The time to the remission of all influenza symptoms (hours)

    Time frame: from accepting ZX-7101A until the 15 days after the first dosing

    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);

Secondary outcomes

  1. Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0

    Time frame: from accepting ZX-7101A until the 15 days after the first dosing

    The Number of Participants with Treatment-Related Adverse Event will be evalated as the change of vital signs, electrocardiogram (P Wave, QRS Complex, QT Interval), physical examination, and Laboratory test compared with the baseline.

Sponsors and collaborators

Lead sponsor

Nanjing Zenshine Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 27, 2023
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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