Status:
COMPLETED
A Study of ZSP1273 Tablets in Patients With Acute Uncomplicated Influenza A
Lead Sponsor:
Guangdong Raynovent Biotech Co., Ltd
Conditions:
Influenza A
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief Summary
This is a multi-center, randomized, double-blind, placebo-controlled, and active controlled clinical trial to assess the efficacy and safety of ZSP1273 tablets in the treatment of Acute Uncomplicated ...
Eligibility Criteria
Inclusion
- Patients who are able to understand the study and comply with all study procedures, and willing to provide written informed consent/assent prior to the predose examinations appropriately.
- Male or female patient s aged ≥ 18 to ≤ 64 years at the time of signing the informed consent/assent form
- Patients with a diagnosis of influenza virus infection confirmed by all of the following
- Positive Rapid Antigen Test (RAT) with throat swabs;and
- Fever ≥ 38ºC (axillary) in the predose examinations or \> 4 hours after dosing of antipyretics if they were taken;and
- At least one of the following general systemic symptoms associated with influenza are present with a severity of moderate or greater I. Headache II. Feverishness or chills III. Muscle or joint pain IV. Fatigue
- At least one of the following respiratory symptoms associated with influenza are present with a severity of moderate or greater I. Cough II. Sore throat III. Nasal congestion
- The time interval between the onset of symptoms and the predose examinations is 48 hours or less. The onset of symptoms is defined as either
- Time of the first increase in body temperature (an increase of at least 1ºC from normal body temperature)
- Time when the patient experiences at least one general or respiratory symptom
- Women of childbearing potential (WOCBP) who agree to use a highly effective method of contraception for 3 months after the first dose of ZSP1273 or oseltamivir
Exclusion
- Patients with severe influenza virus infection requiring inpatient treatment
- Patients aged ≥ 18 years with known allergy to oseltamivir (Tamiflu) or ZSP1273
- Patients unable to swallow tablets or capsules or any medical history in gastrointestinal that interferes with the absorption of drugs
- Patients who have received antiviral medication including peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir, or amantadine within 7 days prior to the predose examinations
- Patients who have received Chinese patent medicine or herbal medicine with antiviral effect within 7 days prior to the predose examinations
- Patients who have received Anti-influenzal prescription within 7 days prior to the predose examinations
- Subject who produces purulent sputum or has suppurative tonsillitis.
- White blood cells(WBC)\>10.0×109/L at screening.
- Chest X - ray examination confirmed bronchitis,pneumonia,pleural effusion or pulmonary interstitial lesions.
- Patients who have experienced respiratory tract infection,Otitis media,nasosinusitis.
- Patients with severe or uncontrollable underlying diseases:blood disorders,severe chronic obstructive pulmonary disease(COPD),liver disorders(ALT or AST≥3 ULN,total bilirubin≥1.5 ULN),kidney disorders(serum creatinine\>177μmol/L or 2mg/dL),chronic congestive heart failure(NYHA III-IV),mental disorders
- Immunodeficiency,including malignant tumor,organ or marrow transplant,human immunodeficiency virus \[HIV\] infection,or patients receiving immunosuppressant therapy 3 months prior to enrollment.
- Concomitant therapy with aspirin or salicylic acid.
- Patients weighing \< 40 kg or morbid obesity(Body mass index \[BMI\]≥30kg/m2)
- Known history of alcohol abuse or drug abuse
- Pregnancy or breastfeeding at screening and during the study.All female subjects of childbearing potential must have a negative urine pregnancy test at screening and during the trial.
- Have received any other investigational products within 3 months prior to dosing.
- Patients who, in the opinion of the investigator, would be unlikely to comply with required study visits, self-assessments, and interventions
Key Trial Info
Start Date :
December 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2023
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT04683406
Start Date
December 28 2020
End Date
May 16 2023
Last Update
June 27 2023
Active Locations (76)
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1
The First Affiliated Hospital of bengbu medical college
Bengbu, Anhui, China
2
Xuancheng People's Hospital
Xuancheng, Anhui, China
3
Beijing Chaoyang Hospital,Capital Medical University
Beijing, Beijing Municipality, China
4
Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, China