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A Study of ZSP1273 Tablets in Patients With Acute Uncomplicated Influenza A | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study of ZSP1273 Tablets in Patients With Acute Uncomplicated Influenza A

A Randomized, Double-blind Phase III Clinical Study of ZSP1273 Tablets Compared With Placebo or Oseltamivir Patients With Acute Uncomplicated Influenza A

NCT04683406•Guangdong Raynovent Biotech Co., Ltd

View on ClinicalTrials.gov

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 influenza A.

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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.
•2. Male or female patient s aged ≥ 18 to ≤ 64 years at the time of signing the informed consent/assent form
•3. 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
•4. 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
+1 more criteria

Exclusion Criteria

•1. Patients with severe influenza virus infection requiring inpatient treatment
•2. Patients aged ≥ 18 years with known allergy to oseltamivir (Tamiflu) or ZSP1273
•3. Patients unable to swallow tablets or capsules or any medical history in gastrointestinal that interferes with the absorption of drugs
•4. Patients who have received antiviral medication including peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir, or amantadine within 7 days prior to the predose examinations
•5. Patients who have received Chinese patent medicine or herbal medicine with antiviral effect within 7 days prior to the predose examinations
•6. Patients who have received Anti-influenzal prescription within 7 days prior to the predose examinations
•7. Subject who produces purulent sputum or has suppurative tonsillitis.
•8. White blood cells(WBC)\>10.0×109/L at screening.
•9. Chest X - ray examination confirmed bronchitis,pneumonia,pleural effusion or pulmonary interstitial lesions.
•10. Patients who have experienced respiratory tract infection,Otitis media,nasosinusitis.
+8 more criteria

Locations (76)

The First Affiliated Hospital of bengbu medical college

Bengbu, Anhui, China

Xuancheng People's Hospital

Xuancheng, Anhui, China

Beijing Chaoyang Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Beijing Ditan Hospital Capital Medical University

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

People's Hospital of Cuanjiang, Chongqing

Chongqing, Chongqing Municipality, China

Third Military Medical University

Chongqing, Chongqing Municipality, China

Quanzhou First Hospital

Quanzhou, Fujian, China

Fujian Provincal Hospital

Xiamen, Fujian, China

Xiamen Hospital of T.C.M

Xiamen, Fujian, China

Key Dates

Start Date

December 28, 2020

Primary Completion Date

April 1, 2023

Completion Date

May 16, 2023

Last Updated

June 27, 2023

Enrollment

750

ACTUAL participants

Conditions

Influenza A

Interventions

ZSP1273 600 mg

DRUG

Placebo to Oseltamivir

DRUG

Oseltamivir(oral)

DRUG

Placebo to ZSP1273

DRUG

A Phase I/II Study on Safety AND Immunogenicity of AZD4117 and AZD5315 Vaccines (PANDA)

NCT07128615

Influenza A

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ACTIVE_NOT_RECRUITINGPHASE1

Treatment of Respiratory Complications Associated With COVID19,Influenza ,Metapneumovirus,RSV Infection Using ProTrans®

NCT04896853

COVID-19 Acute Respiratory Distress SyndromeInfluenza A+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of ZSP1273 Tablets in Patients With Acute Uncomplicated Influenza A

Inclusion Criteria

Exclusion Criteria

A Phase I/II Study on Safety AND Immunogenicity of AZD4117 and AZD5315 Vaccines (PANDA)

Treatment of Respiratory Complications Associated With COVID19,Influenza ,Metapneumovirus,RSV Infection Using ProTrans®

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