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
1 other identifier
interventional
750
1 country
76
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 influenza A.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2020
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2020
CompletedFirst Posted
Study publicly available on registry
December 24, 2020
CompletedStudy Start
First participant enrolled
December 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2023
CompletedJune 27, 2023
June 1, 2023
2.3 years
December 13, 2020
June 24, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Time to Alleviation of Symptoms in Participants Randomized to ZSP1273 or Placebo
Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms). Time to alleviation of symptoms was defined as the time from the start of the study treatment to the time when all seven influenza-related symptoms were assessed by the participant as absent (0) or mild (1) for at least 21.5 hours. Time to alleviation of symptoms was analyzed using the Kaplan-Meier(KM) method; participants who did not experience alleviation of symptoms were censored at the last observation time point
Up to 14 days after first dose
Time to Alleviation of Symptoms in Participants Randomized to ZSP1273 or Oseltamivir
Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms). Time to alleviation of symptoms was defined as the time from the start of the study treatment to the time when all seven influenza-related symptoms were assessed by the participant as absent (0) or mild (1) for at least 21.5 hours. Time to alleviation of symptoms was analyzed using the Kaplan-Meier(KM) method; participants who did not experience alleviation of symptoms were censored at the last observation time point
Up to 14 days after first dose
Secondary Outcomes (33)
Percentage of Participants With Positive Influenza Virus Titer at Each Time Point in Participants Randomized to ZSP1273 or Placebo
Days 2, 4, 6
Percentage of Participants With Positive Influenza Virus Titer at Each Time Point in Participants Randomized to ZSP1273 or Oseltamivir
Days 2, 4, 6
Percentage of Participants With Positive Influenza Virus by RT-PCR at Each Time Point in Participants Randomized to ZSP1273 or Placebo
Days 2, 4, 6
Percentage of Participants With Positive Influenza Virus by RT-PCR at Each Time Point in Participants Randomized to ZSP1273 or Oseltamivir
Days 2, 4, 6
Change From Baseline in Virus Titer at Each Time Point in Participants Randomized to ZSP1273 or Placebo
Days 2, 4, 6
- +28 more secondary outcomes
Study Arms (3)
ZSP1273 600 mg + Oseltamivir Placebo BID
EXPERIMENTALSubjects received 5 doses of ZSP1273 at 600 mg once a day along with matching placebo of oseltamivir placebo orally twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5 days
Oseltamivir 75mg + ZSP1273 Placebo
ACTIVE COMPARATORSubjects received 10 doses of Oseltamivir at a dose of 75 mg twice daily (BID) with matching placebo of ZSP1273 orally once a day with approximately 12 hour (+/- 2) intervals, over 5 days
Placebo Comparator
PLACEBO COMPARATORSubjects received 5 doses of matching placebo of ZSP1273 and Oseltamivir twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5 days
Interventions
Placebo capsules matching oseltamivir2 X 75-mg
Placebo capsules matching ZSP1273 600 mg
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Xiamen Zhongshan Hospital
Xiamen, Fujian, China
Dongguan People's Hospital
Dongguan, Guangdong, China
Foshan First People's Hospital
Foshan, Guangdong, China
Shunde University of Southern Medical University
Foshan, Guangdong, China
Guangdong Province Traditional Chinese Medical Hospital
Guangzhou, Guangdong, China
Nanfang Hospital
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, China
Huizhou Central People's Hospital
Huizhou, Guangdong, China
Jieyang People's Hospital
Jieyang, Guangdong, China
Qingyuan People's Hospital
Qingyuan, Guangdong, China
Shantou Central Hospital
Shantou, Guangdong, China
Yuebei People's Hospital
Shaoguan, Guangdong, China
Shenzhen Luohu Hospital Group Luohu People's Hospital
Shenzhen, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Songgang People's Hospital
Shenzhen, Guangdong, China
Nanning First People's Hospital
Nanning, Guangxi, China
Guizhou Provicial People's Hospital
Guiyang, Guizhou, China
Affiliated Hospital Zunyi Medical College
Zunyi, Guizhou, China
First Hospital of Qinhuangdao
Qinhuangdao, Hebei, China
Huaihe Hospital of Henan University
Huaihe, Henan, China
Luoyang Central Hospital Affiliated To Zhengzhou University
Luoyang, Henan, China
Nanyang Central Hospital
Nanyang, Henan, China
Nanyang First People's Hospital
Nanyang, Henan, China
The Second People's hospital of Nanyang
Nanyang, Henan, China
The Third Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, China
The Third Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Henan Provicial People's Hospital
Zhengzhou, Henan, China
Zhengzhou Central Hospital
Zhengzhou, Henan, China
Zhengzhou Sixth Hospital
Zhengzhou, Henan, China
Yiyang Central hospital
Yiyang, Hunan, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Nanjing Jiangning Hospital
Nanjing, Jiangsu, China
Sir run run Hospital Nanjing Medical University
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
Jiujiang University Affiliated Hospital
Jiujiang, Jiangxi, China
First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
The Third Hospital Of Nanchang
Nanchang, Jiangxi, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
Shangyao People's Hospital
Shangyao, Jiangxi, China
The First Hospital Of Jilin University
Changchun, Jilin, China
General Hospital of Liaohe Oilfield
Panjin, Liaoning, China
Shenyang Central Hospital Affiliated To Shenyang medical college
Shenyang, Liaoning, China
Binzhou Medical University Hospital
Binzhou, Shandong, China
Heze Municipal Hospital
Heze, Shandong, China
Jinan Central Hospital
Jinan, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Linyi People's Hospital
Linyi, Shandong, China
Shandong Energy Zaozhuang Mining
Zaozhuang, Shandong, China
PKUCare luzhong Hospital
Zibo, Shandong, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Chengdu Xinhua Hospital
Chengdu, Sichuan, China
General Hospital of Western Theater of PLA
Chengdu, Sichuan, China
Sichuan Provicial People's Hospital
Chengdu, Sichuan, China
The Third People's Hospital of Wuhou, Chengdu
Chengdu, Sichuan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Dazhou Central Hospital
Dazhou, Sichuan, China
Affiliated Hospital of North Sichuan College
Nanchong, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The first People hospital of Yunnan Province
Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Ruian People's Hospital
Ruian, Zhejiang, China
Related Publications (1)
Yang Z, Zhan Y, Li Z, Lin Z, Fang Z, Li H, Chen X, Ding B, Zeng H, Zhang X, Song Y, Lin Z, Liang S, Luo J, Huang J, Chen X, Zhong N; Onradivir Trial Recruitment and Medical Monitoring Group. Efficacy and safety of onradivir in adults with acute uncomplicated influenza A infection in China: a multicentre, double-blind, randomised, placebo-controlled and oseltamivir-controlled, phase 3 trial. Lancet Respir Med. 2025 Jul;13(7):597-610. doi: 10.1016/S2213-2600(25)00046-3. Epub 2025 Jun 7.
PMID: 40489986DERIVED
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2020
First Posted
December 24, 2020
Study Start
December 28, 2020
Primary Completion
April 1, 2023
Study Completion
May 16, 2023
Last Updated
June 27, 2023
Record last verified: 2023-06