Influenza APhase 3NCT04683406
A Study of ZSP1273 Tablets in Patients With Acute Uncomplicated Influenza A
A Phase 3 study testing ZSP1273 600 mg and Oseltamivir(oral) in people with Influenza A, run by Guangdong Raynovent Biotech Co., Ltd at 76 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Influenza A
- What is being tested?
- ZSP1273 600 mg and Oseltamivir(oral)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 750 participants
- Where
- 76 sitesChina
- Study dates
- 28 Dec 2020to 16 May 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
76 sites in 1 country.
76 sites in 1 country
China76 sites
Beijing Chaoyang Hospital,Capital Medical University
Beijing, Beijing Municipality
Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality
Peking University Third Hospital
Beijing, Beijing Municipality
The First Affiliated Hospital of bengbu medical college
Bengbu, Anhui
Binzhou Medical University Hospital
Binzhou, Shandong
The First Hospital Of Jilin University
Changchun, Jilin
Chengdu Xinhua Hospital
Chengdu, Sichuan
General Hospital of Western Theater of PLA
Chengdu, Sichuan
Sichuan Provicial People's Hospital
Chengdu, Sichuan
The Third People's Hospital of Wuhou, Chengdu
Chengdu, Sichuan
West China Hospital of Sichuan University
Chengdu, Sichuan
People's Hospital of Cuanjiang, Chongqing
Chongqing, Chongqing Municipality
Third Military Medical University
Chongqing, Chongqing Municipality
Dazhou Central Hospital
Dazhou, Sichuan
Dongguan People's Hospital
Dongguan, Guangdong
Foshan First People's Hospital
Foshan, Guangdong
Shunde University of Southern Medical University
Foshan, Guangdong
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi
Guangdong Province Traditional Chinese Medical Hospital
Guangzhou, Guangdong
Nanfang Hospital
Guangzhou, Guangdong
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong
Guizhou Provicial People's Hospital
Guiyang, Guizhou
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Heze Municipal Hospital
Heze, Shandong
Huaihe Hospital of Henan University
Huaihecun, Henan
Huizhou Central People's Hospital
Huizhou, Guangdong
Jieyang People's Hospital
Jieyang, Guangdong
Jinan Central Hospital
Jinan, Shandong
Jiujiang University Affiliated Hospital
Jiujiang, Jiangxi
The first People hospital of Yunnan Province
Kunming, Yunnan
Liaocheng People's Hospital
Liaocheng, Shandong
Linyi People's Hospital
Linyi, Shandong
Luoyang Central Hospital Affiliated To Zhengzhou University
Luoyang, Henan
First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi
The Third Hospital Of Nanchang
Nanchang, Jiangxi
Affiliated Hospital of North Sichuan College
Nanchong, Sichuan
Nanjing First Hospital
Nanjing, Jiangsu
Nanjing Jiangning Hospital
Nanjing, Jiangsu
Sir run run Hospital Nanjing Medical University
Nanjing, Jiangsu
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Nanning First People's Hospital
Nanning, Guangxi
Nanyang Central Hospital
Nanyang, Henan
Nanyang First People's Hospital
Nanyang, Henan
The Second People's hospital of Nanyang
Nanyang, Henan
The Third Affiliated Hospital of Nanyang Medical College
Nanyang, Henan
General Hospital of Liaohe Oilfield
Panjin, Liaoning
Pingxiang People's Hospital
Pingxiang, Jiangxi
Qingyuan People's Hospital
Qingyuan, Guangdong
First Hospital of Qinhuangdao
Qinhuangdao, Hebei
Quanzhou First Hospital
Quanzhou, Fujian
Ruian People's Hospital
Ruian, Zhejiang
Shanghai East Hospital
Shanghai, Shanghai Municipality
Shangyao People's Hospital
Shangyao, Jiangxi
Shantou Central Hospital
Shantou, Guangdong
Yuebei People's Hospital
Shaoguan, Guangdong
Shenyang Central Hospital Affiliated To Shenyang medical college
Shenyang, Liaoning
Shenzhen Luohu Hospital Group Luohu People's Hospital
Shenzhen, Guangdong
Shenzhen People's Hospital
Shenzhen, Guangdong
Songgang People's Hospital
Shenzhen, Guangdong
Shanxi Bethune Hospital
Taiyuan, Shanxi
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Fujian Provincal Hospital
Xiamen, Fujian
Xiamen Hospital of T.C.M
Xiamen, Fujian
Xiamen Zhongshan Hospital
Xiamen, Fujian
The Third Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan
Xuancheng People's Hospital
Xuancheng, Anhui
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Yiyang Central hospital
Yiyang, Hunan
Shandong Energy Zaozhuang Mining
Zaozhuang, Shandong
Henan Provicial People's Hospital
Zhengzhou, Henan
Zhengzhou Central Hospital
Zhengzhou, Henan
Zhengzhou Sixth Hospital
Zhengzhou, Henan
PKUCare luzhong Hospital
Zibo, Shandong
Affiliated Hospital Zunyi Medical College
Zunyi, Guizhou
About this study
Official title: A Randomized, Double-blind Phase III Clinical Study of ZSP1273 Tablets Compared With Placebo or Oseltamivir Patients With Acute Uncomplicated Influenza A
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.
- Conditions
- Influenza A
- Being tested
- ZSP1273 600 mg, Placebo to Oseltamivir, Oseltamivir(oral), Placebo to ZSP1273
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZSP1273 600 mgDrug
3 X 200-mg tablet taken orally
Placebo to OseltamivirDrug
Placebo capsules matching oseltamivir2 X 75-mg
Oseltamivir(oral)Drug
2 X 75-mg tablet taken orally
Placebo to ZSP1273Drug
Placebo capsules matching ZSP1273 600 mg
| Study group | Role | What they receive |
|---|---|---|
| ZSP1273 600 mg + Oseltamivir Placebo BID | Experimental | Subjects 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 Receives: Drug: ZSP1273 600 mg; Drug: Placebo to Oseltamivir |
| Oseltamivir 75mg + ZSP1273 Placebo | Active comparator | Subjects 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 Receives: Drug: Oseltamivir(oral); Drug: Placebo to ZSP1273 |
| Placebo Comparator | Placebo comparator | Subjects received 5 doses of matching placebo of ZSP1273 and Oseltamivir twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5 days Receives: Drug: Placebo to Oseltamivir; Drug: Placebo to ZSP1273 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Virus titer was quantified from nasopharyngeal swabs by tissue culture methods.
Measured: Days 2, 4, 6
Percentage of Participants With Positive Influenza Virus Titer at Each Time Point in Participants Randomized to ZSP1273 or Oseltamivir
Virus titer was quantified from nasopharyngeal swabs by tissue culture methods.
Measured: 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
Influenza virus ribonucleic acid (RNA) was quantified from nasopharyngeal swabs.
Measured: 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
Influenza virus ribonucleic acid (RNA) was quantified from nasopharyngeal swabs.
Measured: Days 2, 4, 6
Change From Baseline in Virus Titer at Each Time Point in Participants Randomized to ZSP1273 or Placebo
Virus titer was quantified from nasopharyngeal swabs.
Measured: Days 2, 4, 6
Change From Baseline in Virus Titer at Each Time Point in Participants Randomized to ZSP1273 or Oseltamivir
Virus titer was quantified from nasopharyngeal swabs.
Measured: Days 2, 4, 6
Change From Baseline in Virus RNA (RT-PCR) at Each Time Point in Participants Randomized to ZSP1273 or Placebo
Nasopharyngeal swabs were obtained for viral quantitation.
Measured: Days 2, 4, 6
Change From Baseline in Virus RNA (RT-PCR) at Each Time Point in Participants Randomized to ZSP1273 or Oseltamivir
Nasopharyngeal swabs were obtained for viral quantitation.
Measured: Days 2, 4, 6
Area Under the Curve (AUC) Adjusted by Baseline in Influenza Virus Titer in Participants Randomized to ZSP1273 or Placebo
This endpoint was defined as AUC of change from Baseline in virus titer from Day 1 to Day 5. AUC was calculated using the trapezoidal method
Measured: Up to 6 days after first dose
Area Under the Curve (AUC) Adjusted by Baseline in Influenza Virus Titer in Participants Randomized to ZSP1273 or Oseltamivir
This endpoint was defined as AUC of change from Baseline in virus titer from Day 1 to Day 5. AUC was calculated using the trapezoidal method
Measured: Up to 6 days after first dose
Time to Cessation of Viral Shedding Determined by Virus Titer in Participants Randomized to ZSP-1273 or Placebo
Measured: Up to 6 days after first dose
Time to Cessation of Viral Shedding Determined by Virus Titer in Participants Randomized to ZSP1273 or Oseltamivir
Measured: Up to 6 days after first dose
Time to Cessation of Viral Shedding Determined by Virus RNA in Participants Randomized to ZSP1273 or Placebo
Measured: Up to 6 days after first dose
Time to Cessation of Viral Shedding Determined by Virus RNA in Participants Randomized to ZSP1273 or Oseltamivir
Measured: Up to 6 days after first dose
Percentage of Participants Whose Symptoms Were Alleviated at Each Time Point 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). Alleviation of symptoms was defined as all seven influenza-related symptoms assessed by the participant as absent (0) or mild (1)
Measured: Up to 14 days after first dose
Percentage of Participants Whose Symptoms Were Alleviated at Each Time Point 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). Alleviation of symptoms was defined as all seven influenza-related symptoms assessed by the participant as absent (0) or mild (1)
Measured: Up to 14 days after first dose
Time to Alleviation of the Four Systemic 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 the 4 systemic symptoms was defined as the time between the initiation of the study treatment to the time when all 4 systemic symptoms (headache, feverishness or chills, muscle or joint pain, and fatigue) were assessed by the participant as 0 (None) or 1 (Mild) for a duration of at least 21.5 hours.
Time to alleviation of the 4 systemic symptoms was analyzed using KM methods; participants who did not experience alleviation of symptoms were censored at the last observation time point.
Measured: Up to 14 days after first dose
Time to Alleviation of the Four Systemic 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 the 4 systemic symptoms was defined as the time between the initiation of the study treatment to the time when all 4 systemic symptoms (headache, feverishness or chills, muscle or joint pain, and fatigue) were assessed by the participant as 0 (None) or 1 (Mild) for a duration of at least 21.5 hours.
Time to alleviation of the 4 systemic symptoms was analyzed using KM methods; participants who did not experience alleviation of symptoms were censored at the last observation time point.
Measured: Up to 14 days after first dose
Time to Alleviation of the Three Respiratory 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 the 3 respiratory symptoms was defined as the time from the start of study treatment to the time when all 3 respiratory symptoms (cough, sore throat and nasal congestion) were assessed by the participant as absent (0) or mild (1) for at least 21.5 hours
- Time to alleviation of the 3 respiratory symptoms was analyzed using the KM method; participants who did not experience alleviation of symptoms were censored at the last observation time point
Measured: Up to 14 days after first dose
Time to Alleviation of the Three Respiratory 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 the 3 respiratory symptoms was defined as the time from the start of study treatment to the time when all 3 respiratory symptoms (cough, sore throat and nasal congestion) were assessed by the participant as absent (0) or mild (1) for at least 21.5 hours
- Time to alleviation of the 3 respiratory symptoms was analyzed using the KM method; participants who did not experience alleviation of symptoms were censored at the last observation time point
Measured: Up to 14 days after first dose
Change From Baseline in Composite Symptom Score at Each Time Point 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)
- The composite symptom score is the total score of the 7 influenza symptoms as assessed by the participant at each time point
Measured: Up to 14 days after first dose
Change From Baseline in Composite Symptom Score at Each Time Point 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)
- The composite symptom score is the total score of the 7 influenza symptoms as assessed by the participant at each time point
Measured: Up to 14 days after first dose
Time to Resolution of Fever in Participants Randomized to ZSP1273 or Placebo
- Time to resolution of fever was defined as the time between the initiation of the study treatment and the resolution of fever. The resolution of fever was defined as the time when the participant's self-measured axillary temperature became less than 37ºC and was maintained at less than 37ºC for a duration of at least 12 hours
- Time to resolution of fever was analyzed using KM methods; participants who did not experience resolution of fever by the last observation time point were censored at that time point
Measured: Up to 14 days after first dose
Time to Resolution of Fever in Participants Randomized to ZSP1273 or Oseltamivir
- Time to resolution of fever was defined as the time between the initiation of the study treatment and the resolution of fever. The resolution of fever was defined as the time when the participant's self-measured axillary temperature became less than 37ºC and was maintained at less than 37ºC for a duration of at least 12 hours
- Time to resolution of fever was analyzed using KM methods; participants who did not experience resolution of fever by the last observation time point were censored at that time point
Measured: Up to 14 days after first dose
Percentage of Participants Reporting Normal Temperature at Each Time Point in Participants Randomized to ZSP1273 or Placebo
Defined as the percentage of patients whose axillary temperature dropped to less than 37ºC after the initiation of study treatment
Measured: Up to 14 days after first dose
Percentage of Participants Reporting Normal Temperature at Each Time Point in Participants Randomized to ZSP1273 or Oseltamivir
Defined as the percentage of patients whose axillary temperature dropped to less than 37ºC after the initiation of study treatment
Measured: Up to 14 days after first dose
Time to Alleviation of Individual 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 each symptom was defined as the time from the start of treatment to the start of the time period when the individual symptom was assessed by the participant as 0 (None) or 1 (Mild) for a duration of at least 21.5 hours.
Measured: Up to 14 days after first dose
Time to Alleviation of Individual 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 each symptom was defined as the time from the start of treatment to the start of the time period when the individual symptom was assessed by the participant as 0 (None) or 1 (Mild) for a duration of at least 21.5 hours.
Measured: Up to 14 days after first dose
Time to Return to Preinfluenza Health Status in Participants Randomized to ZSP1273 or Placebo
Measured: Up to 14 days after first dose
Time to Return to Preinfluenza Health Status in Adults Randomized to ZSP1273 or Oseltamivir
Defined as the time between the initiation of the study treatment and the return to normal activities of daily life. The return to normal activities of daily life is defined as the time when the subject assesses his/her activities as 10.Subjects with a baseline self-rated daily activity score of 10 are not included in this analysis.
Measured: Up to 14 days after first dose
Percentage of Participants With Influenza-related Complications in Participants Randomized to ZSP1273 or Placebo
Defined as the time between the initiation of the study treatment and the return to normal activities of daily life. The return to normal activities of daily life is defined as the time when the subject assesses his/her activities as 10.Subjects with a baseline self-rated daily activity score of 10 are not included in this analysis.
Measured: Up to 14 days after first dose
Percentage of Participants With Influenza-related Complications in Participants Randomized to ZSP1273 or Oseltamivir
Measured: Up to 14 days after first dose
Change in EQ-5D-5L
Defined as the change from baseline in the index value and that in EQ VAS score as calculated from the EQ-5D-5L questionnaire.
Measured: Up to 14 days after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start28 Dec 2020
- Primary completion1 Apr 2023
- Study completion16 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Raynovent Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683406
- Sponsor's protocol ID
- ZSP1273-20-06
- Status last verified
- Jun 2023
- First submitted
- 13 Dec 2020
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40489986
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Phase III Clinical Study of ZSP1273 Tablets Compared With Placebo or Oseltamivir Patients With Acute Uncomplicated Influenza A
- ClinicalTrials.gov ID
- NCT04683406
- Acronym / sponsor ID
- ZSP1273-20-06
- Conditions
- Influenza A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Guangdong Raynovent Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ZSP1273 600 mg + Oseltamivir Placebo BID | Experimental | Drug: ZSP1273 600 mg, Drug: Placebo to OseltamivirSubjects 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 comparator | Drug: Oseltamivir(oral), Drug: Placebo to ZSP1273Subjects 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 comparator | Drug: Placebo to Oseltamivir, Drug: Placebo to ZSP1273Subjects received 5 doses of matching placebo of ZSP1273 and Oseltamivir twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5 days |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
- 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
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZSP1273 600 mg3 X 200-mg tablet taken orally | Drug | ZSP1273 600 mg + Oseltamivir Placebo BID |
| Placebo to OseltamivirPlacebo capsules matching oseltamivir2 X 75-mg | Drug | Placebo Comparator, ZSP1273 600 mg + Oseltamivir Placebo BID |
| Oseltamivir(oral)2 X 75-mg tablet taken orally | Drug | Oseltamivir 75mg + ZSP1273 Placebo |
| Placebo to ZSP1273Placebo capsules matching ZSP1273 600 mg | Drug | Oseltamivir 75mg + ZSP1273 Placebo, Placebo Comparator |
Primary outcome
Time to Alleviation of Symptoms in Participants Randomized to ZSP1273 or Placebo
Time frame: Up to 14 days after first dose
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
Time to Alleviation of Symptoms in Participants Randomized to ZSP1273 or Oseltamivir
Time frame: Up to 14 days after first dose
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
33 secondary outcomes
Percentage of Participants With Positive Influenza Virus Titer at Each Time Point in Participants Randomized to ZSP1273 or Placebo
Time frame: Days 2, 4, 6
Percentage of Participants With Positive Influenza Virus Titer at Each Time Point in Participants Randomized to ZSP1273 or Oseltamivir
Time frame: 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
Time frame: 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
Time frame: Days 2, 4, 6
Change From Baseline in Virus Titer at Each Time Point in Participants Randomized to ZSP1273 or Placebo
Time frame: Days 2, 4, 6
Change From Baseline in Virus Titer at Each Time Point in Participants Randomized to ZSP1273 or Oseltamivir
Time frame: Days 2, 4, 6
Change From Baseline in Virus RNA (RT-PCR) at Each Time Point in Participants Randomized to ZSP1273 or Placebo
Time frame: Days 2, 4, 6
Change From Baseline in Virus RNA (RT-PCR) at Each Time Point in Participants Randomized to ZSP1273 or Oseltamivir
Time frame: Days 2, 4, 6
Area Under the Curve (AUC) Adjusted by Baseline in Influenza Virus Titer in Participants Randomized to ZSP1273 or Placebo
Time frame: Up to 6 days after first dose
Area Under the Curve (AUC) Adjusted by Baseline in Influenza Virus Titer in Participants Randomized to ZSP1273 or Oseltamivir
Time frame: Up to 6 days after first dose
Time to Cessation of Viral Shedding Determined by Virus Titer in Participants Randomized to ZSP-1273 or Placebo
Time frame: Up to 6 days after first dose
Time to Cessation of Viral Shedding Determined by Virus Titer in Participants Randomized to ZSP1273 or Oseltamivir
Time frame: Up to 6 days after first dose
Time to Cessation of Viral Shedding Determined by Virus RNA in Participants Randomized to ZSP1273 or Placebo
Time frame: Up to 6 days after first dose
Time to Cessation of Viral Shedding Determined by Virus RNA in Participants Randomized to ZSP1273 or Oseltamivir
Time frame: Up to 6 days after first dose
Percentage of Participants Whose Symptoms Were Alleviated at Each Time Point in Participants Randomized to ZSP1273 or Placebo
Time frame: Up to 14 days after first dose
Percentage of Participants Whose Symptoms Were Alleviated at Each Time Point in Participants Randomized to ZSP1273 or Oseltamivir
Time frame: Up to 14 days after first dose
Time to Alleviation of the Four Systemic Symptoms in Participants Randomized to ZSP1273 or Placebo
Time frame: Up to 14 days after first dose
Time to Alleviation of the Four Systemic Symptoms in Participants Randomized to ZSP1273 or Oseltamivir
Time frame: Up to 14 days after first dose
Time to Alleviation of the Three Respiratory Symptoms in Participants Randomized to ZSP1273 or Placebo
Time frame: Up to 14 days after first dose
Time to Alleviation of the Three Respiratory Symptoms in Participants Randomized to ZSP1273 or Oseltamivir
Time frame: Up to 14 days after first dose
Change From Baseline in Composite Symptom Score at Each Time Point in Participants Randomized to ZSP1273 or Placebo
Time frame: Up to 14 days after first dose
Change From Baseline in Composite Symptom Score at Each Time Point in Participants Randomized to ZSP1273 or Oseltamivir
Time frame: Up to 14 days after first dose
Time to Resolution of Fever in Participants Randomized to ZSP1273 or Placebo
Time frame: Up to 14 days after first dose
Time to Resolution of Fever in Participants Randomized to ZSP1273 or Oseltamivir
Time frame: Up to 14 days after first dose
Percentage of Participants Reporting Normal Temperature at Each Time Point in Participants Randomized to ZSP1273 or Placebo
Time frame: Up to 14 days after first dose
Percentage of Participants Reporting Normal Temperature at Each Time Point in Participants Randomized to ZSP1273 or Oseltamivir
Time frame: Up to 14 days after first dose
Time to Alleviation of Individual Symptoms in Participants Randomized to ZSP1273 or Placebo
Time frame: Up to 14 days after first dose
Time to Alleviation of Individual Symptoms in Participants Randomized to ZSP1273 or Oseltamivir
Time frame: Up to 14 days after first dose
Time to Return to Preinfluenza Health Status in Participants Randomized to ZSP1273 or Placebo
Time frame: Up to 14 days after first dose
Time to Return to Preinfluenza Health Status in Adults Randomized to ZSP1273 or Oseltamivir
Time frame: Up to 14 days after first dose
Percentage of Participants With Influenza-related Complications in Participants Randomized to ZSP1273 or Placebo
Time frame: Up to 14 days after first dose
Percentage of Participants With Influenza-related Complications in Participants Randomized to ZSP1273 or Oseltamivir
Time frame: Up to 14 days after first dose
Change in EQ-5D-5L
Time frame: Up to 14 days after first dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Derived from this study: PubMed 40489986Yang 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.
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
76 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ZSP1273 600 mg and Oseltamivir(oral) in people with Influenza A, run by Guangdong Raynovent Biotech Co., Ltd at 76 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Alleviation of Symptoms in Participants Randomized to ZSP1273 or Placebo (time frame: Up to 14 days after first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04683406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.