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

June 24, 2023 updated by: Guangdong Raynovent Biotech Co., Ltd

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

750

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China
        • The First Affiliated Hospital of Bengbu Medical College
        • Contact:
      • Xuancheng, Anhui, China
        • Xuancheng People's Hospital
        • Contact:
    • Beijing
      • Beijing, Beijing, China
        • Beijing Chaoyang Hospital,Capital Medical University
        • Contact:
      • Beijing, Beijing, China
        • Beijing Ditan Hospital Capital Medical University
        • Contact:
      • Beijing, Beijing, China
        • Peking University Third Hospital
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China
        • People's Hospital of Cuanjiang, Chongqing
        • Contact:
      • Chongqing, Chongqing, China
        • Third Military Medical University
        • Contact:
    • Fujian
      • Quanzhou, Fujian, China
        • Quanzhou First Hospital
        • Contact:
      • Xiamen, Fujian, China
        • Fujian Provincal Hospital
        • Contact:
      • Xiamen, Fujian, China
        • Xiamen Hospital of T.C.M
        • Contact:
      • Xiamen, Fujian, China
        • Xiamen Zhongshan Hospital
        • Contact:
    • Guangdong
      • Dongguan, Guangdong, China
        • Dongguan People's Hospital
        • Contact:
      • Foshan, Guangdong, China
        • Foshan First People's Hospital
        • Contact:
      • Foshan, Guangdong, China
        • Shunde University of Southern Medical University
        • Contact:
      • Guangzhou, Guangdong, China
        • Nanfang Hospital
        • Contact:
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Guangzhou, Guangdong, China
        • Guangdong Province Traditional Chinese Medical Hospital
        • Contact:
      • Guangzhou, Guangdong, China
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:
      • Huizhou, Guangdong, China
        • Huizhou Central People's Hospital
        • Contact:
      • Jieyang, Guangdong, China
        • Jieyang People's Hospital
        • Contact:
      • Qingyuan, Guangdong, China
        • Qingyuan People's Hospital
        • Contact:
      • Shantou, Guangdong, China
        • Shantou Central Hospital
        • Contact:
      • Shaoguan, Guangdong, China
        • Yuebei People's Hospital
        • Contact:
      • Shenzhen, Guangdong, China
        • Shenzhen Luohu Hospital Group Luohu People's Hospital
        • Contact:
      • Shenzhen, Guangdong, China
        • ShenZhen People's Hospital
        • Contact:
      • Shenzhen, Guangdong, China
        • Songgang People's Hospital
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China
        • Nanning First People's Hospital
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China
        • Guizhou Provicial People's Hospital
        • Contact:
      • Zunyi, Guizhou, China
        • Affiliated Hospital Zunyi Medical College
        • Contact:
    • Hebei
      • Qinhuangdao, Hebei, China
        • First Hospital of Qinhuangdao
        • Contact:
    • Henan
      • Huaihe, Henan, China
        • Huaihe Hospital of Henan University
        • Contact:
      • Luoyang, Henan, China
        • Luoyang Central Hospital Affiliated To Zhengzhou University
        • Contact:
      • Nanyang, Henan, China
        • Nanyang Central Hospital
        • Contact:
      • Nanyang, Henan, China
        • Nanyang First People's Hospital
        • Contact:
      • Nanyang, Henan, China
        • The Second People's hospital of Nanyang
        • Contact:
      • Nanyang, Henan, China
        • The Third Affiliated Hospital of Nanyang Medical College
        • Contact:
      • Xinxiang, Henan, China
        • The Third Affiliated Hospital of Xinxiang Medical University
        • Contact:
      • Zhengzhou, Henan, China
      • Zhengzhou, Henan, China
        • Zhengzhou Central Hospital
        • Contact:
      • Zhengzhou, Henan, China
        • Zhengzhou Sixth Hospital
        • Contact:
    • Hunan
      • Yiyang, Hunan, China
        • Yiyang Central Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Nanjing First Hospital
        • Contact:
      • Nanjing, Jiangsu, China
      • Nanjing, Jiangsu, China
        • Sir Run Run Hospital Nanjing Medical University
        • Contact:
      • Nanjing, Jiangsu, China
        • The Second Affiliated Hospital of Nanjing Medical University
        • Contact:
      • Xuzhou, Jiangsu, China
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
    • Jiangxi
      • Ganzhou, Jiangxi, China
        • First Affiliated Hospital of Gannan Medical University
        • Contact:
      • Jiujiang, Jiangxi, China
        • Jiujiang University Affiliated Hospital
        • Contact:
      • Nanchang, Jiangxi, China
        • First Affiliated Hospital of Nanchang University
        • Contact:
      • Nanchang, Jiangxi, China
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
      • Nanchang, Jiangxi, China
        • The Third Hospital of Nanchang
        • Contact:
      • Pingxiang, Jiangxi, China
        • Pingxiang People's Hospital
        • Contact:
      • Shangyao, Jiangxi, China
        • Shangyao People's Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China
        • The First Hospital of Jilin University
        • Contact:
    • Liaoning
      • Panjin, Liaoning, China
        • General Hospital of Liaohe Oilfield
        • Contact:
      • Shenyang, Liaoning, China
        • Shenyang Central Hospital Affiliated To Shenyang medical college
        • Contact:
    • Shandong
      • Binzhou, Shandong, China
        • Binzhou Medical University Hospital
        • Contact:
      • Heze, Shandong, China
        • Heze Municipal Hospital
        • Contact:
      • Jinan, Shandong, China
        • Jinan Central Hospital
        • Contact:
      • Liaocheng, Shandong, China
        • Liaocheng People's Hospital
        • Contact:
      • Linyi, Shandong, China
      • Zaozhuang, Shandong, China
        • Shandong Energy Zaozhuang Mining
        • Contact:
      • Zibo, Shandong, China
        • PKUCare Luzhong Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China
        • Shanghai East Hospital
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China
        • Shanxi Bethune Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Chengdu Xinhua Hospital
        • Contact:
      • Chengdu, Sichuan, China
        • General Hospital of Western Theater of PLA
        • Contact:
      • Chengdu, Sichuan, China
        • Sichuan Provicial People's Hospital
        • Contact:
      • Chengdu, Sichuan, China
        • The Third People's Hospital of Wuhou, Chengdu
        • Contact:
      • Chengdu, Sichuan, China
        • West China Hospital of Sichuan University
        • Contact:
      • Dazhou, Sichuan, China
      • Nanchong, Sichuan, China
        • Affiliated Hospital of North Sichuan College
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Medical University General Hospital
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China
        • The first People hospital of Yunnan Province
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
      • Ruian, Zhejiang, China
        • Ruian People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Description

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
  5. 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 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.
  11. 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
  12. Immunodeficiency,including malignant tumor,organ or marrow transplant,human immunodeficiency virus [HIV] infection,or patients receiving immunosuppressant therapy 3 months prior to enrollment.
  13. Concomitant therapy with aspirin or salicylic acid.
  14. Patients weighing < 40 kg or morbid obesity(Body mass index [BMI]≥30kg/m2)
  15. Known history of alcohol abuse or drug abuse
  16. 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.
  17. Have received any other investigational products within 3 months prior to dosing.
  18. Patients who, in the opinion of the investigator, would be unlikely to comply with required study visits, self-assessments, and interventions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ZSP1273 600 mg + Oseltamivir Placebo BID
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
Drug: ZSP1273 600 mg
3 X 200-mg tablet taken orally
Drug: Placebo to Oseltamivir
Placebo capsules matching oseltamivir2 X 75-mg
Active Comparator: Oseltamivir 75mg + ZSP1273 Placebo
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
Drug: Oseltamivir(oral)
2 X 75-mg tablet taken orally
Drug: Placebo to ZSP1273
Placebo capsules matching ZSP1273 600 mg
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
Drug: Placebo to Oseltamivir
Placebo capsules matching oseltamivir2 X 75-mg
Drug: Placebo to ZSP1273
Placebo capsules matching ZSP1273 600 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 14 days after first dose
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
Up to 14 days after first dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Virus titer was quantified from nasopharyngeal swabs by tissue culture methods.
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
Virus titer was quantified from nasopharyngeal swabs by tissue culture methods.
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
Influenza virus ribonucleic acid (RNA) was quantified from nasopharyngeal swabs.
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
Influenza virus ribonucleic acid (RNA) was quantified from nasopharyngeal swabs.
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
Virus titer was quantified from nasopharyngeal swabs.
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
Virus titer was quantified from nasopharyngeal swabs.
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
Nasopharyngeal swabs were obtained for viral quantitation.
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
Nasopharyngeal swabs were obtained for viral quantitation.
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
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
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
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
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
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
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
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
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
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)
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
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)
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

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.
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

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.
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
  • 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
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
  • 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
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
  • 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
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
  • 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
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 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
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
  • 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
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
Defined as the percentage of patients whose axillary temperature dropped to less than 37ºC after the initiation of study treatment
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
Defined as the percentage of patients whose axillary temperature dropped to less than 37ºC after the initiation of study treatment
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

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.
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

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.
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
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
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.
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
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.
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
Up to 14 days after first dose
Change in EQ-5D-5L
Time Frame: Up to 14 days after first dose
Defined as the change from baseline in the index value and that in EQ VAS score as calculated from the EQ-5D-5L questionnaire.
Up to 14 days after first dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Raynovent Biotech Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2020

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

May 16, 2023

Study Registration Dates

First Submitted

December 13, 2020

First Submitted That Met QC Criteria

December 20, 2020

First Posted (Actual)

December 24, 2020

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 24, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSP1273-20-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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