A Randomized, Double-blind Phase III Clinical Study of ZSP1273 Tablets Compared With Placebo or Oseltamivir Patients With Acute Uncomplicated Influenza A
Overview
- Phase
- Phase 3
- Intervention
- ZSP1273 600 mg
- Conditions
- Influenza A
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd
- Enrollment
- 750
- Locations
- 76
- Primary Endpoint
- Time to Alleviation of Symptoms in Participants Randomized to ZSP1273 or Placebo
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
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
Intervention: ZSP1273 600 mg
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
Intervention: Placebo to Oseltamivir
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
Intervention: Oseltamivir(oral)
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
Intervention: Placebo to ZSP1273
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
Intervention: Placebo to Oseltamivir
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
Intervention: Placebo to ZSP1273
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Change From Baseline in Virus RNA (RT-PCR) at Each Time Point in Participants Randomized to ZSP1273 or Oseltamivir(Days 2, 4, 6)
- Percentage of Participants Reporting Normal Temperature at Each Time Point in Participants Randomized to ZSP1273 or Placebo(Up to 14 days after first dose)
- Percentage of Participants Reporting Normal Temperature at Each Time Point in Participants Randomized to ZSP1273 or Oseltamivir(Up to 14 days after first dose)
- 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 Oseltamivir(Days 2, 4, 6)
- Change From Baseline in Virus RNA (RT-PCR) at Each Time Point in Participants Randomized to ZSP1273 or Placebo(Days 2, 4, 6)
- Time to Cessation of Viral Shedding Determined by Virus Titer in Participants Randomized to ZSP1273 or Oseltamivir(Up to 6 days after first dose)
- Time to Cessation of Viral Shedding Determined by Virus RNA in Participants Randomized to ZSP1273 or Oseltamivir(Up to 6 days after first dose)
- Percentage of Participants With Positive Influenza Virus Titer at Each Time Point in Participants Randomized to ZSP1273 or Placebo(Days 2, 4, 6)
- Time to Resolution of Fever in Participants Randomized to ZSP1273 or Oseltamivir(Up to 14 days after first dose)
- Time to Alleviation of Individual Symptoms in Participants Randomized to ZSP1273 or Placebo(Up to 14 days after first dose)
- Percentage of Participants With Positive Influenza Virus Titer 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)
- Area Under the Curve (AUC) Adjusted by Baseline in Influenza Virus Titer in Participants Randomized to ZSP1273 or Placebo(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(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(Up to 6 days after first dose)
- Time to Alleviation of the Four Systemic Symptoms in Participants Randomized to ZSP1273 or Oseltamivir(Up to 14 days after first dose)
- Time to Alleviation of the Three Respiratory Symptoms in Participants Randomized to ZSP1273 or Placebo(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(Up to 14 days after first dose)
- 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)
- Time to Cessation of Viral Shedding Determined by Virus RNA in Participants Randomized to ZSP1273 or Placebo(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(Up to 14 days after first dose)
- Percentage of Participants With Influenza-related Complications in Participants Randomized to ZSP1273 or Oseltamivir(Up to 14 days after first dose)
- Change in EQ-5D-5L(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(Up to 14 days after first dose)
- Time to Alleviation of the Four Systemic Symptoms in Participants Randomized to ZSP1273 or Placebo(Up to 14 days after first dose)
- Time to Alleviation of the Three Respiratory Symptoms in Participants Randomized to ZSP1273 or Oseltamivir(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(Up to 14 days after first dose)
- Time to Resolution of Fever in Participants Randomized to ZSP1273 or Placebo(Up to 14 days after first dose)
- Time to Return to Preinfluenza Health Status in Participants Randomized to ZSP1273 or Placebo(Up to 14 days after first dose)
- Time to Return to Preinfluenza Health Status in Adults Randomized to ZSP1273 or Oseltamivir(Up to 14 days after first dose)
- Percentage of Participants With Influenza-related Complications in Participants Randomized to ZSP1273 or Placebo(Up to 14 days after first dose)
- Time to Alleviation of Individual Symptoms in Participants Randomized to ZSP1273 or Oseltamivir(Up to 14 days after first dose)