A Study of ZSP1273 Tablets in Patients With Acute Uncompl... | NCT04683406

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	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	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	Drug: Placebo to Oseltamivir Drug: Placebo to ZSP1273

Name	Type	Description	Arm Group Labels	Other Names
ZSP1273 600 mg	Drug	3 X 200-mg tablet taken orally	ZSP1273 600 mg + Oseltamivir Placebo BID

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.	Days 2, 4, 6
Percentage of Participants With Positive Influenza Virus Titer at Each Time Point in Participants Randomized to ZSP1273 or Oseltamivir

Eligibility Module

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
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:

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
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

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of bengbu medical college		Bengbu	Anhui		China
Xuancheng People's Hospital