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

Guangdong Raynovent Biotech

Status and phase: Completed; Phase 3

Conditions: Influenza A

Treatments: Drug: Placebo to ZSP1273; Drug: Oseltamivir(oral); Drug: Placebo to Oseltamivir; Drug: ZSP1273 600 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04683406

ZSP1273-20-06

Details and patient eligibility

About

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.

Enrollment: 750 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

750 participants in 3 patient groups, including a placebo group

ZSP1273 600 mg + Oseltamivir Placebo BID

Experimental group

Description:

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

Treatment:

Drug: ZSP1273 600 mg

Drug: Placebo to Oseltamivir

Oseltamivir 75mg + ZSP1273 Placebo

Active Comparator group

Description:

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

Treatment:

Drug: Oseltamivir(oral)

Drug: Placebo to ZSP1273

Placebo Comparator

Placebo Comparator group

Description:

Subjects received 5 doses of matching placebo of ZSP1273 and Oseltamivir twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5 days

Treatment:

Drug: Placebo to ZSP1273

Drug: Placebo to Oseltamivir