Clinical trial NCT04024137: Study of ZSP1273 in Patients With Acute Uncomplicated Influenza A
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 2 Study of ZSP1273 in Adults With Acute Uncomplicated Influenza A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza A
Lead sponsor: Guangdong Raynovent Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2019-07-18
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the antiviral effect, as measured by the time to alleviation of influenza symptoms and viral titer in nasopharyngeal secretions in adults with acute uncomplicated influenza A following administration of ZSP1273.


Eligibility criteria: Inclusion Criteria:

1. Males and female subjects between 18-65 years (Both inclusive).
2. Patients with a diagnosis of influenza virus A infection confirmed by all of the following:

   * Positive Rapid Antigen Test (RAT) with throat swabs;and
   * Fever≥38.0ºC (axillary) in the predose examinations;and
   * At least one of the following general systemic symptoms and respiratory symptoms respectively associated with influenza are present with a severity of moderate or greater:

     * General systemic symptoms:Headache,Feverishness or chills,Muscle or joint pain,Fatigue;
     * Respiratory symptoms:Cough,Sore throat,Nasal congestion.
3. The time interval between the onset of symptoms and the enrollment is≤48 hours. The onset of symptoms is defined as:

   * Time of the first increase in body temperature(axillary temperature≥38.0ºC),or
   * Time when the patient experiences at least one general or respiratory symptom.
4. Subjects who agree to use an appropriate method of contraception during the study and up to 6 months after drug withdrawal.
5. Signature of a dated Informed Consent Form (ICF) indicating that the subject has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.

Exclusion Criteria:

1. Known hypersensitivity and/or allergy to some drugs and food,especially for the composition that is similar to ZSP1273;
2. Dysphagia or any medical history in gastrointestinal that interferes with the absorption of drugs.
3. Use of the following medications within 7 days prior to screening:

   * Influenza antiviral medication:oseltamivir,peramivir,famivir,abidol,amantadine or rimantadine.
   * Chinese patent medicine or herbal medicine with antiviral effect.
4. Patients who have received influenza vaccine within 6 months prior to enrollment.
5. Presence of clinically significant abnormalities in ECG .
6. Chest X - ray examination confirmed bronchitis,pneumonia,pleural effusion or pulmonary interstitial lesions.
7. Patients who have experienced respiratory tract infection,Otitis media,nasosinusitis.
8. White blood cells(WBC)\>10.0×109/L at screening.
9. Subject who produces purulent sputum or has suppurative tonsillitis.
10. 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.
11. Immunodeficiency,including malignant tumor,organ or marrow transplant,human immunodeficiency virus \[HIV\] infection,or patients receiving immunosuppressant therapy 3 months prior to enrollment.
12. Concomitant therapy with aspirin or salicylic acid.
13. Morbid obesity(Body mass index \[BMI\]≥30kg/m2).
14. Known history of alcohol abuse or drug abuse.
15. 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.
16. Have received any other investigational products within 3 months prior to dosing.
17. Subjects who should not be included in the study in the opinion of the Investigator.

Primary outcomes:
measure: Time to alleviation of influenza symptoms in participants
timeFrame: Initiation of study treatment (Day 1) up to Day 15
Secondary outcomes:
measure: AUC of the log10 pharyngeal viral load
timeFrame: Days 6
measure: Change in the total score of 7 influenza symptoms
timeFrame: Up to Day15
measure: Time to alleviation of each influenza symptom.
timeFrame: Up to Day15
measure: Time to Resolution of Fever
timeFrame: Up to Day15
measure: Proportion of patients reporting normal temperature
timeFrame: Up to Day15
measure: Percentage of subjects with virus titer detected
timeFrame: Days 2,4, 6
measure: Duration of detectable virus
timeFrame: Days 2,4, 6
measure: Change in virus titer
timeFrame: Days 2,4, 6
measure: Change in viral RNA load
timeFrame: Days 2,4, 6
measure: Incidence of influenza-related complications
timeFrame: Up to Day21
measure: Time to return to normal activities of daily life
timeFrame: Up to Day15
measure: Proportion of patients with the Serological conversion of neutralizing antibody titer relative to that in Visit 1 ≥4
timeFrame: Baseline and Day 21
measure: Proportion of patients and frequency in combination use of acetaminophen.
timeFrame: Up to 21 days post-dose
measure: Change in EQ-5D-5L
timeFrame: Baseline up to Day 15
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Hospital Of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Ditan Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Luhe Hospital,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
state: Fujian
city: Dongguan
country: China
facility: Dongguan people's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital,South Medical Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital Of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Traditional Chinese Medicine Hospital of Guangdong Province
state: Guangdong
city: Huizhou
country: China
facility: Huizhou Municipal Central Hospital
state: Guangdong
city: Jieyang
country: China
facility: Jieyang People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Zhanjiang
country: China
facility: Affiliated Hospital Of Guangdong Medical University
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The Sixth People's Hospital Of Zhengzhou
state: Henan
city: Nanjing
country: China
facility: Sir Run Run Hospital Nanjing Medical University
state: Jiangsu
city: Jiujiang
country: China
facility: Jiujiang University Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital Of Nanchang University
state: Jiangxi
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Linyi
country: China
facility: Linyi People's Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: Chengdu Fifth People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: General Hospital, Tianjin Medical University
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital,Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
Study officials:
References: