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

Sponsor
Guangdong Raynovent Biotech Co., Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04683406
Collaborator
(none)
744
76
3
6
9.8
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
744 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind Phase III Clinical Study of ZSP1273 Tablets Compared With Placebo or Oseltamivir Patients With Acute Uncomplicated Influenza A
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Time to Alleviation of Symptoms in Participants Randomized to ZSP1273 or Placebo [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

  2. Time to Alleviation of Symptoms in Participants Randomized to ZSP1273 or Oseltamivir [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 Outcome Measures

  1. Percentage of Participants With Positive Influenza Virus Titer at Each Time Point in Participants Randomized to ZSP1273 or Placebo [Days 2, 4, 6]

    Virus titer was quantified from nasopharyngeal swabs by tissue culture methods.

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

    Virus titer was quantified from nasopharyngeal swabs by tissue culture methods.

  3. 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]

    Influenza virus ribonucleic acid (RNA) was quantified from nasopharyngeal swabs.

  4. 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]

    Influenza virus ribonucleic acid (RNA) was quantified from nasopharyngeal swabs.

  5. Change From Baseline in Virus Titer at Each Time Point in Participants Randomized to ZSP1273 or Placebo [Days 2, 4, 6]

    Virus titer was quantified from nasopharyngeal swabs.

  6. Change From Baseline in Virus Titer at Each Time Point in Participants Randomized to ZSP1273 or Oseltamivir [Days 2, 4, 6]

    Virus titer was quantified from nasopharyngeal swabs.

  7. Change From Baseline in Virus RNA (RT-PCR) at Each Time Point in Participants Randomized to ZSP1273 or Placebo [Days 2, 4, 6]

    Nasopharyngeal swabs were obtained for viral quantitation.

  8. Change From Baseline in Virus RNA (RT-PCR) at Each Time Point in Participants Randomized to ZSP1273 or Oseltamivir [Days 2, 4, 6]

    Nasopharyngeal swabs were obtained for viral quantitation.

  9. 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]

    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

  10. 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]

    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

  11. 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]

  12. Time to Cessation of Viral Shedding Determined by Virus Titer in Participants Randomized to ZSP1273 or Oseltamivir [Up to 6 days after first dose]

  13. Time to Cessation of Viral Shedding Determined by Virus RNA in Participants Randomized to ZSP1273 or Placebo [Up to 6 days after first dose]

  14. Time to Cessation of Viral Shedding Determined by Virus RNA in Participants Randomized to ZSP1273 or Oseltamivir [Up to 6 days after first dose]

  15. 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]

    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)

  16. 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]

    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)

  17. Time to Alleviation of the Four Systemic Symptoms in Participants Randomized to ZSP1273 or Placebo [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.

  18. Time to Alleviation of the Four Systemic Symptoms in Participants Randomized to ZSP1273 or Oseltamivir [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.

  19. Time to Alleviation of the Three Respiratory Symptoms in Participants Randomized to ZSP1273 or Placebo [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

  20. Time to Alleviation of the Three Respiratory Symptoms in Participants Randomized to ZSP1273 or Oseltamivir [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

  21. 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]

    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

  22. 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]

    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

  23. Time to Resolution of Fever in Participants Randomized to ZSP1273 or Placebo [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

  24. Time to Resolution of Fever in Participants Randomized to ZSP1273 or Oseltamivir [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

  25. Percentage of Participants Reporting Normal Temperature at Each Time Point in Participants Randomized to ZSP1273 or Placebo [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

  26. Percentage of Participants Reporting Normal Temperature at Each Time Point in Participants Randomized to ZSP1273 or Oseltamivir [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

  27. Time to Alleviation of Individual Symptoms in Participants Randomized to ZSP1273 or Placebo [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.

  28. Time to Alleviation of Individual Symptoms in Participants Randomized to ZSP1273 or Oseltamivir [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.

  29. Time to Return to Preinfluenza Health Status in Participants Randomized to ZSP1273 or Placebo [Up to 14 days after first dose]

  30. Time to Return to Preinfluenza Health Status in Adults Randomized to ZSP1273 or Oseltamivir [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.

  31. Percentage of Participants With Influenza-related Complications in Participants Randomized to ZSP1273 or Placebo [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.

  32. Percentage of Participants With Influenza-related Complications in Participants Randomized to ZSP1273 or Oseltamivir [Up to 14 days after first dose]

  33. Change in EQ-5D-5L [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. 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

  1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of bengbu medical college Bengbu Anhui China
2 Xuancheng People's Hospital Xuancheng Anhui China
3 Beijing Chaoyang Hospital,Capital Medical University Beijing Beijing China
4 Beijing Ditan Hospital Capital Medical University Beijing Beijing China
5 Peking University Third Hospital Beijing Beijing China
6 People's Hospital of Cuanjiang, Chongqing Chongqing Chongqing China
7 Third Military Medical University Chongqing Chongqing China
8 Quanzhou First Hospital Quanzhou Fujian China
9 Fujian Provincal Hospital Xiamen Fujian China
10 Xiamen Hospital of T.C.M Xiamen Fujian China
11 Xiamen Zhongshan Hospital Xiamen Fujian China
12 Dongguan People's Hospital Dongguan Guangdong China
13 Foshan First People's Hospital Foshan Guangdong China
14 Shunde University of Southern Medical University Foshan Guangdong China
15 Guangdong Province Traditional Chinese Medical Hospital Guangzhou Guangdong China
16 Nanfang Hospital Guangzhou Guangdong China
17 Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong China
18 The First Affiliated Hospital Of Guangzhou Medical University Guangzhou Guangdong China
19 Huizhou Central People's Hospital Huizhou Guangdong China
20 Jieyang People's Hospital Jieyang Guangdong China
21 Qingyuan People's Hospital Qingyuan Guangdong China
22 Shantou Central Hospital Shantou Guangdong China
23 Yuebei People's Hospital Shaoguan Guangdong China
24 Shenzhen Luohu Hospital Group Luohu People's Hospital Shenzhen Guangdong China
25 Shenzhen People's Hospital Shenzhen Guangdong China
26 Songgang People's Hospital Shenzhen Guangdong China
27 Nanning First People's Hospital Nanning Guangxi China
28 Guizhou Provicial People's Hospital Guiyang Guizhou China
29 Affiliated Hospital Zunyi Medical College Zunyi Guizhou China
30 First Hospital of Qinhuangdao Qinhuangdao Hebei China
31 Huaihe Hospital of Henan University Huaihe Henan China
32 Luoyang Central Hospital Affiliated To Zhengzhou University Luoyang Henan China
33 Nanyang Central Hospital Nanyang Henan China
34 Nanyang First People's Hospital Nanyang Henan China
35 The Second People's hospital of Nanyang Nanyang Henan China
36 The Third Affiliated Hospital of Nanyang Medical College Nanyang Henan China
37 The Third Affiliated Hospital of Xinxiang Medical University Xinxiang Henan China
38 Henan Provicial People's Hospital Zhengzhou Henan China
39 Zhengzhou Central Hospital Zhengzhou Henan China
40 Zhengzhou Sixth Hospital Zhengzhou Henan China
41 Yiyang Central hospital Yiyang Hunan China
42 Nanjing First Hospital Nanjing Jiangsu China
43 Nanjing Jiangning Hospital Nanjing Jiangsu China
44 Sir run run Hospital Nanjing Medical University Nanjing Jiangsu China
45 The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China
46 The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu China
47 First Affiliated Hospital of Gannan Medical University Ganzhou Jiangxi China
48 Jiujiang University Affiliated Hospital Jiujiang Jiangxi China
49 First Affiliated Hospital of Nanchang University Nanchang Jiangxi China
50 The Second Affiliated Hospital Of Nanchang University Nanchang Jiangxi China
51 The Third Hospital Of Nanchang Nanchang Jiangxi China
52 Pingxiang People's Hospital Pingxiang Jiangxi China
53 Shangyao People's Hospital Shangyao Jiangxi China
54 The First Hospital Of Jilin University Changchun Jilin China
55 General Hospital of Liaohe Oilfield Panjin Liaoning China
56 Shenyang Central Hospital Affiliated To Shenyang medical college Shenyang Liaoning China
57 Binzhou Medical University Hospital Binzhou Shandong China
58 Heze Municipal Hospital Heze Shandong China
59 Jinan Central Hospital Jinan Shandong China
60 Liaocheng People's Hospital Liaocheng Shandong China
61 Linyi People's Hospital Linyi Shandong China
62 Shandong Energy Zaozhuang Mining Zaozhuang Shandong China
63 PKUCare luzhong Hospital Zibo Shandong China
64 Shanghai East Hospital Shanghai Shanghai China
65 Shanxi Bethune Hospital Taiyuan Shanxi China
66 Chengdu Xinhua Hospital Chengdu Sichuan China
67 General Hospital of Western Theater of PLA Chengdu Sichuan China
68 Sichuan Provicial People's Hospital Chengdu Sichuan China
69 The Third People's Hospital of Wuhou, Chengdu Chengdu Sichuan China
70 West China Hospital of Sichuan University Chengdu Sichuan China
71 Dazhou Central Hospital Dazhou Sichuan China
72 Affiliated Hospital of North Sichuan College Nanchong Sichuan China
73 Tianjin Medical University General Hospital Tianjin Tianjin China
74 The first People hospital of Yunnan Province Kunming Yunnan China
75 The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang China
76 Ruian People's Hospital Ruian Zhejiang China

Sponsors and Collaborators

  • Guangdong Raynovent Biotech Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guangdong Raynovent Biotech Co., Ltd
ClinicalTrials.gov Identifier:
NCT04683406
Other Study ID Numbers:
  • ZSP1273-20-06
First Posted:
Dec 24, 2020
Last Update Posted:
Jul 28, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2021