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Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Novel Coronavirus Infection

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ClinicalTrials.gov Identifier: NCT04261907
Recruitment Status : Not yet recruiting
First Posted : February 10, 2020
Last Update Posted : February 10, 2020
Sponsor:
Collaborator:
Ascletis Pharmaceuticals Co., Ltd.
Information provided by (Responsible Party):
First Affiliated Hospital of Zhejiang University

Tracking Information
First Submitted Date  ICMJE February 6, 2020
First Posted Date  ICMJE February 10, 2020
Last Update Posted Date February 10, 2020
Estimated Study Start Date  ICMJE February 7, 2020
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2020)
The incidence of composite adverse outcome [ Time Frame: 14 days ]
Defined as(one of them) SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤ 300mmHg or RR ≥ 30 breaths per.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2020)
  • Time to recovery [ Time Frame: 14 days ]
    Clinical recovery was defined as( one of them): sustained (48 hours) alleviation of illness based on symptom scores (fever, cough,diarrhea, myalgia, dyspnea) all being absent and no evidence for progression (newly-presented dyspnea, SpO2 decline ≥3%, respiratory rate ≥ 24 breaths per min without supplemental oxygen). Or undectable viral RNA.
  • Rate of no fever [ Time Frame: 14 days ]
  • Rate of no cough [ Time Frame: 14 days ]
  • Rate of no dyspnea [ Time Frame: 14 days ]
  • Rate of no requring supplemental oxygen [ Time Frame: 14 days ]
  • Rate of undectable viral RNA [ Time Frame: 14 days ]
  • Rate of mechanical ventilation [ Time Frame: 14 days ]
  • Rate of ICU admission [ Time Frame: 14 days ]
  • Time and rate of laboratory indicators related to disease improvement to return to normal [ Time Frame: 14 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Novel Coronavirus Infection
Official Title  ICMJE A Randomized, Open-label, Multi-centre Clinical Trial Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Confirmed Cases of Pneumonia Caused by Novel Coronavirus Infection
Brief Summary Base on Arbidol antiviral therapy,the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of ASC09 /ritonavir and lopinavir/ritonavir in patients with 2019-nCoV pneumonia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE 2019-nCoV
Intervention  ICMJE
  • Drug: ASC09/ritonavir group
    ASC09/ritonavir(300mg/100mg tablet), one tablet each time, twice daily, for 14 days, +conventional standardized treatment
  • Drug: lopinavir/ritonavir group
    Lopinavir/ritonavir tablets(200mg / 50mg tablet), two tablets each time, twice daily, for 14 days, +conventional standardized treatment
Study Arms  ICMJE
  • Experimental: ASC09/ritonavir group
    ASC09/ritonavir (300mg/100mg tablet)+conventional standardized treatment
    Intervention: Drug: ASC09/ritonavir group
  • Active Comparator: lopinavir/ritonavir group
    Lopinavir/ritonavir tablet (200mg / 50mg tablet)+conventional standardized treatment
    Intervention: Drug: lopinavir/ritonavir group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 6, 2020)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. Aged between 18 and 75 years, extremes included, male or female
  • 2. Laboratory (RT-PCR) and clinical symptoms confirmed case of 2019-nCoV pneumonia, according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 5)"
  • 3. Hospitalised with a new onset respiratory illness (≤7 days since illness onset)
  • 4. No family planning within six months, and agree to take effective contraceptive measures throughout the study and for at least 30 days after the final study drug dose
  • 5. Must agree not to enroll in another study of an investigational agent prior to completion of Day 30 of study
  • 6. Informed Consent Form (ICF) signed voluntarily

Exclusion Criteria:

  • 1. Severe 2019-nCoV pneumonia met one of the following criteria: respiratory distress, RR ≥ 30 times / min, or SaO2 / SpO2 ≤ 93% in resting state, or arterial partial pressure of oxygen (PaO2) /concentration of oxygen (FiO2) ≤ 300mmHg (1mmHg = 0.133kpa)
  • 2. Critical severe 2019-nCoV pneumonia met one of the following criteria: respiratory failure and mechanical ventilation required, or shock, or combined with other organ failure required ICU monitoring treatment
  • 3. Severe liver disease (e.g. Child Pugh score ≥ C, AST > 5 times upper limit)
  • 4. Known allergic reaction to any of components of ASC09 / ritonavir compound tablets
  • 5. Patients with definite contraindications in the label of ritonavir
  • 6. Positive serum pregnancy test result for women with childbearing potential at screening
  • 7. Using HIV protease inhibitor drugs
  • 8. Not suitable for the study, in the opinion of the Investigator (e.g. patient may be transferred to another hospital during the study period, patient with multiple basic diseases, etc.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xiaowei Xu, Master +86 13605708066 xxw69@126.com
Contact: Jian Liu, Master +86 13958054006 lindaliu87@zju.edu.cn
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04261907
Other Study ID Numbers  ICMJE ASC09F-CTP-ZY-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party First Affiliated Hospital of Zhejiang University
Study Sponsor  ICMJE First Affiliated Hospital of Zhejiang University
Collaborators  ICMJE Ascletis Pharmaceuticals Co., Ltd.
Investigators  ICMJE
Principal Investigator: Yunqing Qiu, Master First Affiliated Hospital of Zhejiang University
PRS Account First Affiliated Hospital of Zhejiang University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP