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A Randomized,Open,Controlled Clinical Study to Evaluate the Efficacy of ASC09F and Ritonavir for 2019-nCoV Pneumonia

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ClinicalTrials.gov Identifier: NCT04261270
Recruitment Status : Recruiting
First Posted : February 7, 2020
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Qin Ning, Tongji Hospital

Tracking Information
First Submitted Date  ICMJE February 4, 2020
First Posted Date  ICMJE February 7, 2020
Last Update Posted Date March 17, 2020
Actual Study Start Date  ICMJE February 1, 2020
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2020)
Rate of comprehensive adverse outcome [ Time Frame: 14 days ]
The definition of comprehensive adverse outcome is as follows:
  1. SPO2≤93% without oxygen inhalation;
  2. PaO2/FiO2≤300mmHg;
  3. RR≥30 bpm without oxygen inhalation.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2020)
  • Time of clinical remission [ Time Frame: 28 days ]
    The definition of clinical remission:
    1. Based on the symptoms of the disease (fever,cough,diarrhea,myalgia,dyspnea) has been relieved for 48 hours;
    2. There is no evidence of disease progression(New dyspnea, SpO2 decreased≥3%,RR≥30 bpm without oxygen inhalation).
  • 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 need for oxygen inhalation [ Time Frame: 14 days ]
  • Rate of undetectable viral RNA [ Time Frame: 14 days ]
  • Rate of mechanical ventilation [ Time Frame: 28 days ]
  • Rate of ICU admission [ Time Frame: 28 days ]
  • Rate and time of CRP,ES,Biochemical criterion(CK,ALT,Mb)recovery [ Time Frame: 28 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 A Randomized,Open,Controlled Clinical Study to Evaluate the Efficacy of ASC09F and Ritonavir for 2019-nCoV Pneumonia
Official Title  ICMJE A Randomized,Open,Controlled Small Sample Clinical Study to Evaluate the Efficacy and Safety of ASC09/Ritonavir Compound Tablets and Ritonavir for 2019-nCoV Pneumonia
Brief Summary Based on oseltamivir treatment, evaluate the efficacy and safety of ASC09/ritonavir compound tablets(ASC09F) or ritonavir tablets for 2019-nCoV infection patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE 2019-nCoV Pneumonia
Intervention  ICMJE
  • Drug: ASC09F+Oseltamivir
    ASC09F tablets:one tablet(400mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day
  • Drug: Ritonavir+Oseltamivir
    Ritonavir tablet:three tablets(100mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day
  • Drug: Oseltamivir
    75mg ,once a day
Study Arms  ICMJE
  • Experimental: ASC09F+Oseltamivir
    Intervention: Drug: ASC09F+Oseltamivir
  • Experimental: Ritonavir+Oseltamivir
    Intervention: Drug: Ritonavir+Oseltamivir
  • Experimental: Oseltamivir
    Intervention: Drug: Oseltamivir
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 6, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2020
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age:18~55 years old, unlimited gender.
  2. Laboratory (RT-PCR) confirmed infection with 2019-nCoV and accompanied with clinical manifestations.
  3. Patients with newly diagnosed respiratory discomfort who have been hospitalized (The proper diagnosis time is less than 7 days).
  4. Women who have no planned pregnancy in the next six months,and are willing to take effective measures to prevent contraception from the first dose of study drug to 30 days after the last dose.
  5. Agree not to participate in other clinical studies within 30 days from the first dose of the study drug to the last dose.
  6. Patients who voluntarily sign informed consent forms.

Exclusion Criteria:

1.2019-nCoV severe Pneumonia patients.

Meet the definition of severe pneumonia(Comply with any of the followings):

  1. Respiratory distress ,RR≥30 bpm;
  2. In a resting state:SPO2≤93%;
  3. PaO2/ FiO2≤300mmHg.

    2.2019-nCoV critical and severe Pneumonia patients.Comply with any of the followings:Respiratory failure and need mechanical ventilation;Shock;Patients combined with other organ failure need ICU monitoring and treatment.

    3.Severe liver disease(such as:the ChildPugh score≥C;AST > 5 times the upper limit).

    4.Patients who are allergic to the ingredients of ASC09/ritonavir compound tablets.

    5.Patients with definite contraindications in ritonavir tablets.

    6.Female subjects were positive for the pregnancy test during the screening period.

    7.Researcher judges unsuitable for participation in this clinical trial(such as:during the study patients may be transferred to hospital for treatment;patients with multiple underlying diseases, etc)

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Qing Ning, Professor +8613971521450 qning@vip.sina.com
Contact: Meifang Han, Professor +8613986093605 mfhan@foxmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04261270
Other Study ID Numbers  ICMJE ASC09F-CTP-TJ-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: Undecided
Responsible Party Qin Ning, Tongji Hospital
Study Sponsor  ICMJE Tongji Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tongji Hospital
Verification Date March 2020

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