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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
2019-nCoV Pneumonia Drug: ASC09F+Oseltamivir Drug: Ritonavir+Oseltamivir Drug: Oseltamivir Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arms and Interventions
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Arm Intervention/treatment
Experimental: ASC09F+Oseltamivir Drug: ASC09F+Oseltamivir
ASC09F tablets:one tablet(400mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day
Experimental: Ritonavir+Oseltamivir Drug: Ritonavir+Oseltamivir
Ritonavir tablet:three tablets(100mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day
Experimental: Oseltamivir Drug: Oseltamivir
75mg ,once a day


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. Rate of no fever [ Time Frame: 14 days ]
  3. Rate of no cough [ Time Frame: 14 days ]
  4. Rate of no dyspnea [ Time Frame: 14 days ]
  5. Rate of no need for oxygen inhalation [ Time Frame: 14 days ]
  6. Rate of undetectable viral RNA [ Time Frame: 14 days ]
  7. Rate of mechanical ventilation [ Time Frame: 28 days ]
  8. Rate of ICU admission [ Time Frame: 28 days ]
  9. Rate and time of CRP,ES,Biochemical criterion(CK,ALT,Mb)recovery [ Time Frame: 28 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04261270


Contacts
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Contact: Qing Ning, Professor +8613971521450 qning@vip.sina.com
Contact: Meifang Han, Professor +8613986093605 mfhan@foxmail.com

Locations
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China, Hubei
Department and Institute of Infectious Disease Recruiting
Wuhan, Hubei, China, 430030
Contact: Qin Ning, professor       qning@vip.sina.com   
Contact: Meifang Han, professor       mfhan@foxmail.com   
Sponsors and Collaborators
Tongji Hospital
More Information
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Responsible Party: Qin Ning, Professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT04261270    
Other Study ID Numbers: ASC09F-CTP-TJ-01
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ritonavir
Oseltamivir
HIV Protease Inhibitors
Protease Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors