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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04261270
Recruitment Status : Unknown
Verified March 2020 by Qin Ning, Tongji Hospital.
Recruitment status was:  Recruiting
First Posted : February 7, 2020
Last Update Posted : March 17, 2020
Information provided by (Responsible Party):
Qin Ning, Tongji Hospital

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

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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

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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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)

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 identifier (NCT number): NCT04261270

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Contact: Qing Ning, Professor +8613971521450
Contact: Meifang Han, Professor +8613986093605

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China, Hubei
Department and Institute of Infectious Disease Recruiting
Wuhan, Hubei, China, 430030
Contact: Qin Ning, professor   
Contact: Meifang Han, professor   
Sponsors and Collaborators
Tongji Hospital
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Responsible Party: Qin Ning, Professor, Tongji Hospital 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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Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
HIV Protease Inhibitors
Viral 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