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

Study Overview
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Brief Summary
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Based on oseltamivir treatment, evaluate the efficacy and safety of ASC09/ritonavir compound tablets(ASC09F) or ritonavir tablets for 2019-nCoV infection patients.

Official Title
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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

Conditions
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2019-nCoV Pneumonia

Intervention / Treatment
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* Drug: ASC09F+Oseltamivir
* Drug: Ritonavir+Oseltamivir
* Drug: Oseltamivir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age:18 55 years old, unlimited gender. Laboratory (RT-PCR) confirmed infection with 2019-nCoV and accompanied with clinical manifestations. Patients with newly diagnosed respiratory discomfort who have been hospitalized (The proper diagnosis time is less than 7 days). 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. Agree not to participate in other clinical studies within 30 days from the first dose of the study drug to the last dose. 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): Respiratory distress ,RR≥30 bpm; In a resting state:SPO2≤93%; 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASC09F+Oseltamivir<br> | Drug: ASC09F+Oseltamivir<br>* ASC09F tablets:one tablet(400mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day<br>|
| Experimental: Ritonavir+Oseltamivir<br> | Drug: Ritonavir+Oseltamivir<br>* Ritonavir tablet:three tablets(100mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day<br>|
| Experimental: Oseltamivir<br> | Drug: Oseltamivir<br>* 75mg ,once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of comprehensive adverse outcome | The definition of comprehensive adverse outcome is as follows: SPO2≤93% without oxygen inhalation; PaO2/FiO2≤300mmHg; RR≥30 bpm without oxygen inhalation. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of clinical remission | The definition of clinical remission: Based on the symptoms of the disease (fever,cough,diarrhea,myalgia,dyspnea) has been relieved for 48 hours; There is no evidence of disease progression(New dyspnea, SpO2 decreased≥3%,RR≥30 bpm without oxygen inhalation). | 28 days | 
| Rate of no fever |  | 14 days | 
| Rate of no cough |  | 14 days | 
| Rate of no dyspnea |  | 14 days | 
| Rate of no need for oxygen inhalation |  | 14 days | 
| Rate of undetectable viral RNA |  | 14 days | 
| Rate of mechanical ventilation |  | 28 days | 
| Rate of ICU admission |  | 28 days | 
| Rate and time of CRP,ES,Biochemical criterion(CK,ALT,Mb)recovery |  | 28 days |