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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASC09F+Oseltamivir | Experimental |
| |
| Ritonavir+Oseltamivir | Experimental |
| |
| Oseltamivir | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASC09F+Oseltamivir | Drug | ASC09F tablets:one tablet(400mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of comprehensive adverse outcome | The definition of comprehensive adverse outcome is as follows:
| 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time of clinical remission | The definition of clinical remission:
| 28 days |
| Rate of no fever |
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Inclusion Criteria:
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)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qing Ning, Professor | Contact | +8613971521450 | qning@vip.sina.com | |
| Meifang Han, Professor | Contact | +8613986093605 | mfhan@foxmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department and Institute of Infectious Disease | Recruiting | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
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| Ritonavir+Oseltamivir | Drug | Ritonavir tablet:three tablets(100mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day |
|
| Oseltamivir | Drug | 75mg ,once a day |
|
| 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 |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |