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There were no more subjects enrolled.
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| Name | Class |
|---|---|
| Ascletis Pharmaceuticals Co., Ltd. | INDUSTRY |
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Base on Arbidol antiviral therapy,the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of ASC09 /ritonavir and lopinavir/ritonavir in patients with 2019-nCoV pneumonia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASC09/ritonavir group | Experimental | ASC09/ritonavir (300mg/100mg tablet)+conventional standardized treatment |
|
| lopinavir/ritonavir group | Active Comparator | Lopinavir/ritonavir tablet (200mg / 50mg tablet)+conventional standardized treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASC09/ritonavir group | Drug | ASC09/ritonavir(300mg/100mg tablet), one tablet each time, twice daily, for 14 days, +conventional standardized treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of composite adverse outcome | Defined as(one of them) SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤ 300mmHg or RR ≥ 30 breaths per. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to recovery | Clinical recovery was defined as( one of them): sustained (48 hours) alleviation of illness based on symptom scores (fever, cough,diarrhea, myalgia, dyspnea) all being absent and no evidence for progression (newly-presented dyspnea, SpO2 decline ≥3%, respiratory rate ≥ 24 breaths per min without supplemental oxygen). Or undectable viral RNA. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yunqing Qiu, Master | First Affiliated Hospital of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang Province, P.R. China | 310003 | China |
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| ID | Term |
|---|---|
| C000711727 | TMC-310911 |
| D061466 | Lopinavir |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| lopinavir/ritonavir group | Drug | Lopinavir/ritonavir tablets(200mg / 50mg tablet), two tablets each time, twice daily, for 14 days, +conventional standardized treatment |
|
| Rate of no fever | 14 days |
| Rate of no cough | 14 days |
| Rate of no dyspnea | 14 days |
| Rate of no requring supplemental oxygen | 14 days |
| Rate of undectable viral RNA | 14 days |
| Rate of mechanical ventilation | 14 days |
| Rate of ICU admission | 14 days |
| Time and rate of laboratory indicators related to disease improvement to return to normal | 14 days |