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| Name | Class |
|---|---|
| Ascletis Pharmaceuticals Co., Ltd. | INDUSTRY |
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Evaluation of the efficacy and safety of Ganovo combined with ritonavir for patients infected with SARS-CoV-2.
Given no specific antiviral therapies for new coronavirus pneumonia approved yet and Ganovo, an oral Hepatitis C virus protease inhibitor, approved in China in June 2018 , this open, controlled trial will evaluate the efficacy and safety of Ganovo in hospitalized patients infected with SARS-CoV-2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ganovo+ritonavir with or without interferon nebulization | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ganovo+ritonavir+/-Interferon nebulization | Drug | Ganovo one tablet (100mg / tablet) at a time, twice a day, up to 14 days. Ritonavir one tablet(100mg / tablet) at a time, twice a day, up to 14 days.With or without spray inhalation of interferon, 50μg / time for adults, twice a day up to 14 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of composite adverse outcomes | Defined as SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤300mmHg or a respiratory rate ≥30 breaths per min without supplemental oxygen | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to recovery | Clinical recovery was defined as 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). | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yahong Chen, MD | Ascletis Pharmaceuticals Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ninth Hospital of Nanchang | Nanchang | Jiangxi | 330000 | China |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
| Rate of no fever |
Rate of no fever |
| 14 days |
| Rate of no cough | Rate of no cough | 14 days |
| Rate of no dyspnea | Rate of no dyspnea | 14 days |
| Rate of no requiring supplemental oxygen | Rate of no requiring supplemental oxygen | 14 days |
| Rate of undetectable New coronavirus pathogen nucleic acid | Rate of undetectable New coronavirus pathogen nucleic acid | 14 days |
| Rate of mechanical ventilation | Rate of mechanical ventilation | 14 days |
| Rate of ICU admission | Rate of ICU admission | 14 days |
| Rate of serious adverse event | Rate of serious adverse event | 14 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |