Status:
COMPLETED
Evaluation of Ganovo （Danoprevir ） Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection
Lead Sponsor:
The Ninth Hospital of Nanchang
Collaborating Sponsors:
Ascletis Pharmaceuticals Co., Ltd.
Conditions:
COVID-19
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Evaluation of the efficacy and safety of Ganovo combined with ritonavir for patients infected with SARS-CoV-2.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Aged 18-75 years old;
- Pneumonia patients with new coronavirus infection were confirmed to be positive by RT-PCR and clinical manifestations. The diagnosis standard refers to the diagnosis and treatment plan for pneumonia with new coronavirus infection (Current Trial Version);
- Patients with newly diagnosed respiratory system discomfort who have been hospitalized (the diagnosis time of respiratory system discomfort shall not exceed 7 days);
- Women and their partners who have no planned pregnancy for nearly half a year and are willing to take effective contraceptive measures within 30 days from the first administration of the study drug to the last administration;
- Agree not to participate in other clinical research within 30 days from the first administration of the study drug to the last administration;
- Patients who voluntarily sign informed consent.
Exclusion
- The pneumonia patients with severe new coronavirus infection met one of the following conditions: respiratory distress, RR \>= 30 times / min; or SaO2 / SpO2 \<93% in resting state; or arterial partial pressure of oxygen (PaO2) / concentration of oxygen (FiO2) \<300MMHG (1mmhg = 0.133kpa);
- Pneumonia patients with severe new coronavirus infection meet one of the following conditions: respiratory failure and need mechanical ventilation; or shock; or other organ failure combined with ICU monitoring treatment;
- Severe liver disease (such as child Pugh score \>=C, AST \> 5 times upper limit);
- Patients with contraindications specified in the instructions of ritonavir tablets;
- The pregnancy test of female subjects in the screening period was positive;
- The researchers judged that it was not suitable to participate in this clinical trial (for example, patients who may be transferred to another hospital during the study period; patients with multiple basic diseases, etc.).
Key Trial Info
Start Date :
February 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2020
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04291729
Start Date
February 17 2020
End Date
March 19 2020
Last Update
April 13 2020
Active Locations (1)
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1
The Ninth Hospital of Nanchang
Nanchang, Jiangxi, China, 330000