Status:
COMPLETED
Efficacy and Safety of Ganovo (Danoprevir) Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection
Lead Sponsor:
Huoshenshan Hospital
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 Danoprevir sodium tablet combined with ritonavir for SARS-CoV-2 infected patients.
Detailed Description
Given no specific antiviral therapies for COVID-19 approved yet and Danoprevir sodium tablet, 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 SARS-CoV-2 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 SARS-CoV-2 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 SARS-CoV-2 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 SARS-CoV-2 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 danoprevir and ritonavir tablets;
- Patients who plan to take protease inhibitors other than danoprevir and ritonavir simultaneously during the trial.
- 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 :
March 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04345276
Start Date
March 18 2020
End Date
April 15 2020
Last Update
June 2 2020
Active Locations (1)
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1
Huoshenshan Hostipal
Wuhan, Hubei, China, 430104