Evaluation of the efficacy and safety of Danoprevir sodium tablet combined with ritonavir for SARS-CoV-2 infected patients.
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 will evaluate the efficacy and safety of Danoprevir sodium tablet in
hospitalized patients infected with SARS-CoV-2.
Drug: Danoprevir+Ritonavir
Danoprevir 100mg , one tablet each time , twice per day, up to 10 days. Ritonavir 100mg, one tablet each time , twice per day, up to 10 days.
Other Name: Ganovo
Inclusion Criteria:
1. Aged 18-75 years old;
2. 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);
3. Patients with newly diagnosed respiratory system discomfort who have been hospitalized
(the diagnosis time of respiratory system discomfort shall not exceed 7 days);
4. 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;
5. Agree not to participate in other clinical research within 30 days from the first
administration of the study drug to the last administration;
6. Patients who voluntarily sign informed consent.
Exclusion Criteria:
1. 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);
2. 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;
3. Severe liver disease (such as child Pugh score ≥C, AST > 5 times upper limit);
4. Patients with contraindications specified in the instructions of danoprevir and
ritonavir tablets;
5. Patients who plan to take protease inhibitors other than danoprevir and ritonavir
simultaneously during the trial.
6. The pregnancy test of female subjects in the screening period was positive;
7. 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.).
Huoshenshan Hostipal
Wuhan, Hubei, China
Yahong Chen, MD, Study Director
Ascletis Pharmaceuticals Co., Ltd.