Evaluation of Ganovo （Danoprevir ） Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection

• Status: Completed
• Trial end date: 2020-03-19
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of the efficacy and safety of Ganovo combined with ritonavir for patients infected with SARS-CoV-2.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Ninth Hospital of Nanchang
• Collaborator: Ascletis Pharmaceuticals Co., Ltd.
• Treatments: Interferons; Lopinavir; Peginterferon alfa-2a; Ritonavir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.).