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

• Status: Completed
• Trial end date: 2020-04-15
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Huoshenshan Hospital
• Collaborator: Ascletis Pharmaceuticals Co., Ltd.
• Treatments: Lactams; Ritonavir

Criteria

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.).