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

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

Detailed Description
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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.

Official Title
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An Open Clinical Trial to Evaluate Danoprevir Sodium Tablets Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Danoprevir+Ritonavir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Danoprevir+Ritonavir group<br> | Drug: Danoprevir+Ritonavir<br>* 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.<br>* Other names: Ganovo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of composite adverse outcomes | Defined as SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤ 300mmHg or a respiratory rate ≥30 breaths per min without supplemental oxygen min without supplemental oxygen | Within 10 days after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recovery | Clinical recovery was defined as sustained (48 hours) alleviation of illness based on symptom scores (fever, cough, diarrhea, myalgia, dyspnea) all being absent and no evidence for progression (newly-presented dyspnea, SpO2 decline ≥3%, respiratory rate ≥ 30 breaths per min without supplemental oxygen). | Within 10 days after administration | 
| Rate of no fever |  | Within 10 days after administration | 
| Rate of no cough |  | Within 10 days after administration | 
| Rate of no dyspnea |  | Within 10 days after administration | 
| Rate of no requiring supplemental oxygen |  | Within 10 days after administration | 
| Rate of undetectable New coronavirus pathogen nucleic acid |  | Within 10 days after administration | 
| Rate of mechanical ventilation |  | Within 10 days after administration | 
| Rate of ICU admission |  | Within 10 days after administration | 
| Rate of serious adverse event |  | Within 10 days after administration |