Evaluation of Ganovo （Danoprevir ） Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection
- Conditions
- COVID-19
- Interventions
- Drug: Ganovo+ritonavir+/-Interferon nebulization
- Registration Number
- NCT04291729
- Lead Sponsor
- The Ninth Hospital of Nanchang
- Brief Summary
Evaluation of the efficacy and safety of Ganovo combined with ritonavir for patients infected with SARS-CoV-2.
- Detailed Description
Given no specific antiviral therapies for new coronavirus pneumonia approved yet and Ganovo, an oral Hepatitis C virus protease inhibitor, approved in China in June 2018 , this open, controlled trial will evaluate the efficacy and safety of Ganovo in hospitalized patients infected with SARS-CoV-2.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
- 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.
- 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.).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ganovo+ritonavir with or without interferon nebulization Ganovo+ritonavir+/-Interferon nebulization -
- Primary Outcome Measures
Name Time Method Rate of composite adverse outcomes 14 days Defined as SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤300mmHg or a respiratory rate ≥30 breaths per min without supplemental oxygen
- Secondary Outcome Measures
Name Time Method Rate of no fever 14 days Rate of no fever
Rate of mechanical ventilation 14 days Rate of mechanical ventilation
Rate of ICU admission 14 days Rate of ICU admission
Rate of no cough 14 days Rate of no cough
Time to recovery 14 days 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 ≥ 24 breaths per min without supplemental oxygen).
Rate of no dyspnea 14 days Rate of no dyspnea
Rate of no requiring supplemental oxygen 14 days Rate of no requiring supplemental oxygen
Rate of undetectable New coronavirus pathogen nucleic acid 14 days Rate of undetectable New coronavirus pathogen nucleic acid
Rate of serious adverse event 14 days Rate of serious adverse event
Trial Locations
- Locations (1)
The Ninth Hospital of Nanchang
🇨🇳Nanchang, Jiangxi, China