COVID-19
Conditions
Brief summary
Evaluation of the efficacy and safety of Danoprevir sodium tablet combined with ritonavir for SARS-CoV-2 infected patients.
Detailed description
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.
Interventions
DRUGDanoprevir+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.
Sponsors
Ascletis Pharmaceuticals Co., Ltd.
Huoshenshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of composite adverse outcomes | Within 10 days after administration | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Time to recovery | Within 10 days after administration | 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). |
| 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 | — |
| Rate of undetectable New coronavirus pathogen nucleic acid | Within 10 days after administration | — |
Countries
China
Outcome results
None listed