Evaluation of the efficacy and safety of Danoprevir sodium tablet combined with ritonavir for SARS-CoV-2 infected patients.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Huoshenshan Hostipal
Wuhan, Hubei, China
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
Time frame: Within 10 days after administration
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).
Time frame: Within 10 days after administration
Rate of no fever
Time frame: Within 10 days after administration
Rate of no cough
Time frame: Within 10 days after administration
Rate of no dyspnea
Time frame: Within 10 days after administration
Rate of no requiring supplemental oxygen
Time frame: Within 10 days after administration
Rate of undetectable New coronavirus pathogen nucleic acid
Time frame: Within 10 days after administration
Rate of mechanical ventilation
Time frame: Within 10 days after administration
Rate of ICU admission
Time frame: Within 10 days after administration
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Rate of serious adverse event
Time frame: Within 10 days after administration