Evaluation of the efficacy and safety of Ganovo combined with ritonavir for patients infected with SARS-CoV-2.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Ganovo one tablet (100mg / tablet) at a time, twice a day, up to 14 days. Ritonavir one tablet(100mg / tablet) at a time, twice a day, up to 14 days.With or without spray inhalation of interferon, 50μg / time for adults, twice a day up to 14 days.
The Ninth Hospital of Nanchang
Nanchang, Jiangxi, 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
Time frame: 14 days
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 ≥ 24 breaths per min without supplemental oxygen).
Time frame: 14 days
Rate of no fever
Rate of no fever
Time frame: 14 days
Rate of no cough
Rate of no cough
Time frame: 14 days
Rate of no dyspnea
Rate of no dyspnea
Time frame: 14 days
Rate of no requiring supplemental oxygen
Rate of no requiring supplemental oxygen
Time frame: 14 days
Rate of undetectable New coronavirus pathogen nucleic acid
Rate of undetectable New coronavirus pathogen nucleic acid
Time frame: 14 days
Rate of mechanical ventilation
Rate of mechanical ventilation
Time frame: 14 days
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Rate of ICU admission
Rate of ICU admission
Time frame: 14 days
Rate of serious adverse event
Rate of serious adverse event
Time frame: 14 days