The Ninth Hospital of Nanchang
Nanchang, Jiangxi, 330000, China
NCT Number: NCT04291729
Evaluation of the efficacy and safety of Ganovo combined with ritonavir for patients infected with SARS-CoV-2.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 4
Nanchang, Jiangxi, 330000, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 14 days
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
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
Time frame: 14 days
Rate of no cough
Time frame: 14 days
Rate of no dyspnea
Time frame: 14 days
Rate of no requiring supplemental oxygen
Time frame: 14 days
Rate of undetectable New coronavirus pathogen nucleic acid
Time frame: 14 days
Rate of mechanical ventilation
Time frame: 14 days
Rate of ICU admission
Time frame: 14 days
Rate of serious adverse event
The Ninth Hospital of Nanchang
Other
An Open Clinical Trial to Evaluate Ganovo(Danoprevir ) Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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