First clinical study using HCV protease inhibitor danoprevir to treat COVID-19 patients
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Abstract
Introduction:
As coronavirus disease 2019 (COVID-19) outbreak globally, repurposing approved drugs is emerging as important therapeutic options. Danoprevir boosted by ritonavir (Ganovo) is a potent hepatitis C virus (HCV) protease (NS3/4A) inhibitor, which was approved and marketed in China since 2018 to treat chronic hepatitis C patients.
Methods:
This is an open-label, single arm study evaluating the effects of danoprevir boosted by ritonavir on treatment naïve and experienced COVID-19 patients for the first time. Patients received danoprevir boosted by ritonavir (100 mg/100 mg, twice per day). The primary endpoint was the rate of composite adverse outcomes and efficacy was also evaluated.
Results:
The data showed that danoprevir boosted by ritonavir is safe and well tolerated in all patients. No patient had composite adverse outcomes during this study. After initiation of danoprevir/ritonavir treatment, the first negative reverse real-time PCR (RT-PCR) test occurred at a median of 2 days, ranging from 1 to 8 days, and the obvious absorption in CT scans occurred at a median 3 days, ranging from 2 to 4 days. After 4 to 12-day treatment of danoprevir boosted by ritonavir, all enrolled 11 patients were discharged from the hospital.
Conclusion:
Our findings suggest that repurposing danoprevir for COVID-19 is a promising therapeutic option.
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SciScore for 10.1101/2020.03.22.20034041: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: All patients signed informed consent form.
IRB: The Ethics Committee of the hospital approved the study.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable Inclusion Criteria: Chinese adult (18-75 years old in both genders) pneumonia patients with SARS-COV-2 infection confirmed to be positive by RT-PCR; demonstrated respiratory symptoms and imaging-confirmed pneumonia as defined in China National Standards; naïve patients were newly diagnosed patients who never received any antiviral treatments and danoprevir/ritonavir treatment were initiated within 7 days or less from the diagnosis; experienced … SciScore for 10.1101/2020.03.22.20034041: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: All patients signed informed consent form.
IRB: The Ethics Committee of the hospital approved the study.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable Inclusion Criteria: Chinese adult (18-75 years old in both genders) pneumonia patients with SARS-COV-2 infection confirmed to be positive by RT-PCR; demonstrated respiratory symptoms and imaging-confirmed pneumonia as defined in China National Standards; naïve patients were newly diagnosed patients who never received any antiviral treatments and danoprevir/ritonavir treatment were initiated within 7 days or less from the diagnosis; experienced patients might receive antiviral therapies with dosage and treatment duration recommended by China National Standards [14]; women and their partners with no planned pregnancy for 6 months after the study and willing to take effective contraceptive measures within 30 days from the first administration of the study drugs; patients agreed that they would not participate in other clinical trials within 30 days from the last administration of the study drugs; patients were willing to sign informed consent form. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04291729 Completed Evaluation of Ganovo （Danoprevir ） Combined With Ritonavir i… Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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