Clinical Outcomes and Plasma Concentrations of Baloxavir Marboxil and Favipiravir in COVID-19 Patients: An Exploratory Randomized, Controlled Trial
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Abstract
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SciScore for 10.1101/2020.04.29.20085761: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Participants confirmed as COVID-19 infection were randomly allocated (1:1:1) to the study after approval by the ethics committees.
Consent: The trial treatment scheme started as soon as consent was obtained (Day 1).Randomization Study Design: This trial was an exploratory single center, open-label, randomized, controlled trial to evaluate the efficacy and safety of adding baloxavir marboxil or favipiravir to the current standard antiviral treatment in patients confirmed as COVID-19 who are still positive for the SARS-CoV-2 (ChiCTR2000029544). Blinding The blind method is not suitable for this trial. Power Analysis not detected. Sex as a biological variable not … SciScore for 10.1101/2020.04.29.20085761: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Participants confirmed as COVID-19 infection were randomly allocated (1:1:1) to the study after approval by the ethics committees.
Consent: The trial treatment scheme started as soon as consent was obtained (Day 1).Randomization Study Design: This trial was an exploratory single center, open-label, randomized, controlled trial to evaluate the efficacy and safety of adding baloxavir marboxil or favipiravir to the current standard antiviral treatment in patients confirmed as COVID-19 who are still positive for the SARS-CoV-2 (ChiCTR2000029544). Blinding The blind method is not suitable for this trial. Power Analysis not detected. Sex as a biological variable not detected. 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: We detected the following sentences addressing limitations in the study:There are some limitations to the current study. Firstly, the subjects were all under treatment with other medication. The treatment scheme and medication time before the initiation of the trial were different among the patients, which makes their progression of the disease at the beginning of the trial quite different. There was therefore a risk of influencing the results and conclusions. During a rapidly evolving COVID-19 situation, it was difficult to obtain large number of newly detected cases without previous treatment. Second, patients in favipiravir group showed oldest average age and shortest time from symptom onset to randomization, even though, the clinical performance of favipiravir group was not inferior to the other two groups. However, we are not sure if the efficacy of favipiravir under current dosage is underestimated because its drug exposure does not reach the EC50 value. Third, the relatively small sample size of our study poses an additional limitation. Nevertheless, it was conclusive that the free plasma concentrations of these antiviral drugs did not reach their respective EC50 values, which can be almost certainly that the drugs have no effect against SARS-CoV-2 at the dose as mentioned above. Our research cannot be simply regarded as negative results, as it is very meaningful for clinical treatment of COVID-19 in global outbreak. In addition, our exploratory research provides useful information for further studies to find the best strategy for applicat...
Results from TrialIdentifier: No clinical trial numbers were referenced.
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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