Human Safety, Tolerability, and Pharmacokinetics of Molnupiravir, a Novel Broad-Spectrum Oral Antiviral Agent with Activity against SARS-CoV-2
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Abstract
Molnupiravir (EIDD-2801/MK-4482), the prodrug of the active antiviral ribonucleoside analog β- d -N4-hydroxycytidine (NHC; EIDD-1931), has activity against a number of RNA viruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), severe acute respiratory syndrome coronavirus (SARS-CoV), Middle East respiratory syndrome coronavirus (MERS-CoV), and seasonal and pandemic influenza viruses. Single and multiple doses of molnupiravir were evaluated in this first-in-human, phase 1, randomized, double-blind, placebo-controlled study in healthy volunteers, which included evaluation of the effect of food on pharmacokinetics.
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SciScore for 10.1101/2020.12.10.20235747: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Potential subjects were screened for inclusion in the study within 28 days prior to the first dose administration after voluntarily providing informed consent.
IRB: The study was conducted in accordance with the International Council for Harmonisation Good Clinical Practice guidelines, the ethical principles outlined in the Declaration of Helsinki, and the European Union Clinical Trial Directive (2001/20/EC) following approval by applicable regulatory authorities and receipt of a favorable opinion by an ethics committee.Randomization Study design: Eligible subjects were randomized in a 3:1 ratio to either study drug or placebo in the single- and … SciScore for 10.1101/2020.12.10.20235747: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Potential subjects were screened for inclusion in the study within 28 days prior to the first dose administration after voluntarily providing informed consent.
IRB: The study was conducted in accordance with the International Council for Harmonisation Good Clinical Practice guidelines, the ethical principles outlined in the Declaration of Helsinki, and the European Union Clinical Trial Directive (2001/20/EC) following approval by applicable regulatory authorities and receipt of a favorable opinion by an ethics committee.Randomization Study design: Eligible subjects were randomized in a 3:1 ratio to either study drug or placebo in the single- and multiple-ascending-dose parts. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Pharmacokinetic parameters were calculated using noncompartmental methods in Phoenix WinNonlin Version 8.1 Phoenix WinNonlinsuggested: NoneResults 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 NCT04392219 Completed COVID-19 First In Human Study to Evaluate Safety, Tolerabili… 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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