AVIFAVIR for Treatment of Patients With Moderate Coronavirus Disease 2019 (COVID-19): Interim Results of a Phase II/III Multicenter Randomized Clinical Trial
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Abstract
In May 2020 the Russian Ministry of Health granted fast-track marketing authorization to RNA polymerase inhibitor AVIFAVIR (favipiravir) for the treatment of COVID-19 patients. In the pilot stage of Phase II/III clinical trial, AVIFAVIR enabled SARS-CoV-2 viral clearance in 62.5% of patients within 4 days, and was safe and well-tolerated.
Clinical Trials Registration. NCT04434248.
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SciScore for 10.1101/2020.07.26.20154724: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: The eligible patients included hospitalized men and non-pregnant women of 18 years or older who signed the informed consent form, had moderate PCR-confirmed COVID-19 (positive test at screening), were able to administrate the drug orally and willing to use adequate contraception during the study and 3 months after its completion. Randomization This was an adaptive, multicenter, open label, randomized, Phase II/III clinical trial of AVIFAVIR versus standard of care (SOC) in hospitalized patients with moderate COVID-19 pneumonia. Blinding not detected. Power Analysis The “go-no-go” decision to start the pivotal stage of the study was based on the exact … SciScore for 10.1101/2020.07.26.20154724: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: The eligible patients included hospitalized men and non-pregnant women of 18 years or older who signed the informed consent form, had moderate PCR-confirmed COVID-19 (positive test at screening), were able to administrate the drug orally and willing to use adequate contraception during the study and 3 months after its completion. Randomization This was an adaptive, multicenter, open label, randomized, Phase II/III clinical trial of AVIFAVIR versus standard of care (SOC) in hospitalized patients with moderate COVID-19 pneumonia. Blinding not detected. Power Analysis The “go-no-go” decision to start the pivotal stage of the study was based on the exact single-stage Phase II assessment at one-sided α=0.05 and 80% power [8]. Sex as a biological variable The eligible patients included hospitalized men and non-pregnant women of 18 years or older who signed the informed consent form, had moderate PCR-confirmed COVID-19 (positive test at screening), were able to administrate the drug orally and willing to use adequate contraception during the study and 3 months after its completion. 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 NCT04434248 Active, not recruiting An Adaptive Study of Favipiravir Compared to Standard of Car… 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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SciScore for 10.1101/2020.07.26.20154724: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement The eligible patients included hospitalized men and non-pregnant women of 18 years or older who signed the informed consent form, had moderate PCR-confirmed COVID-19 (positiv test at screening), were able to administrate the drug orally and willing to use adequate contraception during the study and 3 months after its completion. Randomization The patients were randomized at a 1:1:1 ratio to receive either AVIFAVIR 1600 mg BID on Day 1 followed by 600 mg BID on Days 2-14 (1600/600 mg), or AVIFAVIR 1800 mg BID on Day 1 followed by 800 mg BID on Days 2-14 (1800/800 mg), or SOC according to the Russian guidelines for treatment of COVID-19 [7]. Blinding not detected. Powe… SciScore for 10.1101/2020.07.26.20154724: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement The eligible patients included hospitalized men and non-pregnant women of 18 years or older who signed the informed consent form, had moderate PCR-confirmed COVID-19 (positiv test at screening), were able to administrate the drug orally and willing to use adequate contraception during the study and 3 months after its completion. Randomization The patients were randomized at a 1:1:1 ratio to receive either AVIFAVIR 1600 mg BID on Day 1 followed by 600 mg BID on Days 2-14 (1600/600 mg), or AVIFAVIR 1800 mg BID on Day 1 followed by 800 mg BID on Days 2-14 (1800/800 mg), or SOC according to the Russian guidelines for treatment of COVID-19 [7]. Blinding not detected. Power Analysis not detected. Sex as a biological variable The eligible patients included hospitalized men and non-pregnant women of 18 years or older who signed the informed consent form, had moderate PCR-confirmed COVID-19 (positiv test at screening), were able to administrate the drug orally and willing to use adequate contraception during the study and 3 months after its completion. 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 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.
About SciScore
SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.
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