Repurposing Treatment of Wernicke–Korsakoff Syndrome for Th-17 Cell Immune Storm Syndrome and Neurological Symptoms in COVID-19: Thiamine Efficacy and Safety, In-Vitro Evidence and Pharmacokinetic Profile

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1. Version published to 10.3389/fphar.2020.598128

   Mar 2, 2021
2. 

   ScreenIT

   Mar 1, 2021

   SciScore for 10.1101/2020.08.23.20177501: (What is this?)

   Please note, not all rigor criteria are appropriate for all manuscripts.

   Table 1: Rigor

   Institutional Review Board Statement	IRB: The studies were approved by the NIH Institutional Review Board (IRB) committee and the UofL IRB (IRB # 12.0427).
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.
   Sex as a biological variable	Sixteen age- and sex- matched male and female alcohol use disorder (AUD)
   Cell Line Authentication	not detected.

   Table 2: Resources

   Experimental Models: Cell Lines
   Sentences	Resources
   Post-hoc one-sided t-tests were performed for the IL-17 and IL-22 mRNA expression analyses for the RAW 264.7 cells testing (Figure 2).	RAW 264.7 suggested: CLS Cat# 400319/p462_RAW-2647, RRID:CVCL_0493)
   Software and Algorithms
   Sentences	Resources
   Laboratory Assays and …

   SciScore for 10.1101/2020.08.23.20177501: (What is this?)

   Please note, not all rigor criteria are appropriate for all manuscripts.

   Table 1: Rigor

   Institutional Review Board Statement	IRB: The studies were approved by the NIH Institutional Review Board (IRB) committee and the UofL IRB (IRB # 12.0427).
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.
   Sex as a biological variable	Sixteen age- and sex- matched male and female alcohol use disorder (AUD)
   Cell Line Authentication	not detected.

   Table 2: Resources

   Experimental Models: Cell Lines
   Sentences	Resources
   Post-hoc one-sided t-tests were performed for the IL-17 and IL-22 mRNA expression analyses for the RAW 264.7 cells testing (Figure 2).	RAW 264.7 suggested: CLS Cat# 400319/p462_RAW-2647, RRID:CVCL_0493)
   Software and Algorithms
   Sentences	Resources
   Laboratory Assays and Therapeutic Model on Th17 Inflammation Axis Development of the Pharmacokinetic Model for Dose Titration of Thiamine: We used dosing guidelines for thiamine as mentioned at the Medline Plus (https://medlineplus.gov/druginfo/natural/965.html#Safety, last reviewed as of August 5, 2020), and from peer reviewed publications from PubMed (https://pubmed.ncbi.nlm.nih.gov/; [searched and collected until August 5, 2020]).	Medline Plus suggested: (Evidence-Based Health Care Search Strategies, RRID:SCR_010606) PubMed suggested: (PubMed, RRID:SCR_004846)
   We also reviewed and incorporated thiamine dose levels (lower and higher range) from other disease conditions; namely metabolic conditions33,34, septic shock35,36, viral diseases37–39 and Leigh’s disease40 (Medline Plus: Thiamine).	Medline suggested: (MEDLINE, RRID:SCR_002185)
   SPSS 26.0 (IBM Chicago, IL) and Microsoft Excel 365	SPSS suggested: (SPSS, RRID:SCR_002865) Microsoft Excel suggested: (Microsoft Excel, RRID:SCR_016137)
   5 (MS Corp, Redmond WA), statistical software R (https://www.r-project.org/), and Prism GraphPad (GraphPad Software, San Diego CA) were used for statistical analysis, data computation, and plotting the figures.	GraphPad suggested: (GraphPad Prism, RRID:SCR_002798)

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   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).

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   Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:

   Our study has several limitations. This is a small study. However, both clinical and in vitro evidence collectively support the potential of thiamine as a therapeutic agent in attenuating the Th17 proinflammatory response. We did not test the in vitro/in vivo efficacy of thiamine in the treatment of COVID-19 or its derivative stimulated Th17 proinflammatory response directly. We anticipate conducting such in vitro experiments for COVID-19 as a continuation of this project. Moreover, plasma thiamine levels have not been assessed in COVID-19. Our study did not have sufficiently large numbers of males and females; thus, identifying sex-differences was not within the scope of this study. In summary, Thiamine has been approved by the Food and Drug Administration (FDA) of the USA as a prescription product and is considered very safe even at higher doses since it is water soluble and can be excreted via urine, if in excess68. Given its robust safety record, we suggest that thiamine should be considered for COVID-19 treatment studies.

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   Results from TrialIdentifier: No clinical trial numbers were referenced.

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   Results from Barzooka: We found bar graphs of continuous data. We recommend replacing bar graphs with more informative graphics, as many different datasets can lead to the same bar graph. The actual data may suggest different conclusions from the summary statistics. For more information, please see Weissgerber et al (2015).

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   Results from JetFighter: We did not find any issues relating to colormaps.

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   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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3. 

   Version published to 10.1101/2020.08.23.20177501v1 on medRxiv

   Aug 25, 2020