Beneficial effects of novel aureobasidium pullulans strains produced beta-1,3-1,6 glucans on interleukin-6 and D-dimer levels in COVID-19 patients; results of a randomized multiple-arm pilot clinical study
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SciScore for 10.1101/2021.08.09.21261738: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable Severe COVID-19-affected patients requiring intensive care, children and pregnant women were excluded. Randomization The present study was an open label, prospective, randomized, comparative, multiple arm pilot clinical study to evaluate the immune enhancement and immunomodulatory efficacy of supplementation with A. pullulans’ novel strains produced beta glucans compared to those who undergo a conventional therapeutic regimen alone in adult subjects with COVID-19 caused by SARS-CoV2(B-CoV). Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Data were analysed using Microsoft Excel and Origin 2021b … SciScore for 10.1101/2021.08.09.21261738: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable Severe COVID-19-affected patients requiring intensive care, children and pregnant women were excluded. Randomization The present study was an open label, prospective, randomized, comparative, multiple arm pilot clinical study to evaluate the immune enhancement and immunomodulatory efficacy of supplementation with A. pullulans’ novel strains produced beta glucans compared to those who undergo a conventional therapeutic regimen alone in adult subjects with COVID-19 caused by SARS-CoV2(B-CoV). Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Data were analysed using Microsoft Excel and Origin 2021b statistical software. Microsoft Excelsuggested: (Microsoft Excel, RRID:SCR_016137)Originsuggested: (Origin, RRID:SCR_014212)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:The limitations of the study include the large number of drop-outs that have been attributed to the psychosocial factors of visiting the hospital for follow-up. In addition, the sample number was less, but this is only a pilot clinical study. We conducted this study at the time of a decline in the second wave in India [29] when infection due to the delta variant of SARS-CoV2 virus was gradually emerging as a threat [30] with increased contagiousness [31]. We have not studied genomic sequencing in the subjects to identify the delta variant virus, and this needs further evaluation to study the efficacy of the beta glucans against emerging variants. The significance of beta glucan groups versus control though is evident in this study, the difference in the quantum of beneficial effects between the AFO-202 (Gr.2 ) and that of Gr. 3 due to smaller sample numbers is not very clear, as reported in the earlier clinical study in terms of immunomodulation in healthy volunteers [14] and anti-inflammatory, anti-fibrotic effects in NASH animal models [13], warrant a larger study to confirm the same. In such larger multi-centric clinical trials, evaluations on other biochemical and immunological parameters along with radiological diagnostics can help decipher the various underlying mechanisms to further validate the advantageous effects of these safety-proven beta-glucans so that they could be recommended for continued supplemental prophylaxis as a vaccine adjuvant [8] and as an adjunct to...
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.
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- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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