Efficient control of IL-6, CRP and Ferritin in Covid-19 patients with two variants of Beta-1,3-1,6 glucans in combination, within 15 days in an open-label prospective randomized clinical trial
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Abstract
Background
Several biomarkers, including C-reactive protein (CRP), ferritin, fibrinogen, D-dimer, and Interleukin-6 (IL-6), are established predictors of disease severity and respiratory failure in COVID-19 patients.
Objective
In this randomized clinical study, we evaluated the efficiency of the combination of two variants’ AFO-202 and N-163 strains of Aureobasidium Pullulans produced 1,3-1,6 beta glucans in comparison with the control arm on these biomarkers in COVID-19 patients.
Methods
A total of 40 RT-PCR positive Covid-19 patients divided into two groups: i. control (n=22) – Standard treatment; ii. (n =18) – Standard treatment + combination of AFO-202 and N-163 beta glucans for 15 days.
Results
The treatment group showed decrease in CRP level compared to control. At day 7, CRP reduced to 5.53 ± 8.21 mg/L in the treatment group vs. 4.91 ± 12.54 mg/L in control (p = 0.98) (95% CI: -34.40 to 35.14). By day 15, CRP continued to be decreased at 5.42 ± 10.41 mg/L in the treatment group but it increased to 14.0 ± 37.16 mg/L in control (p = 0.52) (95% CI: -37.65 to 19.40). IL-6 levels significantly decreased in the treatment group on day 7 (p = 0.03) but the difference was not significant by day 15 (p = 0.30). Ferritin levels in the treatment group decreased from 560.58 ± 537.30 ng/mL to 127.51 ± 215.91 ng/mL by day 15, while in control increased (p = 0.98). D-Dimer level decreased in the treatment group by day 15 but was not significantly different from control (p = 0.56).
Conclusion
These results suggest that 15-day co-supplementation with AFO-202 and N-163 beta-glucans effectively controlled CRP, ferritin, and IL-6 in COVID-19 patients. Further research is warranted to investigate the potential of this supplement as a treatment adjunct, especially in vulnerable populations facing emerging SARS-CoV-2 variants.
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SciScore for 10.1101/2021.12.14.21267778: (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 not detected. 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 …SciScore for 10.1101/2021.12.14.21267778: (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 not detected. 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 drop-outs that have been attributed to the psychosocial factors of visiting the hospital for follow-up. Though the effects of the beta glucans amidst the rise of variants of concern such as the Omicron need to be studied, nevertheless the advantageous effects of these safety-proven beta-glucans reported in the present study make them worth considering as the optimal supplemental treatment and prophylaxis adjuvants.
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.
Results from scite Reference Check: We found no unreliable references.
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