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. 2025 Mar 14:14:27536130251327134.
doi: 10.1177/27536130251327134. eCollection 2025 Jan-Dec.

Efficient Control of IL-6, CRP and Ferritin in COVID-19 Patients With Two Variants of Beta-1,3-1,6 Glucans in Combination: An Open-Label, Prospective, Randomised Clinical Trial

Subramanian Pushkala  1 , Sudha Seshayyan  1 , Ethirajan Theranirajan  2 , Doraisamy Sudhakar  2 , Kadalraja Raghavan  3 , Vidyasagar Devaprasad Dedeepiya  4 , Nobunao Ikewaki  5   6 , Masaru Iwasaki  7 , Senthilkumar Preethy  8   9   10 , Samuel Jk Abraham  4   7   8   9   10   11   12   13
Affiliations

Efficient Control of IL-6, CRP and Ferritin in COVID-19 Patients With Two Variants of Beta-1,3-1,6 Glucans in Combination: An Open-Label, Prospective, Randomised Clinical Trial

Subramanian Pushkala et al. Glob Adv Integr Med Health. .

Abstract

Background: Several biomarkers, including C-reactive protein (CRP), ferritin, D-dimer, and Interleukin-6 (IL-6), are established predictors of disease severity and respiratory failure in patients with COVID-19.

Objective: In this randomised clinical study, we evaluated the efficiency of the combination of 2 variants' AFO-202 and N-163 strains of Aureobasidium pullulans produced 1,3-1,6 β-glucans in comparison with the control arm on these biomarkers in COVID-19 patients.

Methods: Forty RT-PCR positive COVID-19 patients were divided into 2 groups: control (n = 22) and standard treatment; ii. (n = 18) - Standard treatment + combination of AFO-202 and N-163 beta glucans for 15 days.

Results: IL-6 levels significantly decreased in the treatment group on day 7 (P = 0.03) but not by day 15 (P = 0.30). CRP levels in the treatment group decreased at day 7 (5.53 ± 8.21 mg/L) compared to baseline but showed no significant difference from the control group (4.91 ± 12.54 mg/L, P = 0.98). At day 15, CRP levels remained lower in the treatment group (5.42 ± 10.41 mg/L) but increased in the control group (14.0 ± 37.16 mg/L), with no significant difference (P = 0.52). Ferritin levels dropped significantly in the treatment group by day 15 (from 560.58 ± 537.30 ng/mL to 127.51 ± 215.91 ng/mL) but increased in the control (P = 0.98). D-dimer levels decreased in the treatment group by day 15 but were not significantly different from controls (P = 0.56).

Conclusion: These results indicate that while co-supplementation with AFO-202 and N-163 beta-glucans led to improvement in CRP, ferritin, and IL-6 levels in COVID-19 patients, only the reduction in IL-6 levels on day 7 reached statistical significance. Further long-term multicentric clinical research is warranted to validate the potential of these supplements as treatment adjuncts, for addressing inflammation in COVID-19, especially in vulnerable populations infected with emerging SARS-CoV-2 variants.

Keywords: C-reactive protein; COVID-19; IL-6; adjunct treatment; beta glucans; cytokine storm; ferritin; immuno-modulation.

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Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Author Samuel Abraham is a shareholder in GN Corporation, Japan which in turn is a shareholder in the manufacturing company of novel beta glucans using different strains of Aureobasidium pullulans.

Figures

Figure 1.
Figure 1.
CONSORT flow diagram illustrating the enrolment, allocation, follow-up, and analysis stages of the trial.
Figure 2.
Figure 2.
CRP levels in the treatment groups compared to the control group. CRP levels showed a decrease until day 7, followed by an increase by day 15. IL-6 levels in the treatment groups compared to the control group, showing a consistent decrease over time. Ferritin levels in the treatment groups compared to the control group. Levels decreased until day 7 and increased by day 15. D-Dimer levels in the treatment groups compared to the control group. Similar to CRP and ferritin, D-Dimer levels decreased until day 7 and increased by day 15. For each parameter, the difference in values from baseline to day 7 and day 15 is shown in separate graphs, with median values represented by plot lines within floating bars. (*Not significant; **p < 0.05 indicates statistical significance).
See this image and copyright information in PMC

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