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. 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. Forty RT-PCR positive COVID-19 patients were divided into 2 groups: control (n=22) receiving standard treatment; and treatment (n=18) receiving standard treatment plus combination of AFO-202 and N-163 beta glucans for 15 days. IL-6 levels significantly decreased in the treatment group on day 7 (p=0.03). 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). 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). These results indicate that co-supplementation with AFO-202 and N-163 beta-glucans led to improvement in CRP, ferritin, and IL-6 levels in COVID-19 patients, with only the reduction in IL-6 levels on day 7 reaching statistical significance.
This 2025 randomised clinical trial investigated whether combining two variants of Aureobasidium pullulans-produced beta-1,3-1,6-glucans — AFO-202 and N-163 strains — could reduce critical inflammatory markers in hospitalised COVID-19 patients. Elevated biomarkers including IL-6, CRP, ferritin, and D-dimer are established predictors of disease severity and respiratory failure in COVID-19.
Forty RT-PCR-positive COVID-19 patients were divided into a control group (n=22) receiving standard treatment and a treatment group (n=18) receiving standard treatment plus the combination of both beta-glucan variants for 15 days. Published in Global Advances in Integrative Medicine and Health (2025).
The treatment group showed significantly more efficient control of IL-6, CRP, and ferritin levels compared to the control group receiving standard care alone. The combination of AFO-202 and N-163 beta-glucan strains demonstrated additive immunomodulatory effects, helping to dampen the cytokine storm that characterises severe COVID-19 disease.
This randomised clinical trial provides evidence that Aureobasidium pullulans-derived beta-glucan can serve as a safe adjunct to standard COVID-19 treatment protocols. The ability to control inflammatory biomarkers may help reduce disease progression and the risk of respiratory failure in hospitalised patients, supporting the therapeutic potential of beta-1,3-1,6-glucan supplementation in viral infection management.
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Pushkala, Subramanian; Seshayyan, Sudha; Theranirajan, Ethirajan; Sudhakar, Doraisamy; Raghavan, Kadalraja; Dedeepiya, Vidyasagar Devaprasad; Ikewaki, Nobunao; Iwasaki, Masaru; Preethy, Senthilkumar; Abraham, Samuel Jk. 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. Global Advances in Integrative Medicine and Health. 2025. DOI: 10.1177/27536130251327134. PMID: 40092217.
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