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, Sudha Seshayyan, Ethirajan Theranirajan, Doraisamy Sudhakar, Kadalraja Raghavan, Vidyasagar Devaprasad Dedeepiya, Nobunao Ikewaki, Masaru Iwasaki, Senthilkumar Preethy, Samuel Jk Abraham
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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.
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