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 clinical trial

BackgroundSeveral 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. ObjectiveIn 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. MethodsA 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. ResultsThe 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). ConclusionThese 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.