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

<jats:title>Abstract</jats:title><jats:sec><jats:title>Objective</jats:title><jats:p>In this study, we evaluated the efficiency of the combination of two variants’ AFO-202 and N-163 strains of Aureobasidium Pullulans produced in comparison with the control arm, which underwent a conventional regimen of treatment alone, for a shorter duration of 15 days.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>A total of 40 RT-PCR positive Covid-19 patients divided into two groups (Gr): Gr. 1 control (n=22) – Standard treatment; Gr. 2 (n =18) – Standard treatment + combination of AFO-202 and N-163 beta glucans for 15 days. Biomarkers of relevance to cytokine storm and coagulopathy were evaluated at baseline on Day 7 and Day 15.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>The C-reactive protein (CRP), which declined from 33.95 mg/l to 5.07 mg/l in control and from 33.95 mg/l to 5.64 mg/l in the treatment arm on Day 7, increased to 14.6 mg/l in the former while it continued to be under control in the treatment arm at 5.68 mg/l on Day 15. The same trend was observed in Ferritin, whose values were 560.58 ng/ml at baseline to 261.44 ng/ml (day-7) and 182.40 ng/ml (day-15) in the treatment group, while it was 535.24 ng/ml at baseline, 116.66 ng/ml on day 7 and 291.95 ng/ml on day 15 in the control group. IL-6 showed a higher decrease in treatment group compared to the control group. The difference between day 7 and day 15 values were statically significant.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>A statistically significant control of IL-6, CRP and Ferritin in Covid-19 patients who orally consumed AFO-202 and N-163 strains of Aureobasidium Pullulans produced Beta glucans together in 15 days make us recommend this safe food supplement be consumed by Covid-19 patients along with conventional treatments, especially to the vulnerable population, as a prophylaxis amidst the prolonged pandemic with evolution of mutated strains of SARS-COV2.</jats:p></jats:sec>