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 randomized clinical trial

  1. Subramanian Pushkala
  2. Sudha Seshayyan
  3. Ethirajan Theranirajan
  4. Doraisamy Sudhakar
  5. Kadalraja Raghavan
  6. Vidyasagar Devaprasad Dedeepiya
  7. Nobunao Ikewaki
  8. Masaru Iwasaki
  9. Senthilkumar Preethy
  10. Samuel JK Abraham
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Abstract

Background

Several 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.

Objective

In 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.

Methods

A 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.

Results

The 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).

Conclusion

These 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.

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