Beneficial effects of novel aureobasidium pullulans strains produced beta-1,3-1,6 glucans on interleukin-6 and D-dimer levels in COVID-19 patients; results of a randomized multiple-arm pilot clinical study

Biomed Pharmacother. 2022 Jan;145:112243. doi: 10.1016/j.biopha.2021.112243. Epub 2021 Sep 25.

Abstract

Objective: In this pilot clinical study, we report the beneficial effects of beta glucans derived from two strains AFO-202 and N-163 of a black yeast Aureobasidium pullulans on the biomarkers for cytokine storm and coagulopathy in COVID-19 patients.

Methods: A total of 24 RT-PCR positive COVID-19 patients were recruited and randomly divided into three groups (Gr): Gr. 1 control (n = 8) - Standard treatment; Gr. 2: Standard treatment + AFO-202 beta glucan (n = 8); and Gr. 3, Standard treatment + combination of AFO-202 and N-163 beta glucans (n = 8) for 30 days.

Results: There was no mortality or requirement of ventilation of the subjects in any of the groups. There was a decrease in D-Dimer values (751 ng/ml to 143.89 ng/ml) and IL-6 values (7.395-3.16 pg/ml) in Gr. 1 in 15 days but the levels increased to abnormal levels on day 30 (D-Dimer: 202.5 ng/ml; IL-6 55.37 pg/ml); which steadily decreased up to day 30 in groups 2 (D-dimer: 560.99 ng/dl to 79.615; IL-6: 26.18-3.41 pg/ml) and 3 (D-dimer: 1614 ng/dl to 164.25 ng/dl; IL-6: 6.25-0.5 pg/ml). The same trend was observed with ESR. LCR and LeCR increased while NLR decreased significantly in Gr. 3. CD4 + and CD8 + T cell count showed relatively higher increase in Gr.3. There was no difference in CRP within the groups.

Conclusion: As these beta glucans are well known food supplements with a track record for safety, larger multi-centric clinical studies are recommended to validate their use as an adjunct in the management of COVID-19 and the ensuing long COVID-19 syndrome.

Keywords: Adjunct treatment; Beta glucans; COVID-19; Coagulopathy; Cytokine storm; D-dimer; IL-6; Immuno-modulation.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aureobasidium*
  • Biomarkers / blood
  • COVID-19 Drug Treatment*
  • COVID-19* / blood
  • COVID-19* / diagnosis
  • Complementary Therapies / methods
  • Cytokine Release Syndrome* / blood
  • Cytokine Release Syndrome* / etiology
  • Cytokine Release Syndrome* / prevention & control
  • Dietary Supplements
  • Female
  • Fibrin Fibrinogen Degradation Products / analysis*
  • Humans
  • Immunologic Factors / administration & dosage
  • Interleukin-6 / analysis*
  • Male
  • Middle Aged
  • Pilot Projects
  • SARS-CoV-2
  • Treatment Outcome
  • beta-Glucans / administration & dosage*

Substances

  • Biomarkers
  • Fibrin Fibrinogen Degradation Products
  • Immunologic Factors
  • Interleukin-6
  • beta-Glucans
  • fibrin fragment D

Supplementary concepts

  • Aureobasidium pullulans