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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.

Dept of Paediatric Neurology, Kenmax Healthcare Services Pvt Ltd, Madurai, India; Research & Development Division, Sarvee Integra Pvt Ltd, Chennai, India; Mary-Yoshio Translational Hexagon (MYTH), Nichi-In Centre for Regenerative Medicine (NCRM), Chennai, India. Electronic address: drkraghavan@nichimail.jp. Mary-Yoshio Translational Hexagon (MYTH), Nichi-In Centre for Regenerative Medicine (NCRM), Chennai, India. Electronic address: dedeepiya_76@yahoo.co.in. Department of Urology, Yashoda Hospitals, Hyderabad, India. Electronic address: suryaprakashuro@gmail.com. Instituto de Investigaciones Científicas y Servicios de Alta Tecnología (INDICASAT AIP), City of Knowledge, Panama. Electronic address: jrao@indicasat.org.pa. Dept. of Medical Life Science, Kyushu University of Health and Welfare, Japan; Institute of Immunology, Junsei Educational Institute, Nobeoka, Miyazaki, Japan. Electronic address: nikewaki@phoenix.ac.jp. Institute of Immunology, Junsei Educational Institute, Nobeoka, Miyazaki, Japan. Electronic address: sonodat@phoenix.ac.jp. Professor Emeritus, Medicine and Immunology, University of Toronto, Ontario, Canada. Electronic address: gary.levy@uhn.ca. Centre for Advancing Clinical Research (CACR), University of Yamanashi - School of Medicine, Chuo, Japan. Electronic address: miwasaki@yamanashi.ac.jp. Fujio-Eiji Academic Terrain (FEAT), Nichi-In Centre for Regenerative Medicine (NCRM), Chennai, India. Electronic address: rsk@nichimail.jp. Fujio-Eiji Academic Terrain (FEAT), Nichi-In Centre for Regenerative Medicine (NCRM), Chennai, India. Electronic address: drspp@nichimail.jp. Mary-Yoshio Translational Hexagon (MYTH), Nichi-In Centre for Regenerative Medicine (NCRM), Chennai, India; Centre for Advancing Clinical Research (CACR), University of Yamanashi - School of Medicine, Chuo, Japan; Antony, Xavier Interdisciplinary Scholastics (AXIS), GN Corporation Co. Ltd., Kofu, Japan. Electronic address: drsam@nichimail.jp.

Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie. 2022;:112243
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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.

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