Efficient Control of IL-6, CRP and Ferritin in COVID-19 Patients With Two Variants of Beta-1,3-1,6 Glucans in Combination: An Open-Label, Prospective, Randomised Clinical Trial

DOI record: { "DOI": "10.1177/27536130251327134", "ISSN": [ "2753-6130", "2753-6130" ], "URL": "http://dx.doi.org/10.1177/27536130251327134", "abstract": "<jats:sec>\n <jats:title>Background</jats:title>\n <jats:p>Several biomarkers, including C-reactive protein (CRP), ferritin, D-dimer, and Interleukin-6 (IL-6), are established predictors of disease severity and respiratory failure in patients with COVID-19.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Objective</jats:title>\n <jats:p>\n In this randomised clinical study, we evaluated the efficiency of the combination of 2 variants’ AFO-202 and N-163 strains of\n <jats:italic>Aureobasidium pullulans</jats:italic>\n produced 1,3-1,6 β-glucans in comparison with the control arm on these biomarkers in COVID-19 patients.\n </jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Methods</jats:title>\n <jats:p>Forty RT-PCR positive COVID-19 patients were divided into 2 groups: control (n = 22) and standard treatment; ii. (n = 18) – Standard treatment + combination of AFO-202 and N-163 beta glucans for 15 days.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Results</jats:title>\n <jats:p>\n IL-6 levels significantly decreased in the treatment group on day 7 (\n <jats:italic>P</jats:italic>\n = 0.03) but not by day 15 (\n <jats:italic>P</jats:italic>\n = 0.30). CRP levels in the treatment group decreased at day 7 (5.53 ± 8.21 mg/L) compared to baseline but showed no significant difference from the control group (4.91 ± 12.54 mg/L,\n <jats:italic>P</jats:italic>\n = 0.98). At day 15, CRP levels remained lower in the treatment group (5.42 ± 10.41 mg/L) but increased in the control group (14.0 ± 37.16 mg/L), with no significant difference (\n <jats:italic>P</jats:italic>\n = 0.52). Ferritin levels dropped significantly in the treatment group by day 15 (from 560.58 ± 537.30 ng/mL to 127.51 ± 215.91 ng/mL) but increased in the control (\n <jats:italic>P</jats:italic>\n = 0.98). D-dimer levels decreased in the treatment group by day 15 but were not significantly different from controls (\n <jats:italic>P</jats:italic>\n = 0.56).\n </jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Conclusion</jats:title>\n <jats:p>These results indicate that while co-supplementation with AFO-202 and N-163 beta-glucans led to improvement in CRP, ferritin, and IL-6 levels in COVID-19 patients, only the reduction in IL-6 levels on day 7 reached statistical significance. Further long-term multicentric clinical research is warranted to validate the potential of these supplements as treatment adjuncts, for addressing inflammation in COVID-19, especially in vulnerable populations infected with emerging SARS-CoV-2 variants.</jats:p>\n </jats:sec>", "alternative-id": [ "10.1177/27536130251327134" ], "author": [ { "affiliation": [ { "name": "Department of Immunology, The Tamil Nadu Dr. M.G.R. Medical University, Chennai, India" } ], "family": "Pushkala", "given": "Subramanian", "sequence": "first" }, { "affiliation": [ { "name": "Department of Immunology, The Tamil Nadu Dr. M.G.R. Medical University, Chennai, India" } ], "family": "Seshayyan", "given": "Sudha", "sequence": "additional" }, { "affiliation": [ { "name": "Rajiv Gandhi Government General Hospital, Madras Medical College, Chennai, India" } ], "family": "Theranirajan", "given": "Ethirajan", "sequence": "additional" }, { "affiliation": [ { "name": "Rajiv Gandhi Government General Hospital, Madras Medical College, Chennai, India" } ], "family": "Sudhakar", "given": "Doraisamy", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Paediatric Neurology, Jesuit Antonyraj Memorial Inter-disciplinary Centre for Advanced Recovery and Education (JAICARE), Madurai, India" } ], "family": "Raghavan", "given": "Kadalraja", "sequence": "additional" }, { "affiliation": [ { "name": "Mary-Yoshio Translational Hexagon (MYTH), Nichi-In Centre for Regenerative Medicine (NCRM), Chennai, India" } ], "family": "Dedeepiya", "given": "Vidyasagar Devaprasad", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Medical Life Science, Kyushu University of Health and Welfare, Japan" }, { "name": "Institute of Immunology, Junsei Educational Institute, Nobeoka, Japan" } ], "family": "Ikewaki", "given": "Nobunao", "sequence": "additional" }, { "affiliation": [ { "name": "Centre for Advancing Clinical Research (CACR), University of Yamanashi - School of Medicine, Chuo, Japan" } ], "family": "Iwasaki", "given": "Masaru", "sequence": "additional" }, { "affiliation": [ { "name": "Fujio-Eiji Academic Terrain (FEAT), Nichi-In Centre for Regenerative Medicine (NCRM), Chennai, India" }, { "name": "Haraguchi-Parikumar Advanced Remedies (HARP), SoulSynergy Ltd., Phoenix, Mauritius" }, { "name": "Cherian-Yoshii Translational Exemplary (CYTE), SoulSynergy Ltd., Phoenix, Mauritius" } ], "family": "Preethy", "given": "Senthilkumar", "sequence": "additional" }, { "ORCID": "https://orcid.org/0000-0003-2646-2687", "affiliation": [ { "name": "Mary-Yoshio Translational Hexagon (MYTH), Nichi-In Centre for Regenerative Medicine (NCRM), Chennai, India" }, { "name": "Centre for Advancing Clinical Research (CACR), University of Yamanashi - School of Medicine, Chuo, Japan" }, { "name": "Fujio-Eiji Academic Terrain (FEAT), Nichi-In Centre for Regenerative Medicine (NCRM), Chennai, India" }, { "name": "Haraguchi-Parikumar Advanced Remedies (HARP), SoulSynergy Ltd., Phoenix, Mauritius" }, { "name": "Cherian-Yoshii Translational Exemplary (CYTE), SoulSynergy Ltd., Phoenix, Mauritius" } ], "authenticated-orcid": false, "family": "Abraham", "given": "Samuel JK", "sequence": "additional" } ], "container-title": "Global Advances in Integrative Medicine and Health", "container-title-short": "Global Advances in Integrative Medicine and Health", "content-domain": { "crossmark-restriction": true, "domain": [ "journals.sagepub.com" ] }, "created": { "date-parts": [ [ 2025, 3, 14 ] ], "date-time": "2025-03-14T23:11:42Z", "timestamp": 1741993902000 }, "deposited": { "date-parts": [ [ 2025, 3, 14 ] ], "date-time": "2025-03-14T23:11:44Z", "timestamp": 1741993904000 }, "indexed": { "date-parts": [ [ 2025, 3, 15 ] ], "date-time": "2025-03-15T04:27:47Z", "timestamp": 1742012867562, "version": "3.38.0" }, "is-referenced-by-count": 0, "issued": { "date-parts": [ [ 2025, 1 ] ] }, "language": "en", "license": [ { "URL": "https://journals.sagepub.com/page/policies/text-and-data-mining-license", "content-version": "tdm", "delay-in-days": 0, "start": { "date-parts": [ [ 2025, 1, 1 ] ], "date-time": "2025-01-01T00:00:00Z", "timestamp": 1735689600000 } } ], "link": [ { "URL": "https://journals.sagepub.com/doi/pdf/10.1177/27536130251327134", "content-type": "application/pdf", "content-version": "vor", "intended-application": "text-mining" }, { "URL": "https://journals.sagepub.com/doi/full-xml/10.1177/27536130251327134", "content-type": "application/xml", "content-version": "vor", "intended-application": "text-mining" }, { "URL": "https://journals.sagepub.com/doi/pdf/10.1177/27536130251327134", "content-type": "unspecified", "content-version": "vor", "intended-application": "similarity-checking" } ], "member": "179", "original-title": [], "prefix": "10.1177", "published": { "date-parts": [ [ 2025, 1 ] ] }, "published-online": { "date-parts": [ [ 2025, 3, 14 ] ] }, "published-print": { "date-parts": [ [ 2025, 1 ] ] }, "publisher": "SAGE Publications", "reference": [ { "DOI": "10.1186/s12879-021-05945-8", "doi-asserted-by": "publisher", "key": "e_1_3_6_2_2" }, { "DOI": "10.1016/j.addr.2020.12.011", "doi-asserted-by": "publisher", "key": "e_1_3_6_3_2" }, { "DOI": "10.1002/mnfr.201901071", "doi-asserted-by": "publisher", "key": "e_1_3_6_4_2" }, { "DOI": "10.1155/2012/851362", "doi-asserted-by": "publisher", "key": "e_1_3_6_5_2" }, { "DOI": "10.2478/helm-2018-0021", "doi-asserted-by": "publisher", "key": "e_1_3_6_6_2" }, { "DOI": "10.3389/fimmu.2022.870632", "doi-asserted-by": "publisher", "key": "e_1_3_6_7_2" }, { "DOI": "10.1016/j.clicom.2021.11.001", "doi-asserted-by": "publisher", "key": "e_1_3_6_8_2" }, { "DOI": "10.1016/j.jceh.2022.06.008", "doi-asserted-by": "publisher", "key": "e_1_3_6_9_2" }, { "DOI": "10.1007/s40200-022-01170-5", "doi-asserted-by": "publisher", "key": "e_1_3_6_10_2" }, { "DOI": "10.1080/21645515.2021.1880210", "doi-asserted-by": "publisher", "key": "e_1_3_6_11_2" }, { "DOI": "10.1186/s12959-020-00239-6", "doi-asserted-by": "publisher", "key": "e_1_3_6_12_2" }, { "DOI": "10.1016/j.biopha.2021.112243", "doi-asserted-by": "publisher", "key": "e_1_3_6_13_2" }, { "DOI": "10.26633/RPSP.2020.72", "doi-asserted-by": "publisher", "key": "e_1_3_6_14_2" }, { "DOI": "10.1002/jcla.24881", "doi-asserted-by": "publisher", "key": "e_1_3_6_15_2" }, { "article-title": "Beta 1,3-1,6 glucans produced by two novel strains of Aureobasidium pullulans exert immune and metabolic beneficial effects in healthy middle-aged Japanese men: results of an exploratory randomized control study", "author": "Ikewaki N", "first-page": "61", "journal-title": "JAR Life", "key": "e_1_3_6_16_2", "unstructured": "Ikewaki N, Sonoda T, Kurosawa G, et al. 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