Evidence map›Paper›PMID 34840031›Full record

Trial reportBiomedicine & pharmacotherapy = Biomedecine & pharmacotherapie2022

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.

Kadalraja Raghavan, Vidyasagar Devaprasad Dedeepiya, Vaddi Suryaprakash, Kosagi-Sharaf Rao, Nobunao Ikewaki, Tohru Sonoda, Gary A Levy, Masaru Iwasaki, Rajappa Senthilkumar, Senthilkumar Preethy and 1 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
6.0field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 38 citations in OpenAlex.

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  17. Efficacy of N-163 beta-glucan in beneficially improving biomarkers of relevance to muscle function in patients with muscular dystrophies in a pilot clinical study.Acta myologica : myopathies and cardiomyopathies : official journal of the Mediterranean Society of Myology · 2023
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  19. Re-examination of therapeutic management of muscular dystrophies using a vascular smooth muscle-centered approach.Journal of smooth muscle research = Nihon Heikatsukin Gakkai kikanshi · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 4 countries.

Kadalraja RaghavanDept 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.
Vidyasagar Devaprasad DedeepiyaMary-Yoshio Translational Hexagon (MYTH), Nichi-In Centre for Regenerative Medicine (NCRM), Chennai, India. Electronic address: dedeepiya_76@yahoo.co.in.
Vaddi SuryaprakashDepartment of Urology, Yashoda Hospitals, Hyderabad, India. Electronic address: suryaprakashuro@gmail.com.
Kosagi-Sharaf RaoInstituto de Investigaciones Científicas y Servicios de Alta Tecnología (INDICASAT AIP), City of Knowledge, Panama. Electronic address: jrao@indicasat.org.pa.
Nobunao IkewakiDept. 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.
Tohru SonodaInstitute of Immunology, Junsei Educational Institute, Nobeoka, Miyazaki, Japan. Electronic address: sonodat@phoenix.ac.jp.
Gary A LevyProfessor Emeritus, Medicine and Immunology, University of Toronto, Ontario, Canada. Electronic address: gary.levy@uhn.ca.
Masaru IwasakiCentre for Advancing Clinical Research (CACR), University of Yamanashi - School of Medicine, Chuo, Japan. Electronic address: miwasaki@yamanashi.ac.jp.
Rajappa SenthilkumarFujio-Eiji Academic Terrain (FEAT), Nichi-In Centre for Regenerative Medicine (NCRM), Chennai, India. Electronic address: rsk@nichimail.jp.
Senthilkumar PreethyFujio-Eiji Academic Terrain (FEAT), Nichi-In Centre for Regenerative Medicine (NCRM), Chennai, India. Electronic address: drspp@nichimail.jp.
Samuel Jk AbrahamMary-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.
Institute for Stem Cell Biology and Regenerative Medicine · INUniversity of Yamanashi · JPCity of Knowledge · PAKyushu University of Health and Welfare · JPUniversity of Toronto · CAYashoda Hospital · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveIn 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.

methodsA 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.

resultsThere 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.

conclusionAs 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.

Indexed as

AureobasidiumCOVID-19COVID-19 Drug TreatmentCytokine Release Syndromebeta-GlucansBiomarkersComplementary TherapiesDietary SupplementsFemaleFibrin Fibrinogen Degradation ProductsHumansImmunologic FactorsInterleukin-6MaleMiddle AgedPilot Projectsbeta-GlucansBiomarkersFibrin Fibrinogen Degradation Productsfibrin fragment DImmunologic FactorsInterleukin-6Adjunct treatmentBeta glucansCoagulopathyCOVID-19Cytokine stormD-dimerIL-6Immuno-modulation

Identifiers

PMID34840031
PMCPMC8463314
OpenAlexW3202878329

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.