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RCT 2025

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

Pushkala, Subramanian; Seshayyan, Sudha; Theranirajan, Ethirajan; Sudhakar, Doraisamy; Raghavan, Kadalraja; Dedeepiya, Vidyasagar Devaprasad; Ikewaki, Nobunao; Iwasaki, Masaru; Preethy, Senthilkumar; Abraham, Samuel Jk · Global Advances in Integrative Medicine and Health · DOI: 10.1177/27536130251327134 · PMID: 40092217
Research Archive
TL;DR — Key Findings
  • Forty COVID-19 patients received standard care with or without two AP-beta-glucans.
  • Only the day-7 IL-6 between-group result reached statistical significance.
  • The study was small, open-label, short, and not sufficient to establish clinical benefit.

Abstract

This open-label randomized study included 40 people with PCR-confirmed COVID-19. Eighteen received standard care plus AFO-202 and N-163 Aureobasidium pullulans beta-glucans for 15 days, while 22 received standard care alone. IL-6 decreased more in the supplementation group at day 7, the reported between-group result that reached statistical significance. CRP and ferritin changed over time, but the reported comparisons do not establish a consistent treatment effect across biomarkers. The small sample, open-label design, short follow-up, and biomarker-focused outcomes limit conclusions about symptoms, hospitalization, recovery, or mortality.

Summary

Summary

Study design

A small open-label randomized study compared standard care with or without two AP-beta-glucan preparations in 40 COVID-19 patients.

Interpretation

Only the day-7 IL-6 comparison reached statistical significance. Larger blinded trials with clinical outcomes are needed.

AI-generated summary for accessibility. Always refer to the original paper.

Keywords

COVID-19 SARS-CoV-2 beta glucan Aureobasidium pullulans IL-6 D-dimer cytokine storm immunomodulation clinical trial AFO-202 N-163

Citation

Pushkala, Subramanian; Seshayyan, Sudha; Theranirajan, Ethirajan; Sudhakar, Doraisamy; Raghavan, Kadalraja; Dedeepiya, Vidyasagar Devaprasad; Ikewaki, Nobunao; Iwasaki, Masaru; Preethy, Senthilkumar; Abraham, Samuel Jk. 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. Global Advances in Integrative Medicine and Health. 2025. DOI: 10.1177/27536130251327134. PMID: 40092217.

Study Details
Study Type
RCT
Published
2025
Journal
Global Advances in Integrative Medicine and Health
Authors
Pushkala, Subramanian; Seshayyan, Sudha; Theranirajan, Ethirajan; Sudhakar, Doraisamy; Raghavan, Kadalraja; Dedeepiya, Vidyasagar Devaprasad; Ikewaki, Nobunao; Iwasaki, Masaru; Preethy, Senthilkumar; Abraham, Samuel Jk
PubMed ID
40092217
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