Beta-glucans for Hospitalised Patients With COVID-19

COVID-19 Clinical Trial

Official title:

Beta-glucans as Immune Modulators Amongst Hospitalised Patients With COVID-19: A Pilot Randomised Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05465798
• Other study ID #: CON-001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2022
• Source: Wohlstand Pharmaceutical
• Contact: Michael Araya
• Phone: 989996955
• Email: michaelarayach[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomised trial aims to assess the role of beta1-3 glucan supplementation in improving clinical symptoms and other outcomes amongst hospitalised patients with COVID-19.

Description:

COVID-19 can present as a life-threatening disease characterised by respiratory failure and high circulating levels of inflammatory cytokines. Beta-glucans comprise a heterogeneous group of natural polysaccharides consisting of D-glucose monomers linked by a beta-glycosidic bond. They represent key structural elements of the cell wall and may serve as energy storage in bacteria, fungi including yeast, algae, and plants. In this triple-masked randomised trial, hospitalised patients requiring treatment with supplemental oxygen because of a laboratory-confirmed infection by SARS-CoV-2 will receive supplementation with 1-3 beta-glucans or placebo as part of their standard treatment. The primary endpoint of this trial is the intensity of clinical symptoms as detected by the Wisconsin Upper Respiratory Symptom Survey (WURSS).

Patients requiring mechanical ventilation at baseline will be excluded, as will those with cognitive impairment that precludes the use of clinical assessment scales, patients in which an order to limit therapeutic efforts has been issued, pregnant or breastfeeding women and those who decline to participate in this study. Secondary outcomes will include clinical deterioration requiring admission to an intensive care unit, requirement of high-flow nasal cannula or invasive mechanical ventilation and overall survival. Patients will be followed-up until hospital discharge or up to fifteen days after randomisation. Statistical analyses will be undertaken by a statistician unaware of treatment allocation under the intention-to-treat principle.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult participants with an infection caused by SARS-CoV-2 confirmed with a reverse-transcription polymerase chain reaction (RT-PCR) obtained from a nasopharyngeal swab.

Exclusion Criteria:

• Life expectancy < 6 months

• Currently receiving invasive mechanical ventilation at baseline.

• Cognitive impairment that precludes the use of WURSS or understanding the informed consent form.

• Refusal to participate.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• MC 3x3
Patients allocated to this arm will receive MC 3x3, an oral supplement containing 25mg of 1,3 beta-Glucans of fungal origin (Trichoderma sp.) daily for up to three consecutive days.
• Placebo
Patients allocated to this arm will receive a matching placebo similar to MC 3x3 pills used in the intervention arm. Placebos will be delivered orally every day for up to three consecutive days.

Locations

Country	Name	City	State
Chile	Hospital Gustavo Fricke	Viña Del Mar	Valparaiso

Sponsors (2)

Lead Sponsor	Collaborator
Wohlstand Pharmaceutical	Concentra Educación e Investigación Biomédica

Country where clinical trial is conducted

Chile, 

References & Publications (8)

De Marco Castro E, Calder PC, Roche HM. beta-1,3/1,6-Glucans and Immunity: State of the Art and Future Directions. Mol Nutr Food Res. 2021 Jan;65(1):e1901071. doi: 10.1002/mnfr.201901071. Epub 2020 Apr 27. — View Citation

Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28. — View Citation

Li B, Allendorf DJ, Hansen R, Marroquin J, Ding C, Cramer DE, Yan J. Yeast beta-glucan amplifies phagocyte killing of iC3b-opsonized tumor cells via complement receptor 3-Syk-phosphatidylinositol 3-kinase pathway. J Immunol. 2006 Aug 1;177(3):1661-9. doi: 10.4049/jimmunol.177.3.1661. — View Citation

Mah E, Kaden VN, Kelley KM, Liska DJ. Beverage Containing Dispersible Yeast beta-Glucan Decreases Cold/Flu Symptomatic Days After Intense Exercise: A Randomized Controlled Trial. J Diet Suppl. 2020;17(2):200-210. doi: 10.1080/19390211.2018.1495676. Epub 2018 Oct 31. — View Citation

Qin C, Zhou L, Hu Z, Zhang S, Yang S, Tao Y, Xie C, Ma K, Shang K, Wang W, Tian DS. Dysregulation of Immune Response in Patients With Coronavirus 2019 (COVID-19) in Wuhan, China. Clin Infect Dis. 2020 Jul 28;71(15):762-768. doi: 10.1093/cid/ciaa248. — View Citation

Talbott S, Talbott J. Effect of BETA 1, 3/1, 6 GLUCAN on Upper Respiratory Tract Infection Symptoms and Mood State in Marathon Athletes. J Sports Sci Med. 2009 Dec 1;8(4):509-15. eCollection 2009. — View Citation

Yuki K, Fujiogi M, Koutsogiannaki S. COVID-19 pathophysiology: A review. Clin Immunol. 2020 Jun;215:108427. doi: 10.1016/j.clim.2020.108427. Epub 2020 Apr 20. — View Citation

Zimmerman JW, Lindermuth J, Fish PA, Palace GP, Stevenson TT, DeMong DE. A novel carbohydrate-glycosphingolipid interaction between a beta-(1-3)-glucan immunomodulator, PGG-glucan, and lactosylceramide of human leukocytes. J Biol Chem. 1998 Aug 21;273(34):22014-20. doi: 10.1074/jbc.273.34.22014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Adverse events attributable to Beta-Glucan supplementation	Up to seven days after randomisation
Primary	Symptom severity	Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.	WURSS-21 scores calculated 1 day after randomisation
Primary	Symptom severity	Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.	WURSS-21 scores calculated 2 days after randomisation
Primary	Symptom severity	Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.	WURSS-21 scores calculated 3 days after randomisation
Primary	Symptom severity	Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.	WURSS-21 scores calculated 5 days after randomisation
Primary	Symptom severity	Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.	WURSS-21 scores calculated 7 days after randomisation
Primary	Symptom duration	Total time with disease manifestations attributable to COVID-19.	Up to 2 weeks after randomisation or hospital discharge
Primary	Clinical recovery	Number of patients without clinical complaints attributable to COVID-19	Seven days after randomisation or up to hospital discharge
Secondary	C-Reactive protein levels	C-Reactive protein levels measured at various time intervals during the hospitalisation.	This laboratory exam will be measured on days 1, 3, 5 and 7 after randomisation.
Secondary	Absolute lymphocyte count	Absolute lymphocyte counts measured at various time intervals during the hospitalisation.	This laboratory exam will be measured on days 1, 3, 5 and 7 after randomisation.
Secondary	Neutrophil to lymphocyte ratio	Neutrophil to lymphocyte ratios measured at various time intervals during the hospitalisation.	This laboratory exam will be measured on days 1, 3, 5 and 7 after randomisation.
Secondary	Intensive Care Unit Admission	Proportion of patients requiring admission to an intensive care unit in each study group	Up to seven days after randomisation
Secondary	Invasive mechanical ventilation	Proportion of patients requiring invasive mechanical ventilation in each study group	Up to seven days after randomisation
Secondary	Survival	Proportion of patients that survived COVID-19 in each study group	Up to seven days after randomisation
Secondary	Hospital Stay	Total stay within the hospital amongst participants	Until hospital discharge