Beta-glucans for Hospitalised Patients With COVID-19

NCT05465798 | Unknown Phase 2

• 1 other identifier: CON-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Keywords

beta-Glucans; Therapy; Signs and Symptoms; Mechanical ventilation; Inflammation; Survival

Outcome Measures

Primary Outcomes (7)

• Symptom severity

  Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.

  WURSS-21 scores calculated 1 day after randomisation

• Symptom severity

  Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.

  WURSS-21 scores calculated 2 days after randomisation

• Symptom severity

  Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.

  WURSS-21 scores calculated 3 days after randomisation

• Symptom severity

  Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.

  WURSS-21 scores calculated 5 days after randomisation

• Symptom severity

  Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.

  WURSS-21 scores calculated 7 days after randomisation

• Symptom duration

  Total time with disease manifestations attributable to COVID-19.

  Up to 2 weeks after randomisation or hospital discharge

• Clinical recovery

  Number of patients without clinical complaints attributable to COVID-19

  Seven days after randomisation or up to hospital discharge

Secondary Outcomes (7)

• C-Reactive protein levels

  This laboratory exam will be measured on days 1, 3, 5 and 7 after randomisation.

• Absolute lymphocyte count

  This laboratory exam will be measured on days 1, 3, 5 and 7 after randomisation.

• Neutrophil to lymphocyte ratio

  This laboratory exam will be measured on days 1, 3, 5 and 7 after randomisation.

• Intensive Care Unit Admission

  Up to seven days after randomisation

• Invasive mechanical ventilation

  Up to seven days after randomisation

Other Outcomes (1)

• Adverse events

  Up to seven days after randomisation

Study Arms (2)

Beta-Glucans

EXPERIMENTAL

Patients allocated to this arm will receive MC 3x3, an oral supplement containing 25mg of 1,3 beta-Glucans daily for up to three consecutive days.

Drug: MC 3x3

Placebo

PLACEBO COMPARATOR

Participants allocated to this arm will receive a placebo that will be identical in form to the MC 3x3 pills used the interventional arm. These doses will be scheduled daily and administered orally for up to three consecutive days.

Drug: Placebo

Interventions

MC 3x3 DRUG

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.

Beta-Glucans

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wohlstand Pharmaceutical: lead
• Concentra Educación e Investigación Biomédica: collaborator

Study Sites (1)

Hospital Gustavo Fricke

Viña del Mar, Región de Valparaíso, 2570017, Chile

Location

Related Publications (8)

• 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.

  PMID: 32109013 BACKGROUND

• 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.

  PMID: 32325252 BACKGROUND

• 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.

  PMID: 32161940 BACKGROUND

• 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.

  PMID: 32223047 BACKGROUND

• 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.

  PMID: 9705343 BACKGROUND

• 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.

  PMID: 16849475 BACKGROUND

• 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.

  PMID: 30380356 BACKGROUND

• 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.

  PMID: 24149590 BACKGROUND

MeSH Terms

Conditions

COVID-19; Signs and Symptoms; Inflammation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Alejandra Correa, MD

  Hospital Geriátrico Paz de La Tarde

  STUDY DIRECTOR

• Maria José Ruz

  Hospital Gustavo Fricke

  PRINCIPAL INVESTIGATOR

• Mario Reyes

  Science & Cash Group SpA

  PRINCIPAL INVESTIGATOR

• Felipe Martinez, MD, MSc

  Concentra Investigacion

  PRINCIPAL INVESTIGATOR

• Michael Araya

  Hospital Gustavo Fricke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Araya

CONTACT

989996955; michaelarayach@gmail.com

Felipe T Martinez, MD, MSc

CONTACT

2573399; felipe.martinez@concentrainvestigacion.cl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible participants will be randomised to receive either beta-glucan supplements or placebo for up to three days.

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 20, 2022
• Study Start: June 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 13, 2022

Record last verified: 2022-12

Locations

CL (1)