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

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

Detailed 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.

Unknown status
COVID-19

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.

Drug: 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.

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Chile
Locations

Hospital Gustavo Fricke
Viña Del Mar, Valparaiso, Chile

Investigator: Michael Araya
michaelarayach@gmail.com

Contacts

Michael Araya
989996955 - + 56 9
michaelarayach@gmail.com

Felipe T Martinez, MD, MSc
2573399 - +56 32
felipe.martinez@concentrainvestigacion.cl

Concentra Educación e Investigación Biomédica
NCT Number
Keywords
beta-Glucans
Therapy
Signs and Symptoms
Mechanical Ventilation
inflammation
Survival
MeSH Terms
COVID-19