Beta-glucans for Hospitalised Patients With COVID-19

Wohlstand Pharmaceutical

Status and phase: Not yet enrolling; Phase 2

Conditions: COVID-19

Treatments: Drug: MC 3x3; Drug: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05465798

CON-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Beta-Glucans

Experimental group

Description:

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.

Treatment:

Drug: MC 3x3

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo