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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
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.
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.
Hospital Gustavo Fricke
Viña del Mar, Valparaiso, Chile
Symptom severity
Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.
Time frame: WURSS-21 scores calculated 1 day after randomisation
Symptom severity
Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.
Time frame: WURSS-21 scores calculated 2 days after randomisation
Symptom severity
Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.
Time frame: WURSS-21 scores calculated 3 days after randomisation
Symptom severity
Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.
Time frame: WURSS-21 scores calculated 5 days after randomisation
Symptom severity
Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.
Time frame: WURSS-21 scores calculated 7 days after randomisation
Symptom duration
Total time with disease manifestations attributable to COVID-19.
Time frame: Up to 2 weeks after randomisation or hospital discharge
Clinical recovery
Number of patients without clinical complaints attributable to COVID-19
Time frame: Seven days after randomisation or up to hospital discharge
C-Reactive protein levels
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C-Reactive protein levels measured at various time intervals during the hospitalisation.
Time frame: This laboratory exam will be measured on days 1, 3, 5 and 7 after randomisation.
Absolute lymphocyte count
Absolute lymphocyte counts measured at various time intervals during the hospitalisation.
Time frame: This laboratory exam will be measured on days 1, 3, 5 and 7 after randomisation.
Neutrophil to lymphocyte ratio
Neutrophil to lymphocyte ratios measured at various time intervals during the hospitalisation.
Time frame: This laboratory exam will be measured on days 1, 3, 5 and 7 after randomisation.
Intensive Care Unit Admission
Proportion of patients requiring admission to an intensive care unit in each study group
Time frame: Up to seven days after randomisation
Invasive mechanical ventilation
Proportion of patients requiring invasive mechanical ventilation in each study group
Time frame: Up to seven days after randomisation
Survival
Proportion of patients that survived COVID-19 in each study group
Time frame: Up to seven days after randomisation
Hospital Stay
Total stay within the hospital amongst participants
Time frame: Until hospital discharge