Beta-glucans for Hospitalised Patients With COVID-19
- Conditions
- COVID-19
- Interventions
- Drug: PlaceboDrug: MC 3x3
- Registration Number
- NCT05465798
- Lead Sponsor
- Wohlstand Pharmaceutical
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 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. Beta-Glucans MC 3x3 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.
- Primary Outcome Measures
Name Time Method Symptom duration Up to 2 weeks after randomisation or hospital discharge Total time with disease manifestations attributable to COVID-19.
Clinical recovery Seven days after randomisation or up to hospital discharge Number of patients without clinical complaints attributable to COVID-19
Symptom severity WURSS-21 scores calculated 7 days after randomisation Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.
- Secondary Outcome Measures
Name Time Method Invasive mechanical ventilation Up to seven days after randomisation Proportion of patients requiring invasive mechanical ventilation in each study group
C-Reactive protein levels This laboratory exam will be measured on days 1, 3, 5 and 7 after randomisation. C-Reactive protein levels measured at various time intervals during the hospitalisation.
Hospital Stay Until hospital discharge Total stay within the hospital amongst participants
Neutrophil to lymphocyte ratio This laboratory exam will be measured on days 1, 3, 5 and 7 after randomisation. Neutrophil to lymphocyte ratios measured at various time intervals during the hospitalisation.
Survival Up to seven days after randomisation Proportion of patients that survived COVID-19 in each study group
Absolute lymphocyte count This laboratory exam will be measured on days 1, 3, 5 and 7 after randomisation. Absolute lymphocyte counts measured at various time intervals during the hospitalisation.
Intensive Care Unit Admission Up to seven days after randomisation Proportion of patients requiring admission to an intensive care unit in each study group
Trial Locations
- Locations (1)
Hospital Gustavo Fricke
🇨🇱Viña Del Mar, Valparaiso, Chile