COVID-19
Conditions
Keywords
beta-Glucans, Therapy, Signs and Symptoms, Mechanical ventilation, Inflammation, Survival
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.
Interventions
DRUGMC 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.
DRUGPlacebo
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.
Sponsors
Concentra Educación e Investigación Biomédica
Wohlstand Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Eligible participants will be randomised to receive either beta-glucan supplements or placebo for up to three days.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 1 day after randomisation | Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score. |
| Symptom duration | Up to 2 weeks after randomisation or hospital discharge | Total time with disease manifestations attributable to COVID-19. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Intensive Care Unit Admission | Up to seven days after randomisation | Proportion of patients requiring admission to an intensive care unit in each study group |
| Survival | Up to seven days after randomisation | Proportion of patients that survived COVID-19 in each study group |
| Hospital Stay | Until hospital discharge | Total stay within the hospital amongst participants |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Up to seven days after randomisation | Adverse events attributable to Beta-Glucan supplementation |
Countries
Chile
Contacts
Primary ContactMichael Araya
Backup ContactFelipe T Martinez, MD, MSc
Outcome results
None listed