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| Name | Class |
|---|---|
| Concentra Educación e Investigación Biomédica | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beta-Glucans | Experimental | 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. |
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| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MC 3x3 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom severity | Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score. | WURSS-21 scores calculated 1 day after randomisation |
| Symptom severity | Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score. | WURSS-21 scores calculated 2 days after randomisation |
| Symptom severity | Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score. | WURSS-21 scores calculated 3 days after randomisation |
| Symptom severity | Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score. | WURSS-21 scores calculated 5 days after randomisation |
| Symptom severity | Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score. | WURSS-21 scores calculated 7 days after randomisation |
| Symptom duration | Total time with disease manifestations attributable to COVID-19. | Up to 2 weeks after randomisation or hospital discharge |
| Clinical recovery | Number of patients without clinical complaints attributable to COVID-19 | Seven days after randomisation or up to hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| C-Reactive protein levels | C-Reactive protein levels measured at various time intervals during the hospitalisation. | This laboratory exam will be measured on days 1, 3, 5 and 7 after randomisation. |
| Absolute lymphocyte count |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events attributable to Beta-Glucan supplementation | Up to seven days after randomisation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Araya | Contact | 989996955 | + 56 9 | michaelarayach@gmail.com |
| Felipe T Martinez, MD, MSc | Contact | 2573399 | +56 32 | felipe.martinez@concentrainvestigacion.cl |
| Name | Affiliation | Role |
|---|---|---|
| Alejandra Correa, MD | Hospital Geriátrico Paz de La Tarde | Study Director |
| Maria José Ruz | Hospital Gustavo Fricke | Principal Investigator |
| Mario Reyes |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Gustavo Fricke | Viña del Mar | Valparaiso | 2570017 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32109013 | Background | Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28. | |
| 32325252 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012816 | Signs and Symptoms |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Eligible participants will be randomised to receive either beta-glucan supplements or placebo for up to three days.
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| Placebo | Drug | 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. |
|
Absolute lymphocyte counts measured at various time intervals during the hospitalisation.
| 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. | 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 | Up to seven days after randomisation |
| Invasive mechanical ventilation | Proportion of patients requiring invasive mechanical ventilation in each study group | Up to seven days after randomisation |
| Survival | Proportion of patients that survived COVID-19 in each study group | Up to seven days after randomisation |
| Hospital Stay | Total stay within the hospital amongst participants | Until hospital discharge |
| Science & Cash Group SpA |
| Principal Investigator |
| Felipe Martinez, MD, MSc | Concentra Investigacion | Principal Investigator |
| Michael Araya | Hospital Gustavo Fricke | Principal Investigator |
| Background |
| Yuki K, Fujiogi M, Koutsogiannaki S. COVID-19 pathophysiology: A review. Clin Immunol. 2020 Jun;215:108427. doi: 10.1016/j.clim.2020.108427. Epub 2020 Apr 20. |
| 32161940 | Background | Qin C, Zhou L, Hu Z, Zhang S, Yang S, Tao Y, Xie C, Ma K, Shang K, Wang W, Tian DS. Dysregulation of Immune Response in Patients With Coronavirus 2019 (COVID-19) in Wuhan, China. Clin Infect Dis. 2020 Jul 28;71(15):762-768. doi: 10.1093/cid/ciaa248. |
| 32223047 | Background | De Marco Castro E, Calder PC, Roche HM. beta-1,3/1,6-Glucans and Immunity: State of the Art and Future Directions. Mol Nutr Food Res. 2021 Jan;65(1):e1901071. doi: 10.1002/mnfr.201901071. Epub 2020 Apr 27. |
| 9705343 | Background | Zimmerman JW, Lindermuth J, Fish PA, Palace GP, Stevenson TT, DeMong DE. A novel carbohydrate-glycosphingolipid interaction between a beta-(1-3)-glucan immunomodulator, PGG-glucan, and lactosylceramide of human leukocytes. J Biol Chem. 1998 Aug 21;273(34):22014-20. doi: 10.1074/jbc.273.34.22014. |
| 16849475 | Background | Li B, Allendorf DJ, Hansen R, Marroquin J, Ding C, Cramer DE, Yan J. Yeast beta-glucan amplifies phagocyte killing of iC3b-opsonized tumor cells via complement receptor 3-Syk-phosphatidylinositol 3-kinase pathway. J Immunol. 2006 Aug 1;177(3):1661-9. doi: 10.4049/jimmunol.177.3.1661. |
| 30380356 | Background | Mah E, Kaden VN, Kelley KM, Liska DJ. Beverage Containing Dispersible Yeast beta-Glucan Decreases Cold/Flu Symptomatic Days After Intense Exercise: A Randomized Controlled Trial. J Diet Suppl. 2020;17(2):200-210. doi: 10.1080/19390211.2018.1495676. Epub 2018 Oct 31. |
| 24149590 | Background | Talbott S, Talbott J. Effect of BETA 1, 3/1, 6 GLUCAN on Upper Respiratory Tract Infection Symptoms and Mood State in Marathon Athletes. J Sports Sci Med. 2009 Dec 1;8(4):509-15. eCollection 2009. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |