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COVID-19Phase 2NCT05465798

Beta-glucans for Hospitalised Patients With COVID-19

A Phase 2 study testing MC 3x3 in people with COVID-19, run by Wohlstand Pharmaceutical at 1 site in Chile.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
MC 3x3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteChile
Study dates
Jun 2023to Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Michael Araya contact

989996955 ext. + 56 9

michaelarayach@gmail.com

Felipe T Martinez, MD, MSc contact

2573399 ext. +56 32

felipe.martinez@concentrainvestigacion.cl

Chile1 site

  • Hospital Gustavo Fricke

    Viña del Mar, Valparaiso, 2570017

    Michael Araya, michaelarayach@gmail.com

    Alejandra Correa, MD, acorreall@gmail.com

Other trials in Chile

About this study

Official title: Beta-glucans as Immune Modulators Amongst Hospitalised Patients With COVID-19: A Pilot Randomised Trial

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.

Read the 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.

Conditions
COVID-19
Being tested
MC 3x3, Placebo
Keywords
beta-Glucans, Therapy, Signs and Symptoms, Mechanical ventilation, Inflammation, Survival
Medical subject headings
COVID-19, Signs and Symptoms, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MC 3x3Drug

    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.

  • PlaceboDrug

    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.

Study groups in NCT05465798
Study groupRoleWhat they receive
Beta-GlucansExperimentalPatients 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.
Receives: Drug: MC 3x3
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptom severity

    Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.

    Measured: WURSS-21 scores calculated 1 day after randomisation

  2. Symptom severity

    Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.

    Measured: WURSS-21 scores calculated 2 days after randomisation

  3. Symptom severity

    Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.

    Measured: WURSS-21 scores calculated 3 days after randomisation

  4. Symptom severity

    Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.

    Measured: WURSS-21 scores calculated 5 days after randomisation

  5. Symptom severity

    Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.

    Measured: WURSS-21 scores calculated 7 days after randomisation

  6. Symptom duration

    Total time with disease manifestations attributable to COVID-19.

    Measured: Up to 2 weeks after randomisation or hospital discharge

  7. Clinical recovery

    Number of patients without clinical complaints attributable to COVID-19

    Measured: Seven days after randomisation or up to hospital discharge

Secondary outcomes (7)

  1. C-Reactive protein levels

    C-Reactive protein levels measured at various time intervals during the hospitalisation.

    Measured: This laboratory exam will be measured on days 1, 3, 5 and 7 after randomisation.

  2. Absolute lymphocyte count

    Absolute lymphocyte counts measured at various time intervals during the hospitalisation.

    Measured: This laboratory exam will be measured on days 1, 3, 5 and 7 after randomisation.

  3. Neutrophil to lymphocyte ratio

    Neutrophil to lymphocyte ratios measured at various time intervals during the hospitalisation.

    Measured: This laboratory exam will be measured on days 1, 3, 5 and 7 after randomisation.

  4. Intensive Care Unit Admission

    Proportion of patients requiring admission to an intensive care unit in each study group

    Measured: Up to seven days after randomisation

  5. Invasive mechanical ventilation

    Proportion of patients requiring invasive mechanical ventilation in each study group

    Measured: Up to seven days after randomisation

  6. Survival

    Proportion of patients that survived COVID-19 in each study group

    Measured: Up to seven days after randomisation

  7. Hospital Stay

    Total stay within the hospital amongst participants

    Measured: Until hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2022
  2. Study startJun 2023 (estimated)
  3. Primary completionOct 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible participants will be randomised to receive either beta-glucan supplements or placebo for up to three days.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05465798
Sponsor's protocol ID
CON-001
Status last verified
Dec 2022
First submitted
15 Jul 2022
Last updated
13 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32109013

  • 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.

    PubMed 32325252

  • 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.

    PubMed 32161940

  • 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.

    PubMed 32223047

  • 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.

    PubMed 9705343

  • 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.

    PubMed 16849475

  • 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.

    PubMed 30380356

  • 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.

    PubMed 24149590

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MC 3x3 in people with COVID-19, run by Wohlstand Pharmaceutical at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Michael Araya (989996955 ext. + 56 9, michaelarayach@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom severity (time frame: WURSS-21 scores calculated 1 day after randomisation). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05465798, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022.

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