Beta-glucans for Hospitalised Patients With COVID-19

December 9, 2022 updated by: Wohlstand Pharmaceutical

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Chile
    • Valparaiso
      • Viña Del Mar, Valparaiso, Chile, 2570017
        • Hospital Gustavo Fricke
        • Contact:
        • Contact:
        • Principal Investigator:
          • Roberto A Merino, MD
        • Principal Investigator:
          • Nicolas M Caroca, MD
        • Sub-Investigator:
          • Alejandra V Fernández, RN
        • Sub-Investigator:
          • Cristian Ortega, PharmD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Beta-Glucans
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.
Drug: MC 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.
Placebo Comparator: 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.
Drug: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Symptom severity
Time Frame: WURSS-21 scores calculated 1 day after randomisation
Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.
WURSS-21 scores calculated 1 day after randomisation
Symptom severity
Time Frame: WURSS-21 scores calculated 2 days after randomisation
Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.
WURSS-21 scores calculated 2 days after randomisation
Symptom severity
Time Frame: WURSS-21 scores calculated 3 days after randomisation
Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.
WURSS-21 scores calculated 3 days after randomisation
Symptom severity
Time Frame: WURSS-21 scores calculated 5 days after randomisation
Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.
WURSS-21 scores calculated 5 days after randomisation
Symptom severity
Time Frame: WURSS-21 scores calculated 7 days after randomisation
Symptom severity based on the Wisconsin Upper Respiratory Symptom Survey (WURSS) score.
WURSS-21 scores calculated 7 days after randomisation
Symptom duration
Time Frame: Up to 2 weeks after randomisation or hospital discharge
Total time with disease manifestations attributable to COVID-19.
Up to 2 weeks after randomisation or hospital discharge
Clinical recovery
Time Frame: Seven days after randomisation or up to hospital discharge
Number of patients without clinical complaints attributable to COVID-19
Seven days after randomisation or up to hospital discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
C-Reactive protein levels
Time Frame: 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.
This laboratory exam will be measured on days 1, 3, 5 and 7 after randomisation.
Absolute lymphocyte count
Time Frame: 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.
This laboratory exam will be measured on days 1, 3, 5 and 7 after randomisation.
Neutrophil to lymphocyte ratio
Time Frame: 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.
This laboratory exam will be measured on days 1, 3, 5 and 7 after randomisation.
Intensive Care Unit Admission
Time Frame: Up to seven days after randomisation
Proportion of patients requiring admission to an intensive care unit in each study group
Up to seven days after randomisation
Invasive mechanical ventilation
Time Frame: Up to seven days after randomisation
Proportion of patients requiring invasive mechanical ventilation in each study group
Up to seven days after randomisation
Survival
Time Frame: Up to seven days after randomisation
Proportion of patients that survived COVID-19 in each study group
Up to seven days after randomisation
Hospital Stay
Time Frame: Until hospital discharge
Total stay within the hospital amongst participants
Until hospital discharge

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Up to seven days after randomisation
Adverse events attributable to Beta-Glucan supplementation
Up to seven days after randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wohlstand Pharmaceutical

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Concentra Educación e Investigación Biomédica

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Alejandra Correa, MD, Hospital Geriátrico Paz de La Tarde
  • Principal Investigator: Maria José Ruz, Hospital Gustavo Fricke
  • Principal Investigator: Mario Reyes, Science & Cash Group SpA
  • Principal Investigator: Felipe Martinez, MD, MSc, Concentra Investigacion
  • Principal Investigator: Michael Araya, Hospital Gustavo Fricke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CON-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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