We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

RCT of Mushroom Based Natural Product to Enhance Immune Response to COVID-19 Vaccination (MACH19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04951336
Recruitment Status : Active, not recruiting
First Posted : July 6, 2021
Last Update Posted : November 2, 2022
Sponsor:
Information provided by (Responsible Party):
Gordon Saxe, University of California, San Diego

Brief Summary:
This is a randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of two polypore mushrooms, Fomitopsis officinalis and Trametes versicolor (FoTv), for use as an adjunct to vaccination for COVID-19 in a general population at the time of COVID-19 vaccination.

Condition or disease Intervention/treatment Phase
COVID-19 Vaccination Dietary Supplement: FoTv Not Applicable

Detailed Description:

This is a randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of two polypore mushrooms, Fomitopsis officinalis and Trametes versicolor (FoTv), for use as an adjunct to vaccination for COVID-19 in a general population at the time of COVID-19 vaccination.

Fo and Tv have immunomodulatory properties which may increase antibody titers in response to vaccination more than vaccination alone. However, because they are also immunomodulatory - not purely immune-stimulating - they may have the added benefit of simultaneously decreasing vaccine-related side effects following COVID-19 vaccination.

The study aims to establish the safety and feasibility of the use of FoTv vs placebo; evaluate the effect on post-vaccination clinical symptoms, neutralizing antibody, and immune response in 45 total subjects

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Mix model involving two groups and multiple measurements across study time-points
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Multicenter Double-Blind, Placebo-Controlled RCT of Fomitopsis Officinalis/Trametes Versicolor for COVID-19
Actual Study Start Date : June 10, 2021
Actual Primary Completion Date : May 15, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mushrooms
Drug: FoTv The dosage of FoTv is 8 capsules three times a day for 4 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary. Should swallowing capsules be an issue, they can be opened and dispensed into water or juice for easy ingestion.
Dietary Supplement: FoTv
Fomitopsis Officinalis and Trametes Versicolor

Placebo Comparator: Placebo
Placebo: organic brown rice The dosage of Placebo is 8 capsules three times a day for 4 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary. Should swallowing capsules be an issue, they can be opened and dispensed into water or juice for easy ingestion.
Dietary Supplement: FoTv
Fomitopsis Officinalis and Trametes Versicolor




Primary Outcome Measures :
  1. Creatinine concentration [ Time Frame: 15 days ]
    The safety of the study medication will be assessed by a comparison of the serum creatinine level of baseline laboratory data with end-of-treatment labs

  2. Aspartate transaminase concentration [ Time Frame: 15 days ]
    The safety of the study medication will be assessed by a comparison of the serum AST level of baseline laboratory data with end-of-treatment labs

  3. Alanine transaminase concentration [ Time Frame: 15 days ]
    The safety of the study medication will be assessed by a comparison of the serum ALT level of baseline laboratory data with end-of-treatment labs

  4. Albumine concentration [ Time Frame: 15 days ]
    The safety of the study medication will be assessed by a comparison of the serum albumine level of baseline laboratory data with end-of-treatment labs

  5. Bilirubin concentration [ Time Frame: 15 days ]
    The safety of the study medication will be assessed by a comparison of the serum bilirubin level of baseline laboratory data with end-of-treatment labs

  6. Electrolyte balance [ Time Frame: 15 days ]
    The safety of the study medication will be assessed by a comparison of the serum electrolyte levels of baseline laboratory data with end-of-treatment labs

  7. SARS-CoV-2 Antibody titer [ Time Frame: 180 days ]
    The effect of study medication will be assessed by a comparison of the plasma antibody titer among subjects in active arm compared with placebo

  8. Duration (number of days) of post-vaccination symptoms [ Time Frame: 4 days ]
    Objective will be to evaluate post-vaccination symptoms duration (number of days) among subjects in the active arm compared with placebo

  9. Severity scores of post-vaccination symptoms [ Time Frame: 4 days ]
    Objective will be to evaluate post-vaccination symptoms severity total score among subjects in the active arm compared with placebo


Secondary Outcome Measures :
  1. Peripheral Blood Mononuclear Cell (PBMC) immune profiling [ Time Frame: 180 days ]
    Exploratory objective will be to evaluate immune response to COVID-19 vaccination in the presence of FoTv compared to placebo arm



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Scheduled for or planning on scheduling COVID-19 vaccination
  • Age 18 years and older
  • Willing to avoid alcohol, cannabis, and dairy products during the study product in-take period.
  • Capable of documenting vitals, symptoms, and study product intake daily and communicating this information to the study team

Exclusion Criteria:

  • Known liver disease (or diagnosis of cirrhosis)
  • Known renal disease or acute nephritis.
  • Pregnant or breastfeeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04951336


Locations
Layout table for location information
United States, California
University of California, San Diego
San Diego, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Investigators
Layout table for investigator information
Principal Investigator: Andrew Shubov, MD University of California, Los Angeles
Layout table for additonal information
Responsible Party: Gordon Saxe, Director, Krupp Center for Integrative Research, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04951336    
Other Study ID Numbers: 200633-1c
First Posted: July 6, 2021    Key Record Dates
Last Update Posted: November 2, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases