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Completed

NCT Number: NCT04951336

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

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.

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Key information

Conditions

COVID-19 Vaccination

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

San Diego, California, 92093, United States

About this study

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 and immune response in 45 total subjects.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FoTv

Dietary Supplement

Fomitopsis Officinalis and Trametes Versicolor

Primary outcomes

  1. AST Normal to Abnormal Transition

    Time frame: 14 days

    The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that transitioned to abnormal at Day 14 relative to all participants with normal values at baseline.

  2. ALT Normal to Abnormal Transition

    Time frame: 14 days

    The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

  3. ALP Normal to Abnormal Transition

    Time frame: 14 days

    The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

  4. eGFR Normal to Abnormal Transition

    Time frame: 14 days

    The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

Secondary outcomes

  1. SARS-CoV-2 Receptor Binding Domain (RBD)

    Time frame: Single-dose vaccine (J&J): days 1, 14, and 28, and 6-months post-vaccination; two-dose vaccine (Pfizer or Moderna): days 1, 14, and 42 (two weeks after second dose), and 6-months post-vaccination; and vaccine booster: days 1, 3, and 14, and 6-months.

    higher scores indicate higher levels of RBD levels

  2. SARS-CoV-2 Spike Protein ("Spike").

    Time frame: Single-dose vaccine (J&J): days 1, 14, and 28, and 6-months post-vaccination; two-dose vaccine (Pfizer or Moderna): days 1, 14, and 42 (two weeks after second dose), and 6-months post-vaccination; and vaccine booster: days 1, 3, and 14, and 6-months.

    higher scores indicate higher levels of Spike levels

  3. Side-Effect Number

    Time frame: Days, 1, 2, 3, 4, 5

    count of the number of CDC side effects associated with vaccine. higher scores indicate higher number of endorsed side effects. Count of: feeling feverish, low fever in the afternoon, alternating fever and chills, chills, fatigue, muscle aches, nausea, headaches, redness/swelling at injection site, and pain at injection site. The range was from zero to 10.

  4. Side-Effect Severity

    Time frame: Days, 1, 2, 3, 4, 5

    Sum of the side effect severities for the CDC side effects associated with vaccine. higher scores indicate higher severity. The side effects included: feeling feverish, low fever in the afternoon, alternating fever and chills, chills, fatigue, muscle aches, nausea, headaches, redness/swelling at injection site, and pain at injection site. The scale for each side effect ranged from zero to 4. The total possible scale was zero to 40.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Multicenter Double-Blind, Placebo-Controlled RCT of Fomitopsis Officinalis/Trametes Versicolor for COVID-19

Acronym: MACH19

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 6, 2021
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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