COVID-19 VaccinationMACH19NCT04951336

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

A study testing FoTv in people with COVID-19 Vaccination, run by University of California, San Diego at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19 Vaccination
What is being tested?: FoTv
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 1 siteUnited States
Study dates: 10 Jun 2021to 6 Jul 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California, San Diego
San Diego, California, 92093

Other trials in United States

About this study

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

Read the detailed description

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.

Conditions: COVID-19 Vaccination
Being tested: FoTv

What participants receive

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

FoTvDietary supplement
Fomitopsis Officinalis and Trametes Versicolor

Study groups in NCT04951336
Study group	Role	What they receive
Mushrooms	Experimental	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. Receives: Dietary Supplement: FoTv
Placebo	Placebo comparator	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. Receives: Dietary Supplement: FoTv

What is being measured

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

AST Normal to Abnormal Transition
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.
Measured: 14 days
ALT Normal to Abnormal Transition
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.
Measured: 14 days
ALP Normal to Abnormal Transition
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.
Measured: 14 days
eGFR Normal to Abnormal Transition
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.
Measured: 14 days

Secondary outcomes (4)

SARS-CoV-2 Receptor Binding Domain (RBD)
higher scores indicate higher levels of RBD levels
Measured: 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.
SARS-CoV-2 Spike Protein ("Spike").
higher scores indicate higher levels of Spike levels
Measured: 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.
Side-Effect Number
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.
Measured: Days, 1, 2, 3, 4, 5
Side-Effect Severity
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.
Measured: Days, 1, 2, 3, 4, 5

Timeline

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

10 Jun 20216 Jul 2022

First posted6 Jul 2021
Study start10 Jun 2021
Primary completion21 Jan 2022
Study completion6 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COVID-19 VaccinationStudies of the same condition, open and under way.
More trials run by University of California, San DiegoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: Mix model involving two groups and multiple measurements across study time-points
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04951336
Sponsor's protocol ID: 200633-1c
Acronym: MACH19
Status last verified: Aug 2025
First submitted: 30 Jun 2021
Last updated: 17 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Saxe G, Smith CN, Golshan S, Shekhtman T, Bair ZJ, Beathard C, Davis RA, MacElhern L, Shubov A, Slater D, Kao LK, Senowitz P, Wilson S. Polypore mushroom mycelia as an adjunct to COVID-19 vaccination: a randomized clinical trial. BMC Immunol. 2026 Jan 31;27(1):24. doi: 10.1186/s12865-026-00809-9.
PubMed 41620671

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter Double-Blind, Placebo-Controlled RCT of Fomitopsis Officinalis/Trametes Versicolor for COVID-19
ClinicalTrials.gov ID: NCT04951336
Acronym / sponsor ID: MACH19 / 200633-1c
Conditions: COVID-19 Vaccination
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: University of California, San DiegoUniversity, hospital or other
Study start: 10 Jun 2021 (actual)
Primary completion: 21 Jan 2022 (actual)
Study completion: 6 Jul 2022 (actual)
First posted: 6 Jul 2021 (actual)
Results: Posted 17 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: Mix model involving two groups and multiple measurements across study time-points

Arm	Type	Receives
Mushrooms	Experimental	Dietary Supplement: FoTvDrug: 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.
Placebo	Placebo comparator	Dietary Supplement: FoTvPlacebo: 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FoTvFomitopsis Officinalis and Trametes Versicolor	Dietary supplement	Mushrooms, Placebo

Primary outcome

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.
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.
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.
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.

4 secondary outcomes

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.
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.
Side-Effect Number
Time frame: Days, 1, 2, 3, 4, 5
Side-Effect Severity
Time frame: Days, 1, 2, 3, 4, 5

Results and safety

Results posted to the registry on 17 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mushrooms	52	51
Placebo	38	38

Primary outcome: AST Normal to Abnormal Transition

Time frame: 14 days. Number. Unit: % of participants who transitioned

Measure	Mushrooms n = 50	Placebo n = 38
Value	2.0	2.6

Mushrooms vs Placebo: ratio of frequencies: 0.04, p = 1.000, Chi-squared, Corrected

Population analysed: Number of participants who were normal at baseline. Participants who were abnormal at baseline were excluded, therefore the number of participants in this analysis is different from the total number of participants in the Mushrooms or Placebo groups described in the study arms/groups.

Primary outcome: ALT Normal to Abnormal Transition

Time frame: 14 days. Number. Unit: % of participants who transitioned

Measure	Mushrooms n = 43	Placebo n = 34
Value	4.7	5.9

Mushrooms vs Placebo: ratio of frequencies: 0.06, p = 1.000, Chi-squared, Corrected

Population analysed: Number of participants who were normal at baseline. Participants who were abnormal at baseline were excluded.

Primary outcome: ALP Normal to Abnormal Transition

Time frame: 14 days. Number. Unit: % of participants who transitioned

Measure	Mushrooms n = 52	Placebo n = 36
Value	1.9	0

Mushrooms vs Placebo: ratio of frequencies: 0.70, p = 1.000, Chi-squared, Corrected

Primary outcome: eGFR Normal to Abnormal Transition

Time frame: 14 days. Number. Unit: % of participants who transitioned

Measure	Mushrooms n = 38	Placebo n = 35
Value	10.5	2.9

Mushrooms vs Placebo: ratio of frequencies: 1.68, p = 0.359, Chi-squared, Corrected

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 14 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mushrooms	0 of 52 (0%)	8 of 52 (15.4%)	0 of 52
Placebo	0 of 38 (0%)	4 of 38 (10.5%)	0 of 38

Limitations and caveats (from the sponsor): Because of the rapidly changing nature of the COVID-19 pandemic, we didn't have sufficient time to ascertain, and stratify randomization based on, exposure status. Earlier launch might also have resulted in a larger proportion of Unexposed participants in the total sample. A 4-day treatment regimen was selected. Alternate dosing regimens at time of and immediately post-vaccination might have yielded different effects on Ab and other outcomes. we didn't examine Ab levels beyond 6-months.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41620671Saxe G, Smith CN, Golshan S, Shekhtman T, Bair ZJ, Beathard C, Davis RA, MacElhern L, Shubov A, Slater D, Kao LK, Senowitz P, Wilson S. Polypore mushroom mycelia as an adjunct to COVID-19 vaccination: a randomized clinical trial. BMC Immunol. 2026 Jan 31;27(1):24. doi: 10.1186/s12865-026-00809-9.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrew Shubov, MD principal investigator

University of California, Los Angeles

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FoTv in people with COVID-19 Vaccination, run by University of California, San Diego at 1 site in United States.

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 4 inclusion and 3 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: finished, as of the sponsor's last update on 17 Aug 2025. 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 United States. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AST Normal to Abnormal Transition (time frame: 14 days). The study lists 4 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 NCT04951336, which also lists 1 linked publication.

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 17 Aug 2025.