COVID-19Phase 1/2MACH19NCT04667247

RCT of Fomitopsis Officinalis and Trametes Versicolor to Treat COVID-19

A Phase 1/2 study testing FoTv in people with COVID-19, run by Gordon Saxe at 2 sites in United States.

Completed

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

Trial summary

This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate two polypore mushrooms, Fomitopsis officinalis and Trametes versicolor (FoTv), to treat COVID-19-positive outpatients with mild-to-moderate symptoms assigned to self-quarantined and home management. 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
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: 54 participants
Where: 2 sitesUnited States
Study dates: 23 Dec 2020to 4 May 2022
Phase: Phase 1/2
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

Positive COVID-19 diagnosis within the prior 72 hours
Age 18 years and older
Women of childbearing potential must have a negative urine or serum hCG. Women of childbearing potential must have a negative serum pregnancy test at screening and agree to use contraception throughout the study period.
Capable of documenting vitals, symptoms, and study product intake daily and communicating this information to the study team
Willing to avoid alcohol, cannabis, and dairy products during the study period.

Who cannot join

Any of the following symptoms which, according to the CDC, require hospitalization:
Trouble breathing
Persistent pain or pressure in the chest
New confusion or inability to arouse
Bluish lips or face
Current use of investigational agents to prevent or treat COVID-19

Show all 10Show fewer

Known liver disease (ALT/AST >3x ULN or diagnosis of cirrhosis)
Known renal disease (eGFR < 60 ml/min) or acute nephritis.
Uncontrolled hypertension (SBP>140 or DBP>90 while on medications)
Pregnant or breastfeeding women

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of California, Los Angeles
Los Angeles, California, 90095
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 and Trametes Versicolor to Treat COVID-19

Read the detailed description

Despite biomedical advances, medical intervention for COVID-19 is largely limited to vaccinations and supportive care during the later stages of disease. While antiviral, anti-inflammatory, and antimalarial options have been explored for later stages of disease, fewer studies have been conducted on medications to reduce the risk of outpatient cases progressing to severe disease. Therefore, it is important that we broaden the search to include agents outside of our usual pharmacopeia. Integrative Medicine offers several promising therapeutics that are available today and warrant investigation.

Some of the botanicals used for their possible immune modulating functions include polypore mushrooms. Among these, Turkey Tail (Trametes versicolor) has a long history of use for its immune supporting properties. An RCT examining the effects of Trametes versicolor in breast cancer patients detected increases in lymphocyte counts and natural killer cell functional activity (Torkelson et al, 2012 and Benson et al, 2019) both of which are key to host COVID-19 response. Further investigations into other relevant mushroom species demonstrated that Agarikon (Fomitopsis officinalis) can strongly induce an array of differential cytokine responses associated with both immune-activation and resolution of host defense- induced inflammatory reactions (unpublished). This homeostatic effect deserves attention for COVID-19 given the high mortality rate associated with cytokine storm.

This is a multi-center, randomized, double blind, placebo-controlled clinical trial to evaluate two polypore mushrooms, Fomitopsis officinalis and Trametes versicolor (FoTv), to treat COVID-19-positive outpatients with mild-to-moderate symptoms assigned to self-quarantined and home management. This study aims to establish the safety and feasibility of the use of FoTv vs placebo in 66 total subjects. Subsequent trials will evaluate Chinese herbal medicine as well as the efficacy of FoTv in a larger study population.

Conditions: COVID-19
Being tested: FoTv
Medical subject headings: COVID-19

What participants receive

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

FoTvDrug
Also called Fomitopsis officinalis and Trametes versicolor
8 capsules three times a day for 14 consecutive days.

Study groups in NCT04667247
Study group	Role	What they receive
Mushrooms	Experimental	Fomitopsis officinalis and Trametes versicolor Receives: Drug: FoTv
Placebo	Placebo comparator	Organic brown rice Receives: Drug: FoTv

What is being measured

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

Total Protein Normal to Abnormal Transition
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion 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
Albumin Normal to Abnormal Transition
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion 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
Alkaline Phosphatase Normal to Abnormal Transition
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion 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
AST Normal to Abnormal Transition
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion 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
ALT Normal to Abnormal Transition
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion 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
Bilirubin Normal to Abnormal Transition
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion 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
Adj. EGFR Normal to Abnormal Transition
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion 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
Prothrombin Time Normal to Abnormal Transition
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion 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
APTT Normal to Abnormal Transition
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion 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
ESR Normal to Abnormal Transition
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion 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
CRP Normal to Abnormal Transition
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion 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
LDH Normal to Abnormal Transition
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion 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 (15)

Total Bilirubin
comparison of the Total Bilirubin of baseline laboratory data with end-of-treatment labs
Measured: 14 days
Prothrombin Time
comparison of the prothrombin time of baseline laboratory data with end-of-treatment labs
Measured: 14 days
Aspartate Aminotransferase (AST)
Comparison of the aspartate transaminase of baseline laboratory data with end-of-treatment labs
Measured: 14 days
Alanine Transaminase (ALT)
The safety of the study medication will also assessed by a comparison of the alanine transaminase of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients)
Measured: 14 days
Albumin
comparing Albumin of baseline laboratory data with end-of-treatment labs
Measured: 14 days
Alkaline Phosphatase
comparing the Alkaline Phosphatase of baseline laboratory data with end-of-treatment labs
Measured: 14 days
Lactate Dehydrogenase
A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the serum Lactate Dehydrogenase level of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).
Measured: 14 days
C-Reactive Protein
A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the serum C-Reactive Protein level of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).
Measured: 14 days
Mid-turbinate SARS CoV-2 Viral Load
A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by changes in the SARS CoV-2 viral loads among mid-turbinate nasal swabs taken on days 0, 4, 7 and 14.
Measured: 14 days
Adj. EGFR
A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the Adj. EGFR of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).
Measured: 14 days
APTT
A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the APTT of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).
Measured: 14 days
INR
A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the INR of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). The INR is a result of a blood test that measures how long it takes for blood to clot, also known as the prothrombin time (PT). The INR is calculated by comparing the PT to the mean normal prothrombin time (MNPT).
Measured: 14 days
ESR
A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the ESR of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).
Measured: 14 days
Symptom Count
Symptom severity was assessed via a daily questionnaire across Days 0-14, where participants rated their symptoms on a scale of 0 (none or absent) to 3 (severe). A composite measure was created for each day, based on the 12 symptoms most commonly associated with COVID-19 (fever, fatigue, muscle aches, shortness of breath, shortness of breath upon exertion, cough, sore throat, stuffy nose, runny nose, loss of taste, loss of smell, headache), and counting the total number of symptoms present. scores of 1 or more were considered to be present.
Measured: 14 days
Symptom Severities
Symptom severity was assessed via a daily questionnaire across Days 0-14, where participants rated their symptoms on a scale of 0 (none or absent) to 3 (severe). A composite measure was created for each day, based on the 12 symptoms most commonly associated with COVID-19 (fever, fatigue, muscle aches, shortness of breath, shortness of breath upon exertion, cough, sore throat, stuffy nose, runny nose, loss of taste, loss of smell, headache), and summing the total symptom severities. Higher symptom severities indicates a worse outcome. The minimum and maximum were: 0 to 36, respectively.
Measured: 14 days

Timeline

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

23 Dec 20204 May 2022

First posted14 Dec 2020
Study start23 Dec 2020
Primary completion21 Mar 2022
Study completion4 May 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.
Other trials for COVID-19Studies of the same condition, open and under way.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04667247
Sponsor's protocol ID: 200633-1a
Acronym: MACH19
Status last verified: Aug 2025
First submitted: 3 Dec 2020
Last updated: 19 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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 19 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 and Trametes Versicolor to Treat COVID-19
ClinicalTrials.gov ID: NCT04667247
Acronym / sponsor ID: MACH19 / 200633-1a
Conditions: COVID-19
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Gordon SaxeUniversity, hospital or other
Collaborators: University of California, Los Angeles, University of California, Irvine
Study start: 23 Dec 2020 (actual)
Primary completion: 21 Mar 2022 (actual)
Study completion: 4 May 2022 (actual)
First posted: 14 Dec 2020 (actual)
Results: Posted 19 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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Mushrooms	Experimental	Drug: FoTvFomitopsis officinalis and Trametes versicolor
Placebo	Placebo comparator	Drug: FoTvOrganic brown rice

Who may qualify

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

Key inclusion criteria (5 listed)

Positive COVID-19 diagnosis within the prior 72 hours
Age 18 years and older
Women of childbearing potential must have a negative urine or serum hCG. Women of childbearing potential must have a negative serum pregnancy test at screening and agree to use contraception throughout the study period.
Capable of documenting vitals, symptoms, and study product intake daily and communicating this information to the study team
Willing to avoid alcohol, cannabis, and dairy products during the study period.

Key exclusion criteria (10 listed)

Any of the following symptoms which, according to the CDC, require hospitalization:
Current use of investigational agents to prevent or treat COVID-19
Known liver disease (ALT/AST >3x ULN or diagnosis of cirrhosis)
Known renal disease (eGFR < 60 ml/min) or acute nephritis.
Uncontrolled hypertension (SBP>140 or DBP>90 while on medications)

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
FoTvAlso: Fomitopsis officinalis and Trametes versicolor8 capsules three times a day for 14 consecutive days.	Drug	Mushrooms, Placebo

Primary outcome

Total Protein Normal to Abnormal Transition
Time frame: 14 days
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Albumin Normal to Abnormal Transition
Time frame: 14 days
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Alkaline Phosphatase Normal to Abnormal Transition
Time frame: 14 days
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
AST Normal to Abnormal Transition
Time frame: 14 days
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
ALT Normal to Abnormal Transition
Time frame: 14 days
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Bilirubin Normal to Abnormal Transition
Time frame: 14 days
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Adj. EGFR Normal to Abnormal Transition
Time frame: 14 days
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Prothrombin Time Normal to Abnormal Transition
Time frame: 14 days
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
APTT Normal to Abnormal Transition
Time frame: 14 days
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
ESR Normal to Abnormal Transition
Time frame: 14 days
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
CRP Normal to Abnormal Transition
Time frame: 14 days
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
LDH Normal to Abnormal Transition
Time frame: 14 days
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

15 secondary outcomes

Total Bilirubin
Time frame: 14 days
Prothrombin Time
Time frame: 14 days
Aspartate Aminotransferase (AST)
Time frame: 14 days
Alanine Transaminase (ALT)
Time frame: 14 days
Albumin
Time frame: 14 days
Alkaline Phosphatase
Time frame: 14 days
Lactate Dehydrogenase
Time frame: 14 days
C-Reactive Protein
Time frame: 14 days
Mid-turbinate SARS CoV-2 Viral Load
Time frame: 14 days
Adj. EGFR
Time frame: 14 days
APTT
Time frame: 14 days
INR
Time frame: 14 days
ESR
Time frame: 14 days
Symptom Count
Time frame: 14 days
Symptom Severities
Time frame: 14 days

Results and safety

Results posted to the registry on 19 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	28	28
Placebo	26	25

Primary outcome: Total Protein Normal to Abnormal Transition

Time frame: 14 days. Number. Unit: percentage of participants

Measure	Mushrooms n = 22	Placebo n = 23
Value	0	0

Population analysed: All participants who were normal at baseline were also normal at day 14, so Chi-square statistic could not be computed.

Primary outcome: Albumin Normal to Abnormal Transition

Time frame: 14 days. Number. Unit: percentage of participants

Measure	Mushrooms n = 25	Placebo n = 23
Value	4	0

Mushrooms vs Placebo: ratio of frequencies: .940, p = 1.000, Chi-squared, Corrected

Primary outcome: Alkaline Phosphatase Normal to Abnormal Transition

Time frame: 14 days. Number. Unit: percentage of participants

Measure	Mushrooms n = 24	Placebo n = 23
Value	0	0

Population analysed: Chi-square statistic could not be computed because all participants who were normal at baseline were also normal at day 14.

Primary outcome: AST Normal to Abnormal Transition

Time frame: 14 days. Number. Unit: percentage of participants

Measure	Mushrooms n = 25	Placebo n = 24
Value	0	0

Population analysed: Chi-square statistic could not be computed because all participants who were normal at baseline were also normal at day 14.

15 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 26 (0%)	1 of 26 (3.8%)	0 of 26
Placebo	0 of 24 (0%)	2 of 24 (8.3%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing FoTv in people with COVID-19, run by Gordon Saxe at 2 sites 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 5 inclusion and 10 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 19 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 2 sites 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Yes. Results are posted in the registry (first posted 19 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?

Total Protein Normal to Abnormal Transition (time frame: 14 days). The study lists 12 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 NCT04667247.

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 19 Aug 2025.