Turkey Tail - from forest trails to clinical trials
My previous post about the turkey tail mushroom (Trametes versicolor or Yun Zhi) is the most searched and viewed post on my blog! Clearly this fungus is the topic of a lot of interest.
So I was thrilled to discover it growing in the forests near my home on a mushroom forage walk last week! And I was even more thrilled to discover that it is currently the subject of an FDA approved clinical trial for use in mild-to-moderate Covid-19 patients in California!
If you are within 72 hours of a positive Covid-19 test, you may be eligible to participate in this study of a combination of Turkey Tail and Agarikon (Fomitopsis officinalis).
This study has different eligibility criteria from the modified Qing Fei Pai Du Tang study I also posted about, so it would be a great option if you are unable to take part in the Chinese Medicine study (which would still, personally, be my first choice).
If you are in the Los Angeles or San Diego areas and wish to take part in the study contact them at:
EMAIL - covid19trial@ucsd.edu
CALL - 858-249-6896
Click on the links below for more info, or keep scrolling down for all the details…
Mushroom-based Product for COVID-19
a study on COVID-19
Summary
Eligibility for people ages 18 years and up (full criteria)
Healthy Volunteers healthy people welcome
Location at UC Irvine UCLA UCSD
Dates study started December 3, 2020 estimated completion December 1, 2021
Principal Investigator by Andrew Shubov, MD (UCLA)
Description
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. The study aims to establish the safety and feasibility of the use of FoTv vs placebo in 66 total subjects.
OFFICIAL TITLE
Multicenter Double Blind, Placebo Controlled RCT of Fomitopsis Officinalis and Trametes Versicolor to Treat COVID-19
DETAILS
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.
KEYWORDS
COVID-19 FoTv Mushrooms
Eligibility
YOU CAN JOIN IF…
Open to people ages 18 years and up
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.
YOU CAN'T JOIN IF...
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
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
Locations
University of California, Los Angeles accepting new patients
Los AngelesCalifornia90095United StatesUniversity of California, San Diego accepting new patients
San DiegoCalifornia92093United States
Lead Scientist at University of California Health
Andrew Shubov, MD (UCLA)
HS Assistant Clinical Professor, Medicine.
Details
Status accepting new patients
Start Date December 3, 2020
Completion DateDecember 1, 2021 (estimated)
Sponsor Gordon Saxe
ID NCT04667247
Phase Phase 1/2
Study Type Interventional
Last Updated August 23, 2021