RCT of Fomitopsis Officinalis and Trametes Versicolor to Treat COVID-19 (MACH19)

Gordon Saxe

Status and phase

Completed

Phase 2

Phase 1

Conditions

COVID-19

Treatments

Drug: FoTv

Study type

Interventional

Funder types

Other

Identifiers

NCT04667247

200633-1a

Details and patient eligibility

About

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.

Full 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responses associated with both immune-activation and resolution of host defense- induced inflammatory reactions (unpublished).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.

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

Any of the following symptoms which, according to the CDC, require hospitalization:
1. Trouble breathing
2. Persistent pain or pressure in the chest
3. New confusion or inability to arouse
4. 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