Clinical trial NCT04667247: Mushroom-based Product for COVID-19
Official title: Multicenter Double Blind, Placebo Controlled RCT of Fomitopsis Officinalis and Trametes Versicolor to Treat COVID-19
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: COVID-19
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: University of California, Irvine
First posted: 2020-12-14
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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responses associated with both immune-activation and resolution of host defense- induced inflammatory reactions (unpublished).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

Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events
timeFrame: 2 months
measure: Creatinine
timeFrame: 2 months
measure: Aspartate transaminase
timeFrame: 2 months
measure: Alanine transaminase
timeFrame: 2 months
measure: Prothrombin time
timeFrame: 2 months
measure: Partial Thromboplastin Time
timeFrame: 2 months
Secondary outcomes:
measure: Duration of viral illness
timeFrame: 6 months
measure: Hospitalization rate
timeFrame: 6 months
measure: ICU admission
timeFrame: 6 months
measure: Ventilatory requirement
timeFrame: 6 months
measure: Lymphocyte count
timeFrame: 6 months
measure: Neutrophil count
timeFrame: 6 months
measure: Ferritin
timeFrame: 6 months
measure: D-Dimer
timeFrame: 6 months
measure: Lactate Dehydrogenase
timeFrame: 6 months
measure: C-Reactive Protein
timeFrame: 6 months
measure: Troponin
timeFrame: 6 months
measure: Mid-turbinate nasal swabs
timeFrame: 6 months
measure: Peripheral Blood Mononuclear Cell (PBMC) immune profiling
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Andrew Shubov, MD
role: PRINCIPAL_INVESTIGATOR
References: