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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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, neutralizing antibody, and immune response in 45 total subjects

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

Conditions
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COVID-19 Vaccination

Intervention / Treatment
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* Dietary Supplement: FoTv


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Known liver disease (or diagnosis of cirrhosis) Known renal disease or acute nephritis. Pregnant or breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Mix model involving two groups and multiple measurements across study time-points
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mushrooms<br>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. | Dietary Supplement: FoTv<br>* Fomitopsis Officinalis and Trametes Versicolor<br>|
| Placebo Comparator: Placebo<br>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. | Dietary Supplement: FoTv<br>* Fomitopsis Officinalis and Trametes Versicolor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatinine concentration | The safety of the study medication will be assessed by a comparison of the serum creatinine level of baseline laboratory data with end-of-treatment labs | 15 days | 
| Aspartate transaminase concentration | The safety of the study medication will be assessed by a comparison of the serum AST level of baseline laboratory data with end-of-treatment labs | 15 days | 
| Alanine transaminase concentration | The safety of the study medication will be assessed by a comparison of the serum ALT level of baseline laboratory data with end-of-treatment labs | 15 days | 
| Albumine concentration | The safety of the study medication will be assessed by a comparison of the serum albumine level of baseline laboratory data with end-of-treatment labs | 15 days | 
| Bilirubin concentration | The safety of the study medication will be assessed by a comparison of the serum bilirubin level of baseline laboratory data with end-of-treatment labs | 15 days | 
| Electrolyte balance | The safety of the study medication will be assessed by a comparison of the serum electrolyte levels of baseline laboratory data with end-of-treatment labs | 15 days | 
| SARS-CoV-2 Antibody titer | The effect of study medication will be assessed by a comparison of the plasma antibody titer among subjects in active arm compared with placebo | 180 days | 
| Duration (number of days) of post-vaccination symptoms | Objective will be to evaluate post-vaccination symptoms duration (number of days) among subjects in the active arm compared with placebo | 4 days | 
| Severity scores of post-vaccination symptoms | Objective will be to evaluate post-vaccination symptoms severity total score among subjects in the active arm compared with placebo | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral Blood Mononuclear Cell (PBMC) immune profiling | Exploratory objective will be to evaluate immune response to COVID-19 vaccination in the presence of FoTv compared to placebo arm | 180 days |