RCT of Mushroom Based Natural Product to Enhance Immune Response to COVID-19 Vaccination (MACH19)

University of California San Diego

Status: Completed

Conditions: COVID-19 Vaccination

Treatments: Dietary Supplement: FoTv

Study type: Interventional

Funder types: Other

Identifiers

NCT04951336

200633-1c

Details and patient eligibility

About

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.

Full description

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 and immune response in 45 total subjects.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups, including a placebo group

Mushrooms

Experimental group

Description:

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.

Treatment:

Dietary Supplement: FoTv

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: FoTv