RCT of Mushroom Based Natural Product to Enhance Immune Response to COVID-19 Vaccination
- Conditions
- COVID-19 Vaccination
- Registration Number
- NCT04951336
- Lead Sponsor
- University of California, San Diego
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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
- Known liver disease (or diagnosis of cirrhosis)
- Known renal disease or acute nephritis.
- Pregnant or breastfeeding women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Aspartate transaminase concentration 15 days 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
Alanine transaminase concentration 15 days 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
Severity scores of post-vaccination symptoms 4 days Objective will be to evaluate post-vaccination symptoms severity total score among subjects in the active arm compared with placebo
Creatinine concentration 15 days 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
Duration (number of days) of post-vaccination symptoms 4 days Objective will be to evaluate post-vaccination symptoms duration (number of days) among subjects in the active arm compared with placebo
Electrolyte balance 15 days 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
Albumine concentration 15 days 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
Bilirubin concentration 15 days 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
SARS-CoV-2 Antibody titer 180 days The effect of study medication will be assessed by a comparison of the plasma antibody titer among subjects in active arm compared with placebo
- Secondary Outcome Measures
Name Time Method Peripheral Blood Mononuclear Cell (PBMC) immune profiling 180 days Exploratory objective will be to evaluate immune response to COVID-19 vaccination in the presence of FoTv compared to placebo arm
Trial Locations
- Locations (1)
University of California, San Diego
🇺🇸San Diego, California, United States
University of California, San Diego🇺🇸San Diego, California, United States