Clinical trial NCT04951336: RCT of Mushroom Based Natural Product to Enhance Immune Response to COVID-19 Vaccination
Official title: Multicenter Double-Blind, Placebo-Controlled RCT of Fomitopsis Officinalis/Trametes Versicolor for COVID-19
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: COVID-19 Vaccination
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Mix model involving two groups and multiple measurements across study time-points
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Creatinine concentration
timeFrame: 15 days
measure: Aspartate transaminase concentration
timeFrame: 15 days
measure: Alanine transaminase concentration
timeFrame: 15 days
measure: Albumine concentration
timeFrame: 15 days
measure: Bilirubin concentration
timeFrame: 15 days
measure: Electrolyte balance
timeFrame: 15 days
measure: SARS-CoV-2 Antibody titer
timeFrame: 180 days
measure: Duration (number of days) of post-vaccination symptoms
timeFrame: 4 days
measure: Severity scores of post-vaccination symptoms
timeFrame: 4 days
Secondary outcomes:
measure: Peripheral Blood Mononuclear Cell (PBMC) immune profiling
timeFrame: 180 days
Other outcomes:
Locations:
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: