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

Not Applicable

Completed

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 and immune response in 45 total subjects.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 90

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
AST Normal to Abnormal Transition	14 days	The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that transitioned to abnormal at Day 14 relative to all participants with normal values at baseline.
ALT Normal to Abnormal Transition	14 days	The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
ALP Normal to Abnormal Transition	14 days	The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
eGFR Normal to Abnormal Transition	14 days	The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

Secondary Outcome Measures

Name	Time	Method
SARS-CoV-2 Receptor Binding Domain (RBD)	Single-dose vaccine (J&J): days 1, 14, and 28, and 6-months post-vaccination; two-dose vaccine (Pfizer or Moderna): days 1, 14, and 42 (two weeks after second dose), and 6-months post-vaccination; and vaccine booster: days 1, 3, and 14, and 6-months.	higher scores indicate higher levels of RBD levels
SARS-CoV-2 Spike Protein ("Spike").	Single-dose vaccine (J&J): days 1, 14, and 28, and 6-months post-vaccination; two-dose vaccine (Pfizer or Moderna): days 1, 14, and 42 (two weeks after second dose), and 6-months post-vaccination; and vaccine booster: days 1, 3, and 14, and 6-months.	higher scores indicate higher levels of Spike levels
Side-Effect Number	Days, 1, 2, 3, 4, 5	count of the number of CDC side effects associated with vaccine. higher scores indicate higher number of endorsed side effects. Count of: feeling feverish, low fever in the afternoon, alternating fever and chills, chills, fatigue, muscle aches, nausea, headaches, redness/swelling at injection site, and pain at injection site. The range was from zero to 10.
Side-Effect Severity	Days, 1, 2, 3, 4, 5	Sum of the side effect severities for the CDC side effects associated with vaccine. higher scores indicate higher severity. The side effects included: feeling feverish, low fever in the afternoon, alternating fever and chills, chills, fatigue, muscle aches, nausea, headaches, redness/swelling at injection site, and pain at injection site. The scale for each side effect ranged from zero to 4. The total possible scale was zero to 40.

Trial Locations

Locations (1): University of California, San Diego
🇺🇸
San Diego, California, United States
University of California, San Diego
🇺🇸San Diego, California, United States