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

NCT04951336 | Completed Results DMC

• 1 other identifier: 200633-1c
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Vaccination

Outcome Measures

Primary Outcomes (4)

• AST Normal to Abnormal Transition

  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.

  14 days

• ALT Normal to Abnormal Transition

  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.

  14 days

• ALP Normal to Abnormal Transition

  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.

  14 days

• eGFR Normal to Abnormal Transition

  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.

  14 days

Secondary Outcomes (4)

• 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.

• 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.

• Side-Effect Number

  Days, 1, 2, 3, 4, 5

• Side-Effect Severity

  Days, 1, 2, 3, 4, 5

Study Arms (2)

Mushrooms

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

FoTv DIETARY_SUPPLEMENT

Fomitopsis Officinalis and Trametes Versicolor

Mushrooms; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known liver disease (or diagnosis of cirrhosis)
• Known renal disease or acute nephritis.
• Pregnant or breastfeeding women

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92093, United States

Location

Limitations and Caveats

Because of the rapidly changing nature of the COVID-19 pandemic, we didn't have sufficient time to ascertain, and stratify randomization based on, exposure status. Earlier launch might also have resulted in a larger proportion of Unexposed participants in the total sample. A 4-day treatment regimen was selected. Alternate dosing regimens at time of and immediately post-vaccination might have yielded different effects on Ab and other outcomes. we didn't examine Ab levels beyond 6-months.

Results Point of Contact

• Title: Gordon Saxe, M.D./Ph.D.
• Organization: Krupp Center for Integrative Research, University of California San Diego

gsaxe@health.ucsd.edu

6195435765

Study Officials

• Andrew Shubov, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Krupp Center for Integrative Research

Model Details: Mix model involving two groups and multiple measurements across study time-points

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 6, 2021
• Study Start: June 10, 2021
• Primary Completion: January 21, 2022
• Study Completion: July 6, 2022
• Last Updated: August 17, 2025
• Results First Posted: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)