RCT of Mushroom Based Natural Product to Enhance Immune R... | NCT04951336

RCT of Mushroom Based Natural Product to Enhance Immune R... | NCT04951336 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
FoTv	Dietary Supplement	Fomitopsis Officinalis and Trametes Versicolor	Mushrooms Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
SARS-CoV-2 Receptor Binding Domain (RBD)	higher scores indicate higher levels of RBD levels	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.

Contacts/Locations Module

Name	Affiliation	Role
Andrew Shubov, MD	University of California, Los Angeles	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Diego		San Diego	California	92093	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41620671	Derived	Saxe G, Smith CN, Golshan S, Shekhtman T, Bair ZJ, Beathard C, Davis RA, MacElhern L, Shubov A, Slater D, Kao LK, Senowitz P, Wilson S. Polypore mushroom mycelia as an adjunct to COVID-19 vaccination: a randomized clinical trial. BMC Immunol. 2026 Jan 31;27(1):24. doi: 10.1186/s12865-026-00809-9.

Arm/Group Information

ID	Title	Description
FG000	Mushrooms	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. FoTv: Fomitopsis Officinalis and Trametes Versicolor
FG001	Placebo	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. FoTv: Fomitopsis Officinalis and Trametes Versicolor

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00052 subjects FG00138 subjects
COMPLETED		FG00051 subjects FG00138 subjects
NOT COMPLETED		FG0001 subjects FG0010 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Mushrooms	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. FoTv: Fomitopsis Officinalis and Trametes Versicolor

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Number of participants who were normal at baseline. Participants who were abnormal at baseline were excluded, therefore the number of participants in this analysis is different from the total number of participants in the Mushrooms or Placebo groups described in the study arms/groups.

Posted

Number

% of participants who transitioned

14 days

ID	Title	Description
OG000	Mushrooms	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. FoTv: Fomitopsis Officinalis and Trametes Versicolor

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Mushrooms	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. FoTv: Fomitopsis Officinalis and Trametes Versicolor

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
ER visit	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	ER visit

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
ALP Normal to Abnormal Transition	Hepatobiliary disorders		Systematic Assessment	Transitioning from normal function at baseline to abnormal function at 14 days. ALP, alkaline phosphatase. Participants who were abnormal at baseline were excluded.

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Gordon Saxe, M.D./Ph.D.	Krupp Center for Integrative Research, University of California San Diego	6195435765		gsaxe@health.ucsd.edu

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 13, 2021	Aug 15, 2025	Prot_SAP_000.pdf

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG0020
Asian	BG0009 BG0018 BG00217
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020
Black or African American	BG0002 BG0011 BG0023
White	BG00041 BG00126 BG00267
More than one race	BG0000 BG0010 BG0020
Unknown or Not Reported	BG0000 BG0013 BG0023

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Chi-squared, Corrected		1.000		ratio of frequencies	0.04			2-Sided								Superiority

Primary

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.

Number of participants who were normal at baseline. Participants who were abnormal at baseline were excluded.

Posted

Number

% of participants who transitioned

14 days

ID	Title	Description
OG000	Mushrooms	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. FoTv: Fomitopsis Officinalis and Trametes Versicolor
OG001	Placebo	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. FoTv: Fomitopsis Officinalis and Trametes Versicolor

Units	Counts
Participants	OG00043 OG00134

Title

Denominators

Categories

Title	Measurements
	OG0004.7 OG0015.9

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Chi-squared, Corrected		1.000		ratio of frequencies	0.06			2-Sided								Superiority

Primary

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.

Posted

Number

% of participants who transitioned

14 days

ID	Title	Description
OG000	Mushrooms	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. FoTv: Fomitopsis Officinalis and Trametes Versicolor
OG001	Placebo	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. FoTv: Fomitopsis Officinalis and Trametes Versicolor

Units	Counts
Participants	OG00052 OG00136

Title

Denominators

Categories

Title	Measurements
	OG0001.9 OG0010

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Chi-squared, Corrected		1.000		ratio of frequencies	0.70			2-Sided								Superiority

Primary

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.

Posted

Number

% of participants who transitioned

14 days

ID	Title	Description
OG000	Mushrooms	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. FoTv: Fomitopsis Officinalis and Trametes Versicolor
OG001	Placebo	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. FoTv: Fomitopsis Officinalis and Trametes Versicolor

Units	Counts
Participants	OG00038 OG00135

Title

Denominators

Categories

Title	Measurements
	OG00010.5 OG0012.9

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Chi-squared, Corrected		0.359		ratio of frequencies	1.68			2-Sided								Superiority

Secondary

SARS-CoV-2 Receptor Binding Domain (RBD)

higher scores indicate higher levels of RBD levels

Five participants (3 in the Active group and 2 in the Placebo group) had 1 or more antibody test results that were considered outliers, and these participants were excluded from further antibody and side-effect analyses.

Posted

Mean

Standard Deviation

binding antibody units/mL

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.

ID	Title	Description
OG000	Active-Exposed	Participants were classified as either previously exposed (memory responses) or unexposed (primary responses) and analyzed within and across Exposure Strata. At baseline, participants with detectable anti-CoV-2 Abs were deemed "previously exposed" and those with no or very low anti-CoV-2 Abs "previously unexposed." Active received supplementation with FoTv.
OG001	Active-Unexposed	Participants were classified as either previously exposed (memory responses) or unexposed (primary responses) and analyzed within and across Exposure Strata. At baseline, participants with detectable anti-CoV-2 Abs were deemed "previously exposed" and those with no or very low anti-CoV-2 Abs "previously unexposed." Active received supplementation with FoTv.
OG002	Placebo-Exposed	Participants were classified as either previously exposed (memory responses) or unexposed (primary responses) and analyzed within and across Exposure Strata. At baseline, participants with detectable anti-CoV-2 Abs were deemed "previously exposed" and those with no or very low anti-CoV-2 Abs "previously unexposed." Placebo received supplementation with placebo (brown rice).
OG003	Placebo-Unexposed	Participants were classified as either previously exposed (memory responses) or unexposed (primary responses) and analyzed within and across Exposure Strata. At baseline, participants with detectable anti-CoV-2 Abs were deemed "previously exposed" and those with no or very low anti-CoV-2 Abs "previously unexposed." Placebo received supplementation with placebo (brown rice).

Units	Counts
Participants	OG00030 OG00119 OG00225 OG003

Title	Denominators	Categories
Day1	ParticipantsOG00030 ParticipantsOG00119 ParticipantsOG00225 ParticipantsOG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002 OG003	The LME analysis compared antibodies between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across four time points (days 3, 14, 28, and 6 months). At baseline, participants with detectable anti-CoV-2 antibodies were deemed "previously exposed" and those with no or very low anti-CoV-2 Abs "previously unexposed." Accordingly, all longitudinal analyses excluded baseline antibody data.	Mixed Models Analysis	F(2,150)=6.374. The analysis was repeated using log-transformed values and the resultant p value was also < 0.05	0.002	Differences were considered statistically significant for p-values <0.05.

Secondary

SARS-CoV-2 Spike Protein ("Spike").

higher scores indicate higher levels of Spike levels

Posted

Mean

Standard Deviation

binding antibody units/mL

ID	Title	Description
OG000	Active-Exposed	Participants were classified as either previously exposed (memory responses) or unexposed (primary responses) and analyzed within and across Exposure Strata. At baseline, participants with detectable anti-CoV-2 Abs were deemed "previously exposed" and those with no or very low anti-CoV-2 Abs "previously unexposed." Active received supplementation with FoTv.
OG001	Active-Unexposed	Participants were classified as either previously exposed (memory responses) or unexposed (primary responses) and analyzed within and across Exposure Strata. At baseline, participants with detectable anti-CoV-2 Abs were deemed "previously exposed" and those with no or very low anti-CoV-2 Abs "previously unexposed." Active received supplementation with FoTv.
OG002	Placebo-Exposed	Participants were classified as either previously exposed (memory responses) or unexposed (primary responses) and analyzed within and across Exposure Strata. At baseline, participants with detectable anti-CoV-2 Abs were deemed "previously exposed" and those with no or very low anti-CoV-2 Abs "previously unexposed." Placebo received supplementation with placebo (brown rice).
OG003	Placebo-Unexposed	Participants were classified as either previously exposed (memory responses) or unexposed (primary responses) and analyzed within and across Exposure Strata. At baseline, participants with detectable anti-CoV-2 Abs were deemed "previously exposed" and those with no or very low anti-CoV-2 Abs "previously unexposed." Placebo received supplementation with placebo (brown rice).

Units	Counts
Participants	OG00030 OG00119 OG00225 OG003

Title	Denominators	Categories
Day1	ParticipantsOG00030 ParticipantsOG00119 ParticipantsOG00225 ParticipantsOG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002 OG003	LME analysis compared antibodies between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across four time points (days 3, 14, 28, and 6 months). At baseline, participants with detectable anti-CoV-2 antibodies were deemed "previously exposed" and those with no or very low anti-CoV-2 Abs "previously unexposed." Accordingly, all longitudinal analyses excluded baseline antibody data.	Mixed Models Analysis	F(2,157)=4.286. The analysis was repeated using log-transformed values and the resultant p value was also < 0.05	0.002	p < 0.05.

Secondary

Side-Effect Number

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.

Posted

Mean

Standard Deviation

units on a scale

Days, 1, 2, 3, 4, 5

ID	Title	Description
OG000	Active-Exposed	Participants were classified as either previously exposed (memory responses) or unexposed (primary responses) and analyzed within and across Exposure Strata. At baseline, participants with detectable anti-CoV-2 Abs were deemed "previously exposed" and those with no or very low anti-CoV-2 Abs "previously unexposed." Active received supplementation with FoTv.
OG001	Active-Unexposed	Participants were classified as either previously exposed (memory responses) or unexposed (primary responses) and analyzed within and across Exposure Strata. At baseline, participants with detectable anti-CoV-2 Abs were deemed "previously exposed" and those with no or very low anti-CoV-2 Abs "previously unexposed." Active received supplementation with FoTv.
OG002	Placebo-Exposed	Participants were classified as either previously exposed (memory responses) or unexposed (primary responses) and analyzed within and across Exposure Strata. At baseline, participants with detectable anti-CoV-2 Abs were deemed "previously exposed" and those with no or very low anti-CoV-2 Abs "previously unexposed." Placebo received supplementation with placebo (brown rice).
OG003	Placebo-Unexposed	Participants were classified as either previously exposed (memory responses) or unexposed (primary responses) and analyzed within and across Exposure Strata. At baseline, participants with detectable anti-CoV-2 Abs were deemed "previously exposed" and those with no or very low anti-CoV-2 Abs "previously unexposed." Placebo received supplementation with placebo (brown rice).

Units	Counts
Participants	OG00030 OG00119 OG00225 OG003

Title

Denominators

Categories

Day1

Title	Measurements
	OG0000.6333± 1.73172 OG0010.2632± 0.56195 OG0020.5200± 0.77028 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002 OG003	LME analysis compared symptoms between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across 5 time points (days 1-5)	Mixed Models Analysis	F(8,325)=1.898. Age was included as a covariate in this analysis.	0.060														Superiority

Secondary

Side-Effect Severity

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.

Posted

Mean

Standard Deviation

units on a scale

Days, 1, 2, 3, 4, 5

ID	Title	Description
OG000	Active-Exposed	Participants were classified as either previously exposed (memory responses) or unexposed (primary responses) and analyzed within and across Exposure Strata. At baseline, participants with detectable anti-CoV-2 Abs were deemed "previously exposed" and those with no or very low anti-CoV-2 Abs "previously unexposed." Active received supplementation with FoTv.
OG001	Active-Unexposed	Participants were classified as either previously exposed (memory responses) or unexposed (primary responses) and analyzed within and across Exposure Strata. At baseline, participants with detectable anti-CoV-2 Abs were deemed "previously exposed" and those with no or very low anti-CoV-2 Abs "previously unexposed." Active received supplementation with FoTv.
OG002	Placebo-Exposed	Participants were classified as either previously exposed (memory responses) or unexposed (primary responses) and analyzed within and across Exposure Strata. At baseline, participants with detectable anti-CoV-2 Abs were deemed "previously exposed" and those with no or very low anti-CoV-2 Abs "previously unexposed." Placebo received supplementation with placebo (brown rice).
OG003	Placebo-Unexposed	Participants were classified as either previously exposed (memory responses) or unexposed (primary responses) and analyzed within and across Exposure Strata. At baseline, participants with detectable anti-CoV-2 Abs were deemed "previously exposed" and those with no or very low anti-CoV-2 Abs "previously unexposed." Placebo received supplementation with placebo (brown rice).

Units	Counts
Participants	OG00030 OG00119 OG00225 OG003

Title

Denominators

Categories

Day1

Title	Measurements
	OG0001.0333± 3.06800 OG0010.2632± 0.56195 OG0020.6800± 1.14455 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002 OG003		Mixed Models Analysis	F(8,309)=1.156. Age was included as a covariate in this analysis.	0.326														Superiority	LME analysis compared symptoms between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across 5 time points (days 1-5)