Trial Outcomes & Findings for RCT of Mushroom Based Natural Product to Enhance Immune Response to COVID-19 Vaccination (NCT NCT04951336)

Last Updated: 2025-08-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

90 participants

Primary outcome timeframe

14 days

Results posted on

2025-08-17

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	52	38
Overall Study COMPLETED	51	38
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mushrooms n=52 Participants 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	Placebo n=38 Participants 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	Total n=90 Participants Total of all reporting groups
Age, Continuous	43.1 years STANDARD_DEVIATION 15.6 • n=99 Participants	33.5 years STANDARD_DEVIATION 13.9 • n=107 Participants	39.03 years STANDARD_DEVIATION 15.6 • n=206 Participants
Sex: Female, Male Female	31 Participants n=99 Participants	21 Participants n=107 Participants	52 Participants n=206 Participants
Sex: Female, Male Male	21 Participants n=99 Participants	17 Participants n=107 Participants	38 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	9 Participants n=99 Participants	8 Participants n=107 Participants	17 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Race (NIH/OMB) White	41 Participants n=99 Participants	26 Participants n=107 Participants	67 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants
Region of Enrollment United States	52 participants n=99 Participants	38 participants n=107 Participants	90 participants n=206 Participants
Aspartate Aminotransferase (AST) Normal	50 participants n=99 Participants	38 participants n=107 Participants	88 participants n=206 Participants
Alanine Transaminase (ALT) Normal	43 Participants n=99 Participants	34 Participants n=107 Participants	77 Participants n=206 Participants
Alkaline Phosphatase (ALP) Normal	52 Participants n=99 Participants	36 Participants n=107 Participants	88 Participants n=206 Participants
Adjusted glomerular filtration rate (Adj. eGFR) Normal	38 Participants n=99 Participants	35 Participants n=107 Participants	73 Participants n=206 Participants

PRIMARY outcome

Timeframe: 14 days

Population: 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.

Outcome measures

Outcome measures
Measure	Mushrooms n=50 Participants 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	Placebo n=38 Participants 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	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).	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).
AST Normal to Abnormal Transition	2.0 % of participants who transitioned	2.6 % of participants who transitioned	—	—

PRIMARY outcome

Timeframe: 14 days

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

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.

Outcome measures

Outcome measures
Measure	Mushrooms n=43 Participants 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	Placebo n=34 Participants 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	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).	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).
ALT Normal to Abnormal Transition	4.7 % of participants who transitioned	5.9 % of participants who transitioned	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mushrooms n=52 Participants 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	Placebo n=36 Participants 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	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).	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).
ALP Normal to Abnormal Transition	1.9 % of participants who transitioned	0 % of participants who transitioned	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mushrooms n=38 Participants 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	Placebo n=35 Participants 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	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).	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).
eGFR Normal to Abnormal Transition	10.5 % of participants who transitioned	2.9 % of participants who transitioned	—	—

SECONDARY outcome

Timeframe: 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.

Population: 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.

higher scores indicate higher levels of RBD levels

Outcome measures

Outcome measures
Measure	Mushrooms n=30 Participants 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	Placebo n=19 Participants 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	Placebo-Exposed n=25 Participants 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).	Placebo-Unexposed n=11 Participants 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).
SARS-CoV-2 Receptor Binding Domain (RBD) Day1	355.02881 binding antibody units/mL Standard Deviation 358.066647	1.29801 binding antibody units/mL Standard Deviation 1.937670	206.22357 binding antibody units/mL Standard Deviation 188.893233	1.35671 binding antibody units/mL Standard Deviation 2.474966
SARS-CoV-2 Receptor Binding Domain (RBD) Day3	541.90950 binding antibody units/mL Standard Deviation 456.766094	—	289.80001 binding antibody units/mL Standard Deviation 217.354133	—
SARS-CoV-2 Receptor Binding Domain (RBD) Day14	10116.05971 binding antibody units/mL Standard Deviation 6190.370668	700.61000 binding antibody units/mL Standard Deviation 2530.473761	10052.95574 binding antibody units/mL Standard Deviation 4834.742085	168.23960 binding antibody units/mL Standard Deviation 161.993614
SARS-CoV-2 Receptor Binding Domain (RBD) Day28	9674.97316 binding antibody units/mL Standard Deviation 5860.432037	3953.50332 binding antibody units/mL Standard Deviation 3460.118026	10469.33030 binding antibody units/mL Standard Deviation 3844.263396	5129.00732 binding antibody units/mL Standard Deviation 5704.361365
SARS-CoV-2 Receptor Binding Domain (RBD) 6month	3209.48933 binding antibody units/mL Standard Deviation 3720.168648	6178.44885 binding antibody units/mL Standard Deviation 8273.702523	3398.50612 binding antibody units/mL Standard Deviation 4093.456937	3359.28725 binding antibody units/mL Standard Deviation 5108.022295

SECONDARY outcome

higher scores indicate higher levels of Spike levels

Outcome measures

Outcome measures
Measure	Mushrooms n=30 Participants 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	Placebo n=19 Participants 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	Placebo-Exposed n=25 Participants 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).	Placebo-Unexposed n=11 Participants 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).
SARS-CoV-2 Spike Protein ("Spike"). Day1	247.56807 binding antibody units/mL Standard Deviation 258.452559	0.47756 binding antibody units/mL Standard Deviation 0.400992	149.40025 binding antibody units/mL Standard Deviation 119.995872	0.78453 binding antibody units/mL Standard Deviation 1.023236
SARS-CoV-2 Spike Protein ("Spike"). Day3	380.70020 binding antibody units/mL Standard Deviation 307.487759	—	205.36409 binding antibody units/mL Standard Deviation 143.342600	—
SARS-CoV-2 Spike Protein ("Spike"). Day14	4488.11297 binding antibody units/mL Standard Deviation 1542.141350	392.53283 binding antibody units/mL Standard Deviation 1047.729456	4877.87445 binding antibody units/mL Standard Deviation 1549.014480	224.88593 binding antibody units/mL Standard Deviation 242.109014
SARS-CoV-2 Spike Protein ("Spike"). Day28	3981.34227 binding antibody units/mL Standard Deviation 1366.702076	1958.70983 binding antibody units/mL Standard Deviation 1542.192284	4719.52003 binding antibody units/mL Standard Deviation 1192.604423	2383.29307 binding antibody units/mL Standard Deviation 2275.359574
SARS-CoV-2 Spike Protein ("Spike"). 6month	1544.40689 binding antibody units/mL Standard Deviation 1341.873844	2107.24372 binding antibody units/mL Standard Deviation 2696.389743	1546.52328 binding antibody units/mL Standard Deviation 1347.920386	1400.07776 binding antibody units/mL Standard Deviation 1673.265928

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mushrooms n=30 Participants 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	Placebo n=19 Participants 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	Placebo-Exposed n=25 Participants 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).	Placebo-Unexposed n=11 Participants 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).
Side-Effect Number Day1	0.6333 units on a scale Standard Deviation 1.73172	0.2632 units on a scale Standard Deviation 0.56195	0.5200 units on a scale Standard Deviation 0.77028	0.4545 units on a scale Standard Deviation 0.52223
Side-Effect Number Day2	2.9333 units on a scale Standard Deviation 2.36254	1.4737 units on a scale Standard Deviation 1.4737	3.2000 units on a scale Standard Deviation 2.92973	1.2727 units on a scale Standard Deviation 2.68667
Side-Effect Number Day3	3.2000 units on a scale Standard Deviation 2.70886	2.0526 units on a scale Standard Deviation 2.14667	3.3200 units on a scale Standard Deviation 2.62552	4.5455 units on a scale Standard Deviation 3.20511
Side-Effect Number Day4	1.5000 units on a scale Standard Deviation 2.17747	1.0526 units on a scale Standard Deviation 1.71509	2.2000 units on a scale Standard Deviation 2.56580	1.9091 units on a scale Standard Deviation 1.70027
Side-Effect Number Day5	1.0333 units on a scale Standard Deviation 1.62912	0.0526 units on a scale Standard Deviation 0.22942	0.9200 units on a scale Standard Deviation 1.55242	0.6364 units on a scale Standard Deviation 0.67420

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mushrooms n=30 Participants 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	Placebo n=19 Participants 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	Placebo-Exposed n=25 Participants 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).	Placebo-Unexposed n=11 Participants 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).
Side-Effect Severity Day1	1.0333 units on a scale Standard Deviation 3.06800	0.2632 units on a scale Standard Deviation 0.56195	0.6800 units on a scale Standard Deviation 1.14455	0.4545 units on a scale Standard Deviation 0.52223
Side-Effect Severity Day2	3.7600 units on a scale Standard Deviation 3.53883	2.4000 units on a scale Standard Deviation 5.34255	7.0000 units on a scale Standard Deviation 7.08520	4.0000 units on a scale Standard Deviation 7.12741
Side-Effect Severity Day3	4.6667 units on a scale Standard Deviation 5.93257	2.0000 units on a scale Standard Deviation 4.01386	5.6400 units on a scale Standard Deviation 5.38424	8.3636 units on a scale Standard Deviation 8.88001
Side-Effect Severity Day4	1.5667 units on a scale Standard Deviation 3.16972	0.7895 units on a scale Standard Deviation 1.43678	3.5600 units on a scale Standard Deviation 5.49303	2.5455 units on a scale Standard Deviation 2.84125
Side-Effect Severity Day5	0.9333 units on a scale Standard Deviation 1.70057	0.0526 units on a scale Standard Deviation 0.22942	1.2400 units on a scale Standard Deviation 2.61852	0.9091 units on a scale Standard Deviation 1.22103

Adverse Events

Mushrooms

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mushrooms n=52 participants at risk 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	Placebo n=38 participants at risk 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
Respiratory, thoracic and mediastinal disorders ER visit	0.00% 0/52 • 14 days	0.00% 0/38 • 14 days
Reproductive system and breast disorders hospitalization	0.00% 0/52 • 14 days	0.00% 0/38 • 14 days
Respiratory, thoracic and mediastinal disorders Urgent Care Visit	0.00% 0/52 • 14 days	0.00% 0/38 • 14 days

Other adverse events

Other adverse events
Measure	Mushrooms n=52 participants at risk 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	Placebo n=38 participants at risk 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
Hepatobiliary disorders ALP Normal to Abnormal Transition	1.9% 1/52 • Number of events 1 • 14 days	0.00% 0/36 • 14 days
Hepatobiliary disorders AST Normal to Abnormal Transition	2.0% 1/50 • Number of events 1 • 14 days	2.6% 1/38 • Number of events 1 • 14 days
Hepatobiliary disorders ALT Normal to Abnormal Transition	4.7% 2/43 • Number of events 2 • 14 days	5.9% 2/34 • Number of events 2 • 14 days
Renal and urinary disorders eGFR Normal to Abnormal Transition	10.5% 4/38 • Number of events 4 • 14 days	2.9% 1/35 • Number of events 1 • 14 days

Additional Information

Gordon Saxe, M.D./Ph.D.

Krupp Center for Integrative Research, University of California San Diego

Phone: 6195435765

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place