COVID-19
Conditions
Brief summary
This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate two polypore mushrooms, Fomitopsis officinalis and Trametes versicolor (FoTv), to treat COVID-19-positive outpatients with mild-to-moderate symptoms assigned to self-quarantined and home management. The study aims to establish the safety and feasibility of the use of FoTv vs placebo in 66 total subjects.
Detailed description
Despite biomedical advances, medical intervention for COVID-19 is largely limited to vaccinations and supportive care during the later stages of disease. While antiviral, anti-inflammatory, and antimalarial options have been explored for later stages of disease, fewer studies have been conducted on medications to reduce the risk of outpatient cases progressing to severe disease. Therefore, it is important that we broaden the search to include agents outside of our usual pharmacopeia. Integrative Medicine offers several promising therapeutics that are available today and warrant investigation. Some of the botanicals used for their possible immune modulating functions include polypore mushrooms. Among these, Turkey Tail (Trametes versicolor) has a long history of use for its immune supporting properties. An RCT examining the effects of Trametes versicolor in breast cancer patients detected increases in lymphocyte counts and natural killer cell functional activity (Torkelson et al, 2012 and Benson et al, 2019) both of which are key to host COVID-19 response. Further investigations into other relevant mushroom species demonstrated that Agarikon (Fomitopsis officinalis) can strongly induce an array of differential cytokine responses associated with both immune-activation and resolution of host defense- induced inflammatory reactions (unpublished). This homeostatic effect deserves attention for COVID-19 given the high mortality rate associated with cytokine storm. This is a multi-center, randomized, double blind, placebo-controlled clinical trial to evaluate two polypore mushrooms, Fomitopsis officinalis and Trametes versicolor (FoTv), to treat COVID-19-positive outpatients with mild-to-moderate symptoms assigned to self-quarantined and home management. This study aims to establish the safety and feasibility of the use of FoTv vs placebo in 66 total subjects. Subsequent trials will evaluate Chinese herbal medicine as well as the efficacy of FoTv in a larger study population.
Interventions
DRUGFoTv
8 capsules three times a day for 14 consecutive days.
Sponsors
University of California, Los Angeles
University of California, Irvine
Gordon Saxe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Positive COVID-19 diagnosis within the prior 72 hours * Age 18 years and older * Women of childbearing potential must have a negative urine or serum hCG. Women of childbearing potential must have a negative serum pregnancy test at screening and agree to use contraception throughout the study period. * Capable of documenting vitals, symptoms, and study product intake daily and communicating this information to the study team * Willing to avoid alcohol, cannabis, and dairy products during the study period.
Exclusion criteria
* Any of the following symptoms which, according to the CDC, require hospitalization: 1. Trouble breathing 2. Persistent pain or pressure in the chest 3. New confusion or inability to arouse 4. Bluish lips or face * Current use of investigational agents to prevent or treat COVID-19 * Known liver disease (ALT/AST \>3x ULN or diagnosis of cirrhosis) * Known renal disease (eGFR \< 60 ml/min) or acute nephritis. * Uncontrolled hypertension (SBP\>140 or DBP\>90 while on medications) * Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Protein Normal to Abnormal Transition | 14 days | We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline. |
| Albumin Normal to Abnormal Transition | 14 days | We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline. |
| Alkaline Phosphatase Normal to Abnormal Transition | 14 days | We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline. |
| AST Normal to Abnormal Transition | 14 days | We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline. |
| ALT Normal to Abnormal Transition | 14 days | We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline. |
| Bilirubin Normal to Abnormal Transition | 14 days | We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline. |
| Adj. EGFR Normal to Abnormal Transition | 14 days | We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline. |
| Prothrombin Time Normal to Abnormal Transition | 14 days | We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline. |
| APTT Normal to Abnormal Transition | 14 days | We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline. |
| ESR Normal to Abnormal Transition | 14 days | We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline. |
| CRP Normal to Abnormal Transition | 14 days | We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline. |
| LDH Normal to Abnormal Transition | 14 days | We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ESR | 14 days | A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the ESR of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). |
| Total Bilirubin | 14 days | comparison of the Total Bilirubin of baseline laboratory data with end-of-treatment labs |
| Symptom Severities | 14 days | Symptom severity was assessed via a daily questionnaire across Days 0-14, where participants rated their symptoms on a scale of 0 (none or absent) to 3 (severe). A composite measure was created for each day, based on the 12 symptoms most commonly associated with COVID-19 (fever, fatigue, muscle aches, shortness of breath, shortness of breath upon exertion, cough, sore throat, stuffy nose, runny nose, loss of taste, loss of smell, headache), and summing the total symptom severities. Higher symptom severities indicates a worse outcome. The minimum and maximum were: 0 to 36, respectively. |
| Symptom Count | 14 days | Symptom severity was assessed via a daily questionnaire across Days 0-14, where participants rated their symptoms on a scale of 0 (none or absent) to 3 (severe). A composite measure was created for each day, based on the 12 symptoms most commonly associated with COVID-19 (fever, fatigue, muscle aches, shortness of breath, shortness of breath upon exertion, cough, sore throat, stuffy nose, runny nose, loss of taste, loss of smell, headache), and counting the total number of symptoms present. scores of 1 or more were considered to be present. |
| Prothrombin Time | 14 days | comparison of the prothrombin time of baseline laboratory data with end-of-treatment labs |
| Aspartate Aminotransferase (AST) | 14 days | Comparison of the aspartate transaminase of baseline laboratory data with end-of-treatment labs |
| Alanine Transaminase (ALT) | 14 days | The safety of the study medication will also assessed by a comparison of the alanine transaminase of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients) |
| Albumin | 14 days | comparing Albumin of baseline laboratory data with end-of-treatment labs |
| Alkaline Phosphatase | 14 days | comparing the Alkaline Phosphatase of baseline laboratory data with end-of-treatment labs |
| Lactate Dehydrogenase | 14 days | A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the serum Lactate Dehydrogenase level of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). |
| C-Reactive Protein | 14 days | A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the serum C-Reactive Protein level of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). |
| Mid-turbinate SARS CoV-2 Viral Load | 14 days | A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by changes in the SARS CoV-2 viral loads among mid-turbinate nasal swabs taken on days 0, 4, 7 and 14. |
| Adj. EGFR | 14 days | A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the Adj. EGFR of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). |
| APTT | 14 days | A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the APTT of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). |
| INR | 14 days | A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the INR of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). The INR is a result of a blood test that measures how long it takes for blood to clot, also known as the prothrombin time (PT). The INR is calculated by comparing the PT to the mean normal prothrombin time (MNPT). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mushrooms Fomitopsis officinalis and Trametes versicolor
FoTv: 8 capsules three times a day for 14 consecutive days. | 26 |
| Placebo Organic brown rice
FoTv: 8 capsules three times a day for 14 consecutive days. | 24 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Mushrooms | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 43.27 years STANDARD_DEVIATION 11.098 | 47.71 years STANDARD_DEVIATION 17.269 | 45.40 years STANDARD_DEVIATION 14.417 |
| Albumin Normal | 25 Participants | 23 Participants | 48 Participants |
| Alkaline Phosphatase Normal | 24 Participants | 23 Participants | 47 Participants |
| ALT Normal | 23 Participants | 23 Participants | 46 Participants |
| APTT Normal | 22 Participants | 19 Participants | 41 Participants |
| AST Normal | 25 Participants | 24 Participants | 49 Participants |
| CRP Normal | 13 Participants | 15 Participants | 28 Participants |
| eGFR Normal | 21 Participants | 14 Participants | 35 Participants |
| ESR Normal | 20 Participants | 15 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 6 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 18 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| LDH Normal | 13 Participants | 9 Participants | 22 Participants |
| Prothrombin Time Normal | 24 Participants | 21 Participants | 45 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 20 Participants | 22 Participants | 42 Participants |
| Region of Enrollment United States | 26 participants | 24 participants | 50 participants |
| Sex: Female, Male Female | 16 Participants | 16 Participants | 32 Participants |
| Sex: Female, Male Male | 10 Participants | 8 Participants | 18 Participants |
| Total Bilirubin Normal | 26 Participants | 24 Participants | 50 Participants |
| Total Protein Normal | 22 Participants | 23 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 24 |
| other Total, other adverse events | 1 / 26 | 2 / 24 |
| serious Total, serious adverse events | 0 / 26 | 0 / 24 |
Outcome results
Primary
Adj. EGFR Normal to Abnormal Transition
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Time frame: 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mushrooms | Adj. EGFR Normal to Abnormal Transition | 28.6 percentage of participants |
| Placebo | Adj. EGFR Normal to Abnormal Transition | 0 percentage of participants |
p-value: 0.061Chi-squared, Corrected
Primary
Albumin Normal to Abnormal Transition
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Time frame: 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mushrooms | Albumin Normal to Abnormal Transition | 4 percentage of participants |
| Placebo | Albumin Normal to Abnormal Transition | 0 percentage of participants |
p-value: 1Chi-squared, Corrected
Primary
Alkaline Phosphatase Normal to Abnormal Transition
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Time frame: 14 days
Population: Chi-square statistic could not be computed because all participants who were normal at baseline were also normal at day 14.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mushrooms | Alkaline Phosphatase Normal to Abnormal Transition | 0 percentage of participants |
| Placebo | Alkaline Phosphatase Normal to Abnormal Transition | 0 percentage of participants |
Primary
ALT Normal to Abnormal Transition
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Time frame: 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mushrooms | ALT Normal to Abnormal Transition | 4.3 percentage of participants |
| Placebo | ALT Normal to Abnormal Transition | 0 percentage of participants |
p-value: 1Chi-squared, Corrected
Primary
APTT Normal to Abnormal Transition
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Time frame: 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mushrooms | APTT Normal to Abnormal Transition | 4.5 percentage of participants |
| Placebo | APTT Normal to Abnormal Transition | 5.0 percentage of participants |
p-value: 1Chi-squared, Corrected
Primary
AST Normal to Abnormal Transition
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Time frame: 14 days
Population: Chi-square statistic could not be computed because all participants who were normal at baseline were also normal at day 14.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mushrooms | AST Normal to Abnormal Transition | 0 percentage of participants |
| Placebo | AST Normal to Abnormal Transition | 0 percentage of participants |
Primary
Bilirubin Normal to Abnormal Transition
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Time frame: 14 days
Population: Chi-square statistic could not be computed because all participants who were normal at baseline were also normal at day 14.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mushrooms | Bilirubin Normal to Abnormal Transition | 0 percentage of participants |
| Placebo | Bilirubin Normal to Abnormal Transition | 0 percentage of participants |
Primary
CRP Normal to Abnormal Transition
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Time frame: 14 days
Population: Chi-square statistic could not be computed because all participants who were normal at baseline were also normal at day 14.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mushrooms | CRP Normal to Abnormal Transition | 0 percentage of participants |
| Placebo | CRP Normal to Abnormal Transition | 0 percentage of participants |
Primary
ESR Normal to Abnormal Transition
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Time frame: 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mushrooms | ESR Normal to Abnormal Transition | 0 percentage of participants |
| Placebo | ESR Normal to Abnormal Transition | 14.3 percentage of participants |
p-value: 0.162Chi-squared, Corrected
Primary
LDH Normal to Abnormal Transition
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Time frame: 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mushrooms | LDH Normal to Abnormal Transition | 46.2 percentage of participants |
| Placebo | LDH Normal to Abnormal Transition | 37.5 percentage of participants |
p-value: 1Chi-squared, Corrected
Primary
Prothrombin Time Normal to Abnormal Transition
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Time frame: 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mushrooms | Prothrombin Time Normal to Abnormal Transition | 0 percentage of participants |
| Placebo | Prothrombin Time Normal to Abnormal Transition | 14.3 percentage of participants |
p-value: 0.1Chi-squared, Corrected
Primary
Total Protein Normal to Abnormal Transition
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Time frame: 14 days
Population: All participants who were normal at baseline were also normal at day 14, so Chi-square statistic could not be computed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mushrooms | Total Protein Normal to Abnormal Transition | 0 percentage of participants |
| Placebo | Total Protein Normal to Abnormal Transition | 0 percentage of participants |
Secondary
Adj. EGFR
A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the Adj. EGFR of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mushrooms | Adj. EGFR | Baseline | 111.93848626354 mL/min | Standard Deviation 20.474674486202 |
| Mushrooms | Adj. EGFR | Day 14 | 104.27777159545 mL/min | Standard Deviation 20.422794275258 |
| Placebo | Adj. EGFR | Baseline | 101.72611717162 mL/min | Standard Deviation 22.886437908934 |
| Placebo | Adj. EGFR | Day 14 | 103.86989833636 mL/min | Standard Deviation 21.26016848903 |
p-value: 0.01Mixed Models Analysis
Secondary
Alanine Transaminase (ALT)
The safety of the study medication will also assessed by a comparison of the alanine transaminase of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients)
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mushrooms | Alanine Transaminase (ALT) | Baseline | 28.15 U/L | Standard Deviation 21.78 |
| Mushrooms | Alanine Transaminase (ALT) | Day 14 | 22.62 U/L | Standard Deviation 11.876 |
| Placebo | Alanine Transaminase (ALT) | Baseline | 22.92 U/L | Standard Deviation 10.902 |
| Placebo | Alanine Transaminase (ALT) | Day 14 | 19.79 U/L | Standard Deviation 7.163 |
p-value: 0.612Mixed Models Analysis
Secondary
Albumin
comparing Albumin of baseline laboratory data with end-of-treatment labs
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mushrooms | Albumin | Baseline | 4.565 U/L | Standard Deviation 0.361 |
| Mushrooms | Albumin | Day 14 | 4.638 U/L | Standard Deviation 0.2899 |
| Placebo | Albumin | Baseline | 4.517 U/L | Standard Deviation 0.2729 |
| Placebo | Albumin | Day 14 | 4.558 U/L | Standard Deviation 0.2933 |
p-value: 0.69Mixed Models Analysis
Secondary
Alkaline Phosphatase
comparing the Alkaline Phosphatase of baseline laboratory data with end-of-treatment labs
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mushrooms | Alkaline Phosphatase | Baseline | 75.64 U/L | Standard Deviation 38.583 |
| Mushrooms | Alkaline Phosphatase | Day 14 | 68.50 U/L | Standard Deviation 20.09 |
| Placebo | Alkaline Phosphatase | Baseline | 76.29 U/L | Standard Deviation 22.894 |
| Placebo | Alkaline Phosphatase | Day 14 | 77.54 U/L | Standard Deviation 19.797 |
p-value: 0.109Mixed Models Analysis
Secondary
APTT
A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the APTT of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mushrooms | APTT | Baseline | 32.377 sec | Standard Deviation 3.0971 |
| Mushrooms | APTT | Day 14 | 32.108 sec | Standard Deviation 2.8652 |
| Placebo | APTT | Baseline | 32.233 sec | Standard Deviation 2.9762 |
| Placebo | APTT | Day 14 | 31.513 sec | Standard Deviation 3.0824 |
p-value: 0.56Mixed Models Analysis
Secondary
Aspartate Aminotransferase (AST)
Comparison of the aspartate transaminase of baseline laboratory data with end-of-treatment labs
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mushrooms | Aspartate Aminotransferase (AST) | Baseline | 23.50 U/L | Standard Deviation 7.814 |
| Mushrooms | Aspartate Aminotransferase (AST) | Day 14 | 20.73 U/L | Standard Deviation 4.944 |
| Placebo | Aspartate Aminotransferase (AST) | Baseline | 22.92 U/L | Standard Deviation 6.406 |
| Placebo | Aspartate Aminotransferase (AST) | Day 14 | 20.54 U/L | Standard Deviation 4.403 |
p-value: 0.841Mixed Models Analysis
Secondary
C-Reactive Protein
A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the serum C-Reactive Protein level of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mushrooms | C-Reactive Protein | Baseline | 0.9437 mg/dL | Standard Deviation 1.1563 |
| Mushrooms | C-Reactive Protein | Day 14 | 0.3325 mg/dL | Standard Deviation 0.47883 |
| Placebo | C-Reactive Protein | Baseline | 0.5452 mg/dL | Standard Deviation 0.38384 |
| Placebo | C-Reactive Protein | Day 14 | 0.3686 mg/dL | Standard Deviation 0.44187 |
p-value: 0.044Mixed Models Analysis
Secondary
ESR
A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the ESR of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mushrooms | ESR | Baseline | 12.54 mm/hr | Standard Deviation 9.288 |
| Mushrooms | ESR | Day 14 | 11.13 mm/hr | Standard Deviation 13.766 |
| Placebo | ESR | Baseline | 14.89 mm/hr | Standard Deviation 13.78 |
| Placebo | ESR | Day 14 | 12.68 mm/hr | Standard Deviation 10.409 |
p-value: 0.765Mixed Models Analysis
Secondary
INR
A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the INR of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). The INR is a result of a blood test that measures how long it takes for blood to clot, also known as the prothrombin time (PT). The INR is calculated by comparing the PT to the mean normal prothrombin time (MNPT).
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mushrooms | INR | Day 14 | 1.054 ratio | Standard Deviation 0.0588 |
| Mushrooms | INR | Baseline | 1.073 ratio | Standard Deviation 0.0604 |
| Placebo | INR | Baseline | 1.048 ratio | Standard Deviation 0.0593 |
| Placebo | INR | Day 14 | 1.033 ratio | Standard Deviation 0.0565 |
p-value: 0.707Mixed Models Analysis
Secondary
Lactate Dehydrogenase
A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the serum Lactate Dehydrogenase level of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mushrooms | Lactate Dehydrogenase | Baseline | 186.08 U/L | Standard Deviation 29.02 |
| Mushrooms | Lactate Dehydrogenase | Day 14 | 195.77 U/L | Standard Deviation 33.448 |
| Placebo | Lactate Dehydrogenase | Baseline | 195.38 U/L | Standard Deviation 41.484 |
| Placebo | Lactate Dehydrogenase | Day 14 | 207.70 U/L | Standard Deviation 37.92 |
p-value: 0.844Mixed Models Analysis
Secondary
Mid-turbinate SARS CoV-2 Viral Load
A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by changes in the SARS CoV-2 viral loads among mid-turbinate nasal swabs taken on days 0, 4, 7 and 14.
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mushrooms | Mid-turbinate SARS CoV-2 Viral Load | Baseline | 15.2895 copies per mL | Standard Deviation 4.93549 |
| Mushrooms | Mid-turbinate SARS CoV-2 Viral Load | Day 7 | 27.7164 copies per mL | Standard Deviation 9.02866 |
| Mushrooms | Mid-turbinate SARS CoV-2 Viral Load | Day 14 | 37.7235 copies per mL | Standard Deviation 5.14676 |
| Placebo | Mid-turbinate SARS CoV-2 Viral Load | Baseline | 14.9429 copies per mL | Standard Deviation 4.65693 |
| Placebo | Mid-turbinate SARS CoV-2 Viral Load | Day 7 | 32.3462 copies per mL | Standard Deviation 7.83317 |
| Placebo | Mid-turbinate SARS CoV-2 Viral Load | Day 14 | 37.4067 copies per mL | Standard Deviation 4.78418 |
p-value: 0.989Mixed Models Analysis
Secondary
Prothrombin Time
comparison of the prothrombin time of baseline laboratory data with end-of-treatment labs
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mushrooms | Prothrombin Time | Day 14 | 11.342 sec | Standard Deviation 0.5687 |
| Mushrooms | Prothrombin Time | Baseline | 11.515 sec | Standard Deviation 0.7656 |
| Placebo | Prothrombin Time | Baseline | 11.448 sec | Standard Deviation 0.9258 |
| Placebo | Prothrombin Time | Day 14 | 11.342 sec | Standard Deviation 1.1477 |
p-value: 0.846Mixed Models Analysis
Secondary
Symptom Count
Symptom severity was assessed via a daily questionnaire across Days 0-14, where participants rated their symptoms on a scale of 0 (none or absent) to 3 (severe). A composite measure was created for each day, based on the 12 symptoms most commonly associated with COVID-19 (fever, fatigue, muscle aches, shortness of breath, shortness of breath upon exertion, cough, sore throat, stuffy nose, runny nose, loss of taste, loss of smell, headache), and counting the total number of symptoms present. scores of 1 or more were considered to be present.
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mushrooms | Symptom Count | Day 4 | 3.8077 Total Number of Symptoms | Standard Deviation 2.41693 |
| Mushrooms | Symptom Count | Day 8 | 2.8077 Total Number of Symptoms | Standard Deviation 2.28069 |
| Mushrooms | Symptom Count | Day 1 | 6.2692 Total Number of Symptoms | Standard Deviation 2.50691 |
| Mushrooms | Symptom Count | Day 9 | 2.4615 Total Number of Symptoms | Standard Deviation 2.12096 |
| Mushrooms | Symptom Count | Day 5 | 3.5385 Total Number of Symptoms | Standard Deviation 2.2491 |
| Mushrooms | Symptom Count | Day 10 | 2.3077 Total Number of Symptoms | Standard Deviation 2.2763 |
| Mushrooms | Symptom Count | Day 3 | 4.9615 Total Number of Symptoms | Standard Deviation 2.76378 |
| Mushrooms | Symptom Count | Day 11 | 1.6923 Total Number of Symptoms | Standard Deviation 2.07402 |
| Mushrooms | Symptom Count | Day 6 | 3.5000 Total Number of Symptoms | Standard Deviation 2.21359 |
| Mushrooms | Symptom Count | Day 12 | 1.3077 Total Number of Symptoms | Standard Deviation 1.56893 |
| Mushrooms | Symptom Count | Day 2 | 5.6154 Total Number of Symptoms | Standard Deviation 2.36773 |
| Mushrooms | Symptom Count | Day 13 | 1.1538 Total Number of Symptoms | Standard Deviation 1.48842 |
| Mushrooms | Symptom Count | Day 7 | 3.1538 Total Number of Symptoms | Standard Deviation 2.27495 |
| Mushrooms | Symptom Count | Day 14 | 1.1154 Total Number of Symptoms | Standard Deviation 1.65715 |
| Mushrooms | Symptom Count | Baseline (Day 0) | 7.2308 Total Number of Symptoms | Standard Deviation 2.30318 |
| Placebo | Symptom Count | Day 14 | 2.1667 Total Number of Symptoms | Standard Deviation 2.23931 |
| Placebo | Symptom Count | Baseline (Day 0) | 6.8750 Total Number of Symptoms | Standard Deviation 1.985 |
| Placebo | Symptom Count | Day 1 | 6.7083 Total Number of Symptoms | Standard Deviation 2.49311 |
| Placebo | Symptom Count | Day 2 | 6.1667 Total Number of Symptoms | Standard Deviation 2.86913 |
| Placebo | Symptom Count | Day 3 | 5.7083 Total Number of Symptoms | Standard Deviation 2.83578 |
| Placebo | Symptom Count | Day 4 | 5.2500 Total Number of Symptoms | Standard Deviation 2.95252 |
| Placebo | Symptom Count | Day 5 | 5.0000 Total Number of Symptoms | Standard Deviation 3.20326 |
| Placebo | Symptom Count | Day 6 | 4.5417 Total Number of Symptoms | Standard Deviation 2.57039 |
| Placebo | Symptom Count | Day 7 | 4.1667 Total Number of Symptoms | Standard Deviation 2.68112 |
| Placebo | Symptom Count | Day 8 | 3.6250 Total Number of Symptoms | Standard Deviation 2.85615 |
| Placebo | Symptom Count | Day 9 | 3.1667 Total Number of Symptoms | Standard Deviation 2.64849 |
| Placebo | Symptom Count | Day 10 | 3.0833 Total Number of Symptoms | Standard Deviation 2.68517 |
| Placebo | Symptom Count | Day 11 | 2.7917 Total Number of Symptoms | Standard Deviation 2.81269 |
| Placebo | Symptom Count | Day 12 | 2.6522 Total Number of Symptoms | Standard Deviation 2.26853 |
| Placebo | Symptom Count | Day 13 | 2.3750 Total Number of Symptoms | Standard Deviation 2.42832 |
p-value: 0.005Mixed Models Analysis
Secondary
Symptom Severities
Symptom severity was assessed via a daily questionnaire across Days 0-14, where participants rated their symptoms on a scale of 0 (none or absent) to 3 (severe). A composite measure was created for each day, based on the 12 symptoms most commonly associated with COVID-19 (fever, fatigue, muscle aches, shortness of breath, shortness of breath upon exertion, cough, sore throat, stuffy nose, runny nose, loss of taste, loss of smell, headache), and summing the total symptom severities. Higher symptom severities indicates a worse outcome. The minimum and maximum were: 0 to 36, respectively.
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mushrooms | Symptom Severities | Day 3 | 7.2692 units on a scale | Standard Deviation 4.17188 |
| Mushrooms | Symptom Severities | Day 8 | 4.1154 units on a scale | Standard Deviation 3.65871 |
| Mushrooms | Symptom Severities | Day 9 | 3.8462 units on a scale | Standard Deviation 3.71691 |
| Mushrooms | Symptom Severities | Baseline (Day 0) | 13.6538 units on a scale | Standard Deviation 6.62687 |
| Mushrooms | Symptom Severities | Day 14 | 1.6154 units on a scale | Standard Deviation 2.65446 |
| Mushrooms | Symptom Severities | Day 4 | 6.0000 units on a scale | Standard Deviation 4.4 |
| Mushrooms | Symptom Severities | Day 5 | 5.6538 units on a scale | Standard Deviation 4.36296 |
| Mushrooms | Symptom Severities | Day 10 | 3.4231 units on a scale | Standard Deviation 3.63509 |
| Mushrooms | Symptom Severities | Day 2 | 8.8077 units on a scale | Standard Deviation 4.6305 |
| Mushrooms | Symptom Severities | Day 11 | 2.4615 units on a scale | Standard Deviation 3.03619 |
| Mushrooms | Symptom Severities | Day 12 | 2.1538 units on a scale | Standard Deviation 3.19615 |
| Mushrooms | Symptom Severities | Day 6 | 5.7308 units on a scale | Standard Deviation 4.26669 |
| Mushrooms | Symptom Severities | Day 13 | 1.9615 units on a scale | Standard Deviation 2.77821 |
| Mushrooms | Symptom Severities | Day 1 | 10.4615 units on a scale | Standard Deviation 5.57301 |
| Mushrooms | Symptom Severities | Day 7 | 4.8462 units on a scale | Standard Deviation 3.94657 |
| Placebo | Symptom Severities | Day 14 | 2.9167 units on a scale | Standard Deviation 3.53758 |
| Placebo | Symptom Severities | Baseline (Day 0) | 11.0833 units on a scale | Standard Deviation 4.26224 |
| Placebo | Symptom Severities | Day 1 | 10.4167 units on a scale | Standard Deviation 5.53186 |
| Placebo | Symptom Severities | Day 2 | 9.1667 units on a scale | Standard Deviation 5.18079 |
| Placebo | Symptom Severities | Day 3 | 8.8333 units on a scale | Standard Deviation 5.44272 |
| Placebo | Symptom Severities | Day 5 | 7.2917 units on a scale | Standard Deviation 5.08604 |
| Placebo | Symptom Severities | Day 6 | 7.3750 units on a scale | Standard Deviation 5.37152 |
| Placebo | Symptom Severities | Day 7 | 6.4167 units on a scale | Standard Deviation 5.03826 |
| Placebo | Symptom Severities | Day 9 | 4.1250 units on a scale | Standard Deviation 3.53015 |
| Placebo | Symptom Severities | Day 11 | 3.7083 units on a scale | Standard Deviation 4.01605 |
| Placebo | Symptom Severities | Day 4 | 8.4583 units on a scale | Standard Deviation 5.94159 |
| Placebo | Symptom Severities | Day 10 | 3.8750 units on a scale | Standard Deviation 3.46802 |
| Placebo | Symptom Severities | Day 12 | 3.5652 units on a scale | Standard Deviation 3.34156 |
| Placebo | Symptom Severities | Day 13 | 3.2500 units on a scale | Standard Deviation 3.74456 |
| Placebo | Symptom Severities | Day 8 | 5.1667 units on a scale | Standard Deviation 4.54606 |
p-value: <0.001Mixed Models Analysis
Secondary
Total Bilirubin
comparison of the Total Bilirubin of baseline laboratory data with end-of-treatment labs
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mushrooms | Total Bilirubin | Baseline | 0.4215 mg/dL | Standard Deviation 0.19164 |
| Mushrooms | Total Bilirubin | Day 14 | 0.5469 mg/dL | Standard Deviation 0.24245 |
| Placebo | Total Bilirubin | Day 14 | 0.4216 mg/dL | Standard Deviation 0.1895 |
| Placebo | Total Bilirubin | Baseline | 0.3650 mg/dL | Standard Deviation 0.13197 |
p-value: 0.174Mixed Models Analysis