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This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate a 21-herb formula named modified Qing Fei Pai Du Tang (mQFPD) to treat COVID-19-positive outpatients with mild-to-moderate symptoms assigned to self-quarantined and home management. This the study aims to establish the safety and feasibility of the use of mQFPD vs placebo in 66 total subjects. Subsequent trials will evaluate other therapeutics as well as the efficacy of mQFPD in a larger study population.
Study participants will be assigned to one of two groups, either placebo or mQFPD. Participants will be screened and consented remotely. Both groups will receive blood draws at days 1 and 14, and will be sent study medication directly to their home from the investigational pharmacy. Baseline and end-of-study laboratory draws will be done at home via mobile phlebotomy. Adverse events and symptoms scores will be monitored by entry into a daily diary along with regular phone calls with the study coordinators.
At the end of the study, safety will be assessed by laboratory measures and adverse event reporting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| modified Qing Fei Pei Du Tang | Experimental | encapsulated modified Qing Fei Pai Du Tang |
|
| Placebo | Placebo Comparator | Organic brown rice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mQFPD | Drug | The dosage of mQFPD is 8 capsules three times a day for 14 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Protein 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 |
| Albumin 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 |
| Alkaline Phosphatase 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 |
| AST 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 |
| 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 |
| Bilirubin 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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, 7 and 14. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
Any of the following symptoms which, according to the CDC, require hospitalization:
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)
Allergy to tree nuts
Bleeding dyscrasia or on anticoagulation (aspirin and/or clopidogrel is allowed)
Pregnant or breastfeeding women
Use of Tolbutamide
Use of systemic corticosteroids (hydrocortisone, cortisone, prednisolone, betamethasone, methylprednisolone, prednisone, dexamethasone). Inhaled budesonide is to be allowed.
Use of digoxin
Use of Oxacillin
Use of Interferon
Use of Vincristine
Use of Cyclosporine
Use of Amiodarone
Patients with a past medical history of epilepsy
Use of monoamine oxidase inhibitors (MAOI)
Use of Methamphetamine within the prior 30 days
Use of Cocaine within the prior 30 days
Use of aminoglycosides, carbamazepine, flecainide, lithium, phenytoin, phenobarbital, rifampicin, theophylline and warfarin
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| Name | Affiliation | Role |
|---|---|---|
| Gordon Saxe, MD | University of California, Los Angeles | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States | ||
| University of California, San Diego |
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| ID | Title | Description |
|---|---|---|
| FG000 | Modified Qing Fei Pei Du Tang | encapsulated modified Qing Fei Pai Du Tang mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 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. |
| FG001 | Placebo | Organic brown rice organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Modified Qing Fei Pei Du Tang | encapsulated modified Qing Fei Pai Du Tang mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Total Protein 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, therefore the number of participants in this analysis is different from the total number of participants in the mQFPD or Placebo groups described in the study arms/groups. | Posted | Number | percentage of participants | 14 days |
|
14 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Modified Qing Fei Pei Du Tang | encapsulated modified Qing Fei Pai Du Tang mQFPD: The dosage of mQFPD is 8 capsules three times a day for 14 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ER visit | Gastrointestinal disorders | Non-systematic Assessment | Subject visited ER due to stomach issues |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gordon Saxe, M.D./Ph.D. | Krupp Center for Integrative Research, University of California San Diego | 6195435765 | gsaxe@health.ucsd.edu |
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| 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 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
| organic brown rice | Drug | The dosage of mQFPD is 8 capsules three times a day for 14 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. |
|
| 14 days |
| Adj. 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 |
| Prothrombin Time 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 |
| APTT 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 |
| ESR 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 |
| CRP 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 |
| LDH 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 |
| Albumin |
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 Albumin of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). |
| 14 days |
| Alkaline Phosphatase | 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 Alkaline Phosphatase of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). | 14 days |
| AST | 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 AST of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). | 14 days |
| ALT | 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 ALT of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). | 14 days |
| Total Bilirubin | 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 Total Bilirubin of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). | 14 days |
| 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). | 14 days |
| Prothrombin Time | 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 Prothrombin Time of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). | 14 days |
| 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). | 14 days |
| 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 (international normalized ratio) 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). Higher INR is thought to indicate liver dysfunction. | 14 days |
| 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). | 14 days |
| CRP | 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 CRP of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). | 14 days |
| LDH | 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 LDH of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). | 14 days |
| 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. | 14 days |
| 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) by summing the total symptom severities for those symptoms. Higher symptom severities indicates a worse outcome. The minimum and maximum were: 0 to 30, respectively. | 14 days |
| San Diego |
| California |
| 92093 |
| United States |
| BG001 | Placebo | Organic brown rice organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Total Protein Normal | Count of Participants | Participants |
|
| Albumin Normal | Count of Participants | Participants |
|
| Alkaline Phosphatase Normal | Count of Participants | Participants |
|
| AST Normal | aspartate aminotransferase | Count of Participants | Participants |
|
| ALT Normal | alanine transaminase | Count of Participants | Participants |
|
| Total Bilirubin Normal | Count of Participants | Participants |
|
| eGFR Normal | estimated glomerular filtration rate | Count of Participants | Participants |
|
| Prothrombin Time Normal | Count of Participants | Participants |
|
| APTT Normal | Activated partial thromboplastin time | APTT values were not available for all subjects. | Count of Participants | Participants |
|
| ESR Normal | Erythrocyte sedimentation rate | Count of Participants | Participants |
|
| CRP Normal | C-Reactive Protein | CRP values were not available for all participants. | Count of Participants | Participants |
|
| LDH Normal | Lactate dehydrogenase | Count of Participants | Participants |
|
| OG001 | Placebo | Organic brown rice organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 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. |
|
|
|
| Primary | Albumin 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, therefore the number of participants in this analysis is different from the total number of participants in the mQFPD or Placebo groups described in the study arms/groups. | Posted | Number | percentage of participants | 14 days |
|
|
|
|
| Primary | Alkaline Phosphatase 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. | Chi-square statistic could not be computed because all participants who were normal at baseline were also normal at day 14. 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 mQFPD or Placebo groups described in the study arms/groups. | Posted | Number | percentage of participants | 14 days |
|
|
|
| Primary | AST 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, therefore the number of participants in this analysis is different from the total number of participants in the mQFPD or Placebo groups described in the study arms/groups. | Posted | Number | percentage of participants | 14 days |
|
|
|
|
| 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, therefore the number of participants in this analysis is different from the total number of participants in the mQFPD or Placebo groups described in the study arms/groups. | Posted | Number | percentage of participants | 14 days |
|
|
|
|
| Primary | Bilirubin 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. | Chi-square statistic could not be computed because all participants who were normal at baseline were also normal at day 14. 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 mQFPD or Placebo groups described in the study arms/groups. | Posted | Number | percentage of participants | 14 days |
|
|
|
| Primary | Adj. 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. | 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 mQFPD or Placebo groups described in the study arms/groups. | Posted | Number | percentage of participants | 14 days |
|
|
|
|
| Primary | Prothrombin Time 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, therefore the number of participants in this analysis is different from the total number of participants in the mQFPD or Placebo groups described in the study arms/groups. | Posted | Number | percentage of participants | 14 days |
|
|
|
|
| Primary | APTT 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, therefore the number of participants in this analysis is different from the total number of participants in the mQFPD or Placebo groups described in the study arms/groups. | Posted | Number | percentage of participants | 14 days |
|
|
|
|
| Primary | ESR 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. | Chi-square statistic could not be computed because all participants who were normal at baseline were also normal at day 14. 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 mQFPD or Placebo groups described in the study arms/groups. | Posted | Number | percentage of participants | 14 days |
|
|
|
| Primary | CRP 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. 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 mQFPD or Placebo groups described in the study arms/groups. | Posted | Number | percentage of participants | 14 days |
|
|
|
|
| Primary | LDH 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, therefore the number of participants in this analysis is different from the total number of participants in the mQFPD or Placebo groups described in the study arms/groups. | Posted | Number | percentage of participants | 14 days |
|
|
|
|
| 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, 7 and 14. | Posted | Mean | Standard Deviation | copies per mL | 14 days |
|
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|
|
| Secondary | Albumin | 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 Albumin of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). | Posted | Mean | Standard Deviation | U/L | 14 days |
|
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|
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| Secondary | Alkaline Phosphatase | 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 Alkaline Phosphatase of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). | Posted | Mean | Standard Deviation | U/L | 14 days |
|
|
|
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| Secondary | AST | 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 AST of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). | Posted | Mean | Standard Deviation | U/L | 14 days |
|
|
|
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| Secondary | ALT | 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 ALT of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). | Posted | Mean | Standard Deviation | U/L | 14 days |
|
|
|
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| Secondary | Total Bilirubin | 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 Total Bilirubin of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). | Posted | Mean | Standard Deviation | mg/dL | 14 days |
|
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| 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). | Posted | Mean | Standard Deviation | mL/min | 14 days |
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| Secondary | Prothrombin Time | 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 Prothrombin Time of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). | Posted | Mean | Standard Deviation | sec | 14 days |
|
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| 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). | Posted | Mean | Standard Deviation | sec | 14 days |
|
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|
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| 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 (international normalized ratio) 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). Higher INR is thought to indicate liver dysfunction. | Posted | Mean | Standard Deviation | ratio | 14 days |
|
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|
|
| 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). | Posted | Mean | Standard Deviation | mm/hr | 14 days |
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| Secondary | CRP | 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 CRP of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). | Posted | Mean | Standard Deviation | mg/dL | 14 days |
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| Secondary | LDH | 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 LDH of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). | Posted | Mean | Standard Deviation | U/L | 14 days |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Total Number of Symptoms | 14 days |
|
|
|
|
| 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) by summing the total symptom severities for those symptoms. Higher symptom severities indicates a worse outcome. The minimum and maximum were: 0 to 30, respectively. | Posted | Mean | Standard Deviation | units on a scale | 14 days |
|
|
|
|
| 0 |
| 24 |
| 2 |
| 24 |
| 0 |
| 24 |
| EG001 | Placebo | Organic brown rice organic brown rice: The dosage of mQFPD is 8 capsules three times a day for 14 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. | 0 | 23 | 0 | 23 | 0 | 23 |
|
| ER Visit | General disorders | Non-systematic Assessment | Headache (migraine) |
|
Not provided
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Day 14 |
|
Degrees of freedom: 1,23 |
| <0.001 |
| F Ratio |
| 13.897 |
| 2-Sided |
| Superiority |
| day 0 to day 14 for the Placebo Group were examined. | ANOVA | degrees of freedom: 1,20 | 0.529 | F ratio | 0.410 | 2-Sided | Superiority |
| Day 2 |
|
| Day 3 |
|
| Day 4 |
|
| Day 5 |
|
| Day 6 |
|
| Day 7 |
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| Day 8 |
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| Day 9 |
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| Day 10 |
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| Day 11 |
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| Day 12 |
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| Day 13 |
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| Day 14 |
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| Day 2 |
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| Day 3 |
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| Day 4 |
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| Day 5 |
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| Day 6 |
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| Day 7 |
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| Day 8 |
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| Day 9 |
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| Day 10 |
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| Day 11 |
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| Day 12 |
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| Day 13 |
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| Day 14 |
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