Covid19
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGmQFPD
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.
DRUGorganic 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.
Sponsors
University of California, San Diego
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
No
Inclusion criteria
* Positive COVID-19 diagnosis within the prior 72 hours or within 9 days of symptom onset * 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 try to minimize alcohol, cannabis, and dairy products during the study period.
Exclusion criteria
1. 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 2. Current use of investigational agents to prevent or treat COVID-19 3. Known liver disease (ALT/AST \>3x ULN or diagnosis of cirrhosis) 4. Known renal disease (eGFR \< 60 ml/min) or acute nephritis. 5. Uncontrolled hypertension (SBP\>140 or DBP\>90 while on medications) 6. Allergy to tree nuts 7. Bleeding dyscrasia or on anticoagulation (aspirin and/or clopidogrel is allowed) 8. Pregnant or breastfeeding women 9. Use of Tolbutamide 10. Use of systemic corticosteroids (hydrocortisone, cortisone, prednisolone, betamethasone, methylprednisolone, prednisone, dexamethasone). Inhaled budesonide is to be allowed. 11. Use of digoxin 12. Use of Oxacillin 13. Use of Interferon 14. Use of Vincristine 15. Use of Cyclosporine 16. Use of Amiodarone 17. Patients with a past medical history of epilepsy 18. Use of monoamine oxidase inhibitors (MAOI) 19. Use of Methamphetamine within the prior 30 days 20. Use of Cocaine within the prior 30 days 21. Use of aminoglycosides, carbamazepine, flecainide, lithium, phenytoin, phenobarbital, rifampicin, theophylline and warfarin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Protein Normal to Abnormal Transition | 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. |
| Albumin Normal to Abnormal Transition | 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. |
| Alkaline Phosphatase Normal to Abnormal Transition | 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. |
| AST Normal to Abnormal Transition | 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. |
| ALT Normal to Abnormal Transition | 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. |
| Bilirubin Normal to Abnormal Transition | 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. |
| Adj. EGFR Normal to Abnormal Transition | 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. |
| Prothrombin Time Normal to Abnormal Transition | 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. |
| APTT Normal to Abnormal Transition | 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. |
| ESR Normal to Abnormal Transition | 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. |
| CRP Normal to Abnormal Transition | 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. |
| LDH Normal to Abnormal Transition | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LDH | 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 LDH 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, 7 and 14. |
| 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) 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. |
| 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. |
| Albumin | 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 Albumin of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). |
| Alkaline Phosphatase | 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 Alkaline Phosphatase of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). |
| AST | 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 AST of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). |
| ALT | 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 ALT of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). |
| Total Bilirubin | 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 Total Bilirubin of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). |
| 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). |
| Prothrombin Time | 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 Prothrombin Time 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 (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. |
| 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). |
| CRP | 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 CRP of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| 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. | 23 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Modified Qing Fei Pei Du Tang | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 45.2 years STANDARD_DEVIATION 13.5 | 43.0 years STANDARD_DEVIATION 14 | 44.13 years STANDARD_DEVIATION 13.67 |
| Albumin Normal | 22 Participants | 22 Participants | 44 Participants |
| Alkaline Phosphatase Normal | 23 Participants | 21 Participants | 44 Participants |
| ALT Normal | 21 Participants | 21 Participants | 42 Participants |
| APTT Normal | 21 Participants | 16 Participants | 37 Participants |
| AST Normal | 21 Participants | 22 Participants | 43 Participants |
| CRP Normal | 14 Participants | 12 Participants | 26 Participants |
| eGFR Normal | 20 Participants | 20 Participants | 40 Participants |
| ESR Normal | 11 Participants | 12 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 7 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 16 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| LDH Normal | 10 Participants | 12 Participants | 22 Participants |
| Prothrombin Time Normal | 14 Participants | 18 Participants | 32 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 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 | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 18 Participants | 21 Participants | 39 Participants |
| Region of Enrollment United States | 24 Participants | 23 Participants | 47 Participants |
| Sex: Female, Male Female | 18 Participants | 16 Participants | 34 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 13 Participants |
| Total Bilirubin Normal | 24 Participants | 23 Participants | 47 Participants |
| Total Protein Normal | 22 Participants | 22 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 23 |
| other Total, other adverse events | 0 / 24 | 0 / 23 |
| serious Total, serious adverse events | 2 / 24 | 0 / 23 |
Outcome results
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.
Time frame: 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 mQFPD or Placebo groups described in the study arms/groups.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Qing Fei Pei Du Tang | Adj. EGFR Normal to Abnormal Transition | 15.0 percentage of participants |
| Placebo | Adj. EGFR Normal to Abnormal Transition | 0 percentage of participants |
p-value: 0.231Chi-squared, Corrected
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.
Time frame: 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 mQFPD or Placebo groups described in the study arms/groups.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Qing Fei Pei Du Tang | Albumin Normal to Abnormal Transition | 4.5 percentage of participants |
| Placebo | Albumin Normal to Abnormal Transition | 0.0 percentage of participants |
p-value: 1Chi-squared, Corrected
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.
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.~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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Qing Fei Pei Du Tang | 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
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.
Time frame: 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 mQFPD or Placebo groups described in the study arms/groups.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Qing Fei Pei Du Tang | ALT Normal to Abnormal Transition | 9.5 percentage of participants |
| Placebo | ALT Normal to Abnormal Transition | 0 percentage of participants |
p-value: 0.488Chi-squared, Corrected
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.
Time frame: 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 mQFPD or Placebo groups described in the study arms/groups.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Qing Fei Pei Du Tang | APTT Normal to Abnormal Transition | 9.5 percentage of participants |
| Placebo | APTT Normal to Abnormal Transition | 12.5 percentage of participants |
p-value: 1Chi-squared, Corrected
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.
Time frame: 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 mQFPD or Placebo groups described in the study arms/groups.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Qing Fei Pei Du Tang | AST Normal to Abnormal Transition | 4.8 percentage of participants |
| Placebo | AST Normal to Abnormal Transition | 0 percentage of participants |
p-value: 0.488Chi-squared, Corrected
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.
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.~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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Qing Fei Pei Du Tang | 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
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.
Time frame: 14 days
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Qing Fei Pei Du Tang | CRP Normal to Abnormal Transition | 0 percentage of participants |
| Placebo | CRP Normal to Abnormal Transition | 8.3 percentage of participants |
p-value: 0.462Chi-squared, Corrected
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.
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.~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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Qing Fei Pei Du Tang | ESR Normal to Abnormal Transition | 0 percentage of participants |
| Placebo | ESR Normal to Abnormal Transition | 0 percentage of participants |
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.
Time frame: 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 mQFPD or Placebo groups described in the study arms/groups.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Qing Fei Pei Du Tang | LDH Normal to Abnormal Transition | 50 percentage of participants |
| Placebo | LDH Normal to Abnormal Transition | 41.7 percentage of participants |
p-value: 1Chi-squared, Corrected
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.
Time frame: 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 mQFPD or Placebo groups described in the study arms/groups.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Qing Fei Pei Du Tang | Prothrombin Time Normal to Abnormal Transition | 7.1 percentage of participants |
| Placebo | Prothrombin Time Normal to Abnormal Transition | 5.6 percentage of participants |
p-value: 1Chi-squared, Corrected
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.
Time frame: 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 mQFPD or Placebo groups described in the study arms/groups.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Qing Fei Pei Du Tang | Total Protein Normal to Abnormal Transition | 4.5 percentage of participants |
| Placebo | Total Protein Normal to Abnormal Transition | 4.6 percentage of participants |
p-value: 1Chi-squared, Corrected
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 |
|---|---|---|---|---|
| Modified Qing Fei Pei Du Tang | Adj. EGFR | Baseline (Day 1) | 111.25 mL/min | Standard Deviation 24.9 |
| Modified Qing Fei Pei Du Tang | Adj. EGFR | Day 14 | 107.65 mL/min | Standard Deviation 22.82 |
| Placebo | Adj. EGFR | Baseline (Day 1) | 117.09 mL/min | Standard Deviation 26.97 |
| Placebo | Adj. EGFR | Day 14 | 114.16 mL/min | Standard Deviation 27.72 |
p-value: 0.71Mixed Models Analysis
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).
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Modified Qing Fei Pei Du Tang | Albumin | Baseline (Day 1) | 4.43 U/L | Standard Deviation 0.38 |
| Modified Qing Fei Pei Du Tang | Albumin | Day 14 | 4.49 U/L | Standard Deviation 0.37 |
| Placebo | Albumin | Baseline (Day 1) | 4.5 U/L | Standard Deviation 0.22 |
| Placebo | Albumin | Day 14 | 4.56 U/L | Standard Deviation 0.24 |
p-value: 0.86Mixed Models Analysis
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).
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Modified Qing Fei Pei Du Tang | Alkaline Phosphatase | Baseline (Day 1) | 83.96 U/L | Standard Deviation 52.27 |
| Modified Qing Fei Pei Du Tang | Alkaline Phosphatase | Day 14 | 79.71 U/L | Standard Deviation 26.31 |
| Placebo | Alkaline Phosphatase | Baseline (Day 1) | 78.83 U/L | Standard Deviation 24.03 |
| Placebo | Alkaline Phosphatase | Day 14 | 75.32 U/L | Standard Deviation 21.12 |
p-value: 0.853Mixed Models Analysis
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).
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Modified Qing Fei Pei Du Tang | ALT | Baseline (Day 1) | 28.46 U/L | Standard Deviation 16.64 |
| Modified Qing Fei Pei Du Tang | ALT | Day 14 | 29.46 U/L | Standard Deviation 17.73 |
| Placebo | ALT | Baseline (Day 1) | 23.78 U/L | Standard Deviation 17.18 |
| Placebo | ALT | Day 14 | 19.41 U/L | Standard Deviation 8.38 |
p-value: 0.266Mixed 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 |
|---|---|---|---|---|
| Modified Qing Fei Pei Du Tang | APTT | Baseline (Day 1) | 32.85 sec | Standard Deviation 6.01 |
| Modified Qing Fei Pei Du Tang | APTT | Day 14 | 32.24 sec | Standard Deviation 5.34 |
| Placebo | APTT | Baseline (Day 1) | 33.37 sec | Standard Deviation 2.93 |
| Placebo | APTT | Day 14 | 32.36 sec | Standard Deviation 2.94 |
p-value: 0.228Mixed Models Analysis
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).
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Modified Qing Fei Pei Du Tang | AST | Baseline (Day 1) | 28.54 U/L | Standard Deviation 16.72 |
| Modified Qing Fei Pei Du Tang | AST | Day 14 | 25.88 U/L | Standard Deviation 10.84 |
| Placebo | AST | Baseline (Day 1) | 21.00 U/L | Standard Deviation 7.32 |
| Placebo | AST | Day 14 | 17.91 U/L | Standard Deviation 4.51 |
p-value: 0.995Mixed Models Analysis
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).
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Modified Qing Fei Pei Du Tang | CRP | Baseline (Day 1) | 1.87 mg/dL | Standard Deviation 5.01 |
| Modified Qing Fei Pei Du Tang | CRP | Day 14 | 1.10 mg/dL | Standard Deviation 2.85 |
| Placebo | CRP | Baseline (Day 1) | 0.88 mg/dL | Standard Deviation 1.02 |
| Placebo | CRP | Day 14 | 0.35 mg/dL | Standard Deviation 0.25 |
p-value: 0.817Mixed 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 |
|---|---|---|---|---|
| Modified Qing Fei Pei Du Tang | ESR | Baseline (Day 1) | 16.18 mm/hr | Standard Deviation 11.56 |
| Modified Qing Fei Pei Du Tang | ESR | Day 14 | 12.50 mm/hr | Standard Deviation 9.07 |
| Placebo | ESR | Baseline (Day 1) | 18.80 mm/hr | Standard Deviation 12.89 |
| Placebo | ESR | Day 14 | 15.62 mm/hr | Standard Deviation 17.19 |
p-value: 0.643Mixed 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 (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.
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Modified Qing Fei Pei Du Tang | INR | Baseline (Day 1) | 1.06 ratio | Standard Deviation 0.1 |
| Modified Qing Fei Pei Du Tang | INR | Day 14 | 1.07 ratio | Standard Deviation 0.08 |
| Placebo | INR | Baseline (Day 1) | 1.1 ratio | Standard Deviation 0.11 |
| Placebo | INR | Day 14 | 1.07 ratio | Standard Deviation 0.11 |
p-value: 0.119Mixed Models Analysis
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).
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Modified Qing Fei Pei Du Tang | LDH | Baseline (Day 1) | 208.5 U/L | Standard Deviation 80.95 |
| Modified Qing Fei Pei Du Tang | LDH | Day 14 | 210.29 U/L | Standard Deviation 58.62 |
| Placebo | LDH | Baseline (Day 1) | 177.48 U/L | Standard Deviation 27.8 |
| Placebo | LDH | Day 14 | 186.59 U/L | Standard Deviation 24.68 |
p-value: 0.578Mixed 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, 7 and 14.
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Modified Qing Fei Pei Du Tang | Mid-turbinate SARS CoV-2 Viral Load | Day 7 | 33.9909 copies per mL | Standard Deviation 8.67777 |
| Modified Qing Fei Pei Du Tang | Mid-turbinate SARS CoV-2 Viral Load | Day 14 | 37.5100 copies per mL | Standard Deviation 5.05021 |
| Modified Qing Fei Pei Du Tang | Mid-turbinate SARS CoV-2 Viral Load | Baseline (Day 1) | 17.9358 copies per mL | Standard Deviation 7.07254 |
| Placebo | Mid-turbinate SARS CoV-2 Viral Load | Day 7 | 32.7374 copies per mL | Standard Deviation 8.62281 |
| Placebo | Mid-turbinate SARS CoV-2 Viral Load | Day 14 | 35.8814 copies per mL | Standard Deviation 6.3334 |
| Placebo | Mid-turbinate SARS CoV-2 Viral Load | Baseline (Day 1) | 15.5282 copies per mL | Standard Deviation 6.19859 |
p-value: 0.668Mixed Models Analysis
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).
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Modified Qing Fei Pei Du Tang | Prothrombin Time | Baseline (Day 1) | 11.88 sec | Standard Deviation 1.12 |
| Modified Qing Fei Pei Du Tang | Prothrombin Time | Day 14 | 11.9 sec | Standard Deviation 1.02 |
| Placebo | Prothrombin Time | Baseline (Day 1) | 11.66 sec | Standard Deviation 1.15 |
| Placebo | Prothrombin Time | Day 14 | 11.28 sec | Standard Deviation 1.13 |
p-value: 0.099Mixed 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.
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Modified Qing Fei Pei Du Tang | Symptom Count | Day 11 | 3.2083 Total Number of Symptoms | Standard Deviation 2.35869 |
| Modified Qing Fei Pei Du Tang | Symptom Count | Baseline (Day 0) | 8.3750 Total Number of Symptoms | Standard Deviation 2.01759 |
| Modified Qing Fei Pei Du Tang | Symptom Count | Day 1 | 7.5000 Total Number of Symptoms | Standard Deviation 2.82843 |
| Modified Qing Fei Pei Du Tang | Symptom Count | Day 2 | 6.6667 Total Number of Symptoms | Standard Deviation 2.35292 |
| Modified Qing Fei Pei Du Tang | Symptom Count | Day 3 | 6.3750 Total Number of Symptoms | Standard Deviation 2.65088 |
| Modified Qing Fei Pei Du Tang | Symptom Count | Day 9 | 3.9583 Total Number of Symptoms | Standard Deviation 2.85107 |
| Modified Qing Fei Pei Du Tang | Symptom Count | Day 4 | 5.6667 Total Number of Symptoms | Standard Deviation 2.89928 |
| Modified Qing Fei Pei Du Tang | Symptom Count | Day 5 | 5.3333 Total Number of Symptoms | Standard Deviation 2.85393 |
| Modified Qing Fei Pei Du Tang | Symptom Count | Day 6 | 4.5000 Total Number of Symptoms | Standard Deviation 2.70266 |
| Modified Qing Fei Pei Du Tang | Symptom Count | Day 7 | 4.5000 Total Number of Symptoms | Standard Deviation 2.53669 |
| Modified Qing Fei Pei Du Tang | Symptom Count | Day 8 | 4.0833 Total Number of Symptoms | Standard Deviation 2.73332 |
| Modified Qing Fei Pei Du Tang | Symptom Count | Day 10 | 3.6667 Total Number of Symptoms | Standard Deviation 2.72934 |
| Modified Qing Fei Pei Du Tang | Symptom Count | Day 12 | 2.5417 Total Number of Symptoms | Standard Deviation 2.50181 |
| Modified Qing Fei Pei Du Tang | Symptom Count | Day 13 | 2.6250 Total Number of Symptoms | Standard Deviation 2.46387 |
| Modified Qing Fei Pei Du Tang | Symptom Count | Day 14 | 2.3750 Total Number of Symptoms | Standard Deviation 2.49891 |
| Placebo | Symptom Count | Day 14 | 1.8182 Total Number of Symptoms | Standard Deviation 1.96726 |
| Placebo | Symptom Count | Day 5 | 4.3043 Total Number of Symptoms | Standard Deviation 2.94549 |
| Placebo | Symptom Count | Baseline (Day 0) | 7.3043 Total Number of Symptoms | Standard Deviation 2.49426 |
| Placebo | Symptom Count | Day 11 | 1.9545 Total Number of Symptoms | Standard Deviation 2.05814 |
| Placebo | Symptom Count | Day 6 | 3.9565 Total Number of Symptoms | Standard Deviation 2.93069 |
| Placebo | Symptom Count | Day 2 | 6.0435 Total Number of Symptoms | Standard Deviation 2.24577 |
| Placebo | Symptom Count | Day 13 | 1.6818 Total Number of Symptoms | Standard Deviation 1.83579 |
| Placebo | Symptom Count | Day 4 | 5.1739 Total Number of Symptoms | Standard Deviation 2.53435 |
| Placebo | Symptom Count | Day 8 | 2.9565 Total Number of Symptoms | Standard Deviation 2.63677 |
| Placebo | Symptom Count | Day 7 | 3.3043 Total Number of Symptoms | Standard Deviation 3.0516 |
| Placebo | Symptom Count | Day 9 | 2.6522 Total Number of Symptoms | Standard Deviation 2.44222 |
| Placebo | Symptom Count | Day 10 | 2.3043 Total Number of Symptoms | Standard Deviation 2.26505 |
| Placebo | Symptom Count | Day 1 | 5.7826 Total Number of Symptoms | Standard Deviation 3.19028 |
| Placebo | Symptom Count | Day 3 | 5.6522 Total Number of Symptoms | Standard Deviation 2.32787 |
| Placebo | Symptom Count | Day 12 | 1.6364 Total Number of Symptoms | Standard Deviation 2.03646 |
p-value: 0.643Mixed 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) 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.
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Modified Qing Fei Pei Du Tang | Symptom Severities | Day 14 | 4.0417 units on a scale | Standard Deviation 6.01071 |
| Modified Qing Fei Pei Du Tang | Symptom Severities | Day 5 | 9.1667 units on a scale | Standard Deviation 5.89522 |
| Modified Qing Fei Pei Du Tang | Symptom Severities | Day 8 | 6.3333 units on a scale | Standard Deviation 5.28054 |
| Modified Qing Fei Pei Du Tang | Symptom Severities | Day 6 | 7.5417 units on a scale | Standard Deviation 5.48499 |
| Modified Qing Fei Pei Du Tang | Symptom Severities | Baseline (Day 0) | 16.0000 units on a scale | Standard Deviation 6.13614 |
| Modified Qing Fei Pei Du Tang | Symptom Severities | Day 7 | 7.0417 units on a scale | Standard Deviation 5.05173 |
| Modified Qing Fei Pei Du Tang | Symptom Severities | Day 4 | 10.1667 units on a scale | Standard Deviation 6.58501 |
| Modified Qing Fei Pei Du Tang | Symptom Severities | Day 1 | 14.0417 units on a scale | Standard Deviation 6.81736 |
| Modified Qing Fei Pei Du Tang | Symptom Severities | Day 10 | 5.7917 units on a scale | Standard Deviation 5.70262 |
| Modified Qing Fei Pei Du Tang | Symptom Severities | Day 2 | 12.2500 units on a scale | Standard Deviation 6.26411 |
| Modified Qing Fei Pei Du Tang | Symptom Severities | Day 11 | 5.1667 units on a scale | Standard Deviation 6.23919 |
| Modified Qing Fei Pei Du Tang | Symptom Severities | Day 9 | 6.2500 units on a scale | Standard Deviation 5.7804 |
| Modified Qing Fei Pei Du Tang | Symptom Severities | Day 12 | 4.0000 units on a scale | Standard Deviation 6 |
| Modified Qing Fei Pei Du Tang | Symptom Severities | Day 3 | 11.9583 units on a scale | Standard Deviation 6.86186 |
| Modified Qing Fei Pei Du Tang | Symptom Severities | Day 13 | 4.2083 units on a scale | Standard Deviation 5.51661 |
| Placebo | Symptom Severities | Day 13 | 2.0000 units on a scale | Standard Deviation 2.39046 |
| Placebo | Symptom Severities | Day 8 | 3.9565 units on a scale | Standard Deviation 4.17218 |
| Placebo | Symptom Severities | Day 14 | 2.1364 units on a scale | Standard Deviation 2.41613 |
| Placebo | Symptom Severities | Baseline (Day 0) | 15.5217 units on a scale | Standard Deviation 7.21658 |
| Placebo | Symptom Severities | Day 2 | 10.0000 units on a scale | Standard Deviation 4.98179 |
| Placebo | Symptom Severities | Day 3 | 8.6087 units on a scale | Standard Deviation 4.09811 |
| Placebo | Symptom Severities | Day 4 | 7.7826 units on a scale | Standard Deviation 4.79542 |
| Placebo | Symptom Severities | Day 5 | 6.0000 units on a scale | Standard Deviation 5.03623 |
| Placebo | Symptom Severities | Day 6 | 5.3913 units on a scale | Standard Deviation 4.39772 |
| Placebo | Symptom Severities | Day 7 | 4.6087 units on a scale | Standard Deviation 4.56009 |
| Placebo | Symptom Severities | Day 9 | 3.6522 units on a scale | Standard Deviation 3.9267 |
| Placebo | Symptom Severities | Day 10 | 3.0870 units on a scale | Standard Deviation 3.08829 |
| Placebo | Symptom Severities | Day 11 | 2.4545 units on a scale | Standard Deviation 2.72077 |
| Placebo | Symptom Severities | Day 12 | 1.9545 units on a scale | Standard Deviation 2.57233 |
| Placebo | Symptom Severities | Day 1 | 11.0455 units on a scale | Standard Deviation 6.26766 |
p-value: 0.159Mixed Models Analysis
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).
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Modified Qing Fei Pei Du Tang | Total Bilirubin | Baseline (Day 1) | 0.39 mg/dL | Standard Deviation 0.2 |
| Modified Qing Fei Pei Du Tang | Total Bilirubin | Day 14 | 0.52 mg/dL | Standard Deviation 0.2 |
| Placebo | Total Bilirubin | Baseline (Day 1) | 0.41 mg/dL | Standard Deviation 0.2 |
| Placebo | Total Bilirubin | Day 14 | 0.42 mg/dL | Standard Deviation 0.14 |
p-value: 0.039Mixed Models Analysis
Comparison: day 0 to day 14 for the mQFPD group were examined.p-value: <0.001ANOVA
Comparison: day 0 to day 14 for the Placebo Group were examined.p-value: 0.529ANOVA