Chinese Herbal Formula for COVID-19

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multicenter Double Blind, Placebo Controlled RCT of Modified Qing Fei Pai Du Tang (mQFPD) for COVID-19

Conditions
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Covid19

Intervention / Treatment
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* Drug: mQFPD
* Drug: organic brown rice


Participation Criteria
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Eligibility Criteria
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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: Any of the following symptoms which, according to the CDC, require hospitalization: Trouble breathing Persistent pain or pressure in the chest New confusion or inability to arouse 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) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: modified Qing Fei Pei Du Tang<br>encapsulated modified Qing Fei Pai Du Tang | Drug: mQFPD<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Organic brown rice | Drug: organic brown rice<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Quantitative monitoring of SARS-CoV-2 shedding in order to detect early potential increases in SARS-CoV-2 viral load during treatment. The safety of the study medication will also be assessed through laboratory data collection at baseline, and at either the end of the treatments. | 2 months | 
| Feasibility of the intervention | With the primary outcomes focusing on determination of the rates of recruitment and completion | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of viral illness | 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 duration of COVID-19 acute viral illness (as measured by fever and self-reported symptom scores) | 6 months | 
| Hospitalization rate | 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 hospitalization rate | 6 months | 
| ICU admission rate | 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 ICU admission rate. | 6 months | 
| Ventilatory requirement | 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 maximum ventilatory requirement during hospitalization, if applicable. | 6 months | 
| Lymphocyte count | 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 lymphocyte count of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). | 6 months | 
| Neutrophil count | 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 neutrophil count of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). | 6 months | 
| Ferritin | 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 ferritin level of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). | 6 months | 
| D-dimer | 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 d-dimer level of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). | 6 months | 
| 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). | 6 months | 
| 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). | 6 months | 
| Troponin | 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 troponin level of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). | 6 months | 
| 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. | 14 days |