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Chinese Herbal Formula for COVID-19 (MACH19)

Primary Purpose

Covid19

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
mQFPD
organic brown rice
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Los Angeles
  • University of California, San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

modified Qing Fei Pei Du Tang

Placebo

Arm Description

encapsulated modified Qing Fei Pai Du Tang

Organic brown rice

Outcomes

Primary Outcome Measures

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.
Feasibility of the intervention
With the primary outcomes focusing on determination of the rates of recruitment and completion

Secondary Outcome Measures

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)
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
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.
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.
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).
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).
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).
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).
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).
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).
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).
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.

Full Information

First Posted
June 21, 2021
Last Updated
August 4, 2023
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT04939415
Brief Title
Chinese Herbal Formula for COVID-19
Acronym
MACH19
Official Title
Multicenter Double Blind, Placebo Controlled RCT of Modified Qing Fei Pai Du Tang (mQFPD) for COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
modified Qing Fei Pei Du Tang
Arm Type
Experimental
Arm Description
encapsulated modified Qing Fei Pai Du Tang
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Organic brown rice
Intervention Type
Drug
Intervention Name(s)
mQFPD
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
organic brown rice
Intervention Description
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 Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
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.
Time Frame
2 months
Title
Feasibility of the intervention
Description
With the primary outcomes focusing on determination of the rates of recruitment and completion
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Duration of viral illness
Description
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)
Time Frame
6 months
Title
Hospitalization rate
Description
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
Time Frame
6 months
Title
ICU admission rate
Description
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.
Time Frame
6 months
Title
Ventilatory requirement
Description
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.
Time Frame
6 months
Title
Lymphocyte count
Description
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).
Time Frame
6 months
Title
Neutrophil count
Description
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).
Time Frame
6 months
Title
Ferritin
Description
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).
Time Frame
6 months
Title
D-dimer
Description
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).
Time Frame
6 months
Title
Lactate dehydrogenase
Description
A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the serum Lactate Dehydrogenase level of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).
Time Frame
6 months
Title
C-reactive protein
Description
A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the serum C-Reactive Protein level of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).
Time Frame
6 months
Title
Troponin
Description
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).
Time Frame
6 months
Title
Mid-turbinate SARS CoV-2 viral load
Description
A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by changes in the SARS CoV-2 viral loads among mid-turbinate nasal swabs taken on days 0, 4, 7 and 14.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon Saxe, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Study Chair
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Chinese Herbal Formula for COVID-19

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