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Completed

NCT Number: NCT04939415

RCT of Modified Qing Fei Pai Du Tang (mQFPD) for COVID-19

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, Los Angeles, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Total Protein Normal to Abnormal Transition

    Time frame: 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.

  2. Albumin Normal to Abnormal Transition

    Time frame: 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.

  3. Alkaline Phosphatase Normal to Abnormal Transition

    Time frame: 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.

  4. AST Normal to Abnormal Transition

    Time frame: 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.

  5. ALT Normal to Abnormal Transition

    Time frame: 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.

  6. Bilirubin Normal to Abnormal Transition

    Time frame: 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.

  7. Adj. EGFR Normal to Abnormal Transition

    Time frame: 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.

  8. Prothrombin Time Normal to Abnormal Transition

    Time frame: 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.

  9. APTT Normal to Abnormal Transition

    Time frame: 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.

  10. ESR Normal to Abnormal Transition

    Time frame: 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.

  11. CRP Normal to Abnormal Transition

    Time frame: 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.

  12. LDH Normal to Abnormal Transition

    Time frame: 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 outcomes

  1. Mid-turbinate SARS CoV-2 Viral Load

    Time frame: 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.

  2. Albumin

    Time frame: 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).

  3. Alkaline Phosphatase

    Time frame: 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).

  4. AST

    Time frame: 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).

  5. ALT

    Time frame: 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).

  6. Total Bilirubin

    Time frame: 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).

  7. Adj. EGFR

    Time frame: 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).

  8. Prothrombin Time

    Time frame: 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).

  9. APTT

    Time frame: 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).

  10. INR

    Time frame: 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.

  11. ESR

    Time frame: 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).

  12. CRP

    Time frame: 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).

  13. LDH

    Time frame: 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).

  14. Symptom Count

    Time frame: 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.

  15. Symptom Severities

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Acronym: MACH19

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 25, 2021
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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