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Chinese Herbal Formula for COVID-19 (MACH19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04939415
Recruitment Status : Active, not recruiting
First Posted : June 25, 2021
Last Update Posted : February 2, 2022
Sponsor:
Information provided by (Responsible Party):
Gordon Saxe, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: mQFPD Drug: organic brown rice Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter Double Blind, Placebo Controlled RCT of Modified Qing Fei Pai Du Tang (mQFPD) for COVID-19
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: modified Qing Fei Pei Du Tang
encapsulated modified Qing Fei Pai Du Tang
Drug: 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.

Placebo Comparator: Placebo
Organic brown rice
Drug: 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 Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 2 months ]
    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. Feasibility of the intervention [ Time Frame: 2 months ]
    With the primary outcomes focusing on determination of the rates of recruitment and completion


Secondary Outcome Measures :
  1. Duration of viral illness [ Time Frame: 6 months ]
    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)

  2. Hospitalization rate [ Time Frame: 6 months ]
    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

  3. ICU admission rate [ Time Frame: 6 months ]
    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.

  4. Ventilatory requirement [ Time Frame: 6 months ]
    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.

  5. Lymphocyte count [ Time Frame: 6 months ]
    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. Neutrophil count [ Time Frame: 6 months ]
    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).

  7. Ferritin [ Time Frame: 6 months ]
    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).

  8. D-dimer [ Time Frame: 6 months ]
    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).

  9. Lactate dehydrogenase [ Time Frame: 6 months ]
    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).

  10. C-reactive protein [ Time Frame: 6 months ]
    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).

  11. Troponin [ Time Frame: 6 months ]
    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).

  12. 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, 4, 7 and 14.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04939415


Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
University of California, San Diego
San Diego, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Investigators
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Study Chair: Gordon Saxe, MD University of California, Los Angeles
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Responsible Party: Gordon Saxe, Director, Krupp Center for Integrative Research, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04939415    
Other Study ID Numbers: 200633-1b
First Posted: June 25, 2021    Key Record Dates
Last Update Posted: February 2, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases