Chinese Herbal Medicine for COVID-19

(MACH19 Trial)

Recruiting at 1 trial location

Overseen By Tatyana Shekhtman, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, San Diego

Must not be taking: Corticosteroids, MAOIs, Anticoagulants, others

Disqualifiers: Liver disease, Renal disease, Hypertension, others

Compensation: Varies

Number of Visits: 1

Duration: 2 months

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Gordon Saxe, MD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

Adults over 18 with a recent COVID-19 diagnosis, not severe enough for hospitalization. Participants must be able to track and report their health daily, avoid certain substances like alcohol and dairy, and use contraception if applicable. Those with drug abuse history, severe symptoms or specific medical conditions like kidney disease, uncontrolled hypertension or liver disease are excluded.

Inclusion Criteria

You tested positive for COVID-19 in the last 72 hours or have had symptoms for less than 9 days.

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

Exclusion Criteria

You have used cocaine in the last 30 days.

You have used methamphetamine in the last 30 days.

If you have any of these symptoms and need to go to the hospital: trouble breathing, chest pain, confusion, or blue lips.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Remote screening and consent

Treatment

Participants receive either mQFPD or placebo for COVID-19 treatment

2 months

Blood draws on days 1 and 14, daily diary entries, regular phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

End-of-study laboratory draws via mobile phlebotomy

Treatment Details

Interventions

• mQFPD

Trial Overview The trial is testing the safety of a Chinese herbal formula called modified Qing Fei Pai Du Tang (mQFPD) against placebo in treating mild-to-moderate COVID-19 at home. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real treatment.

Participant Groups

Group I: modified Qing Fei Pei Du Tang Experimental Treatment 1 Intervention

encapsulated modified Qing Fei Pai Du Tang

Group II: Placebo Placebo Group 1 Intervention

Organic brown rice

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+