Chinese Herbal Medicine for COVID-19

(MACH19 Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a 21-herb formula called modified Qing Fei Pai Du Tang (mQFPD) to determine its safety and feasibility for treating mild-to-moderate COVID-19 symptoms. Participants will be randomly assigned to receive either the herbal formula or a placebo made from organic brown rice. The trial aims to compare the herbal treatment to the placebo in individuals managing their symptoms at home. Those who tested positive for COVID-19 within the last 72 hours or began experiencing symptoms up to 9 days ago may be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

You may need to stop taking certain medications to participate in this trial. The trial excludes people using specific drugs like systemic corticosteroids, digoxin, and several others. It's best to discuss your current medications with the study team to see if you qualify.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that Qingfei Paidu Decoction (QFPD), similar to the modified Qing Fei Pai Du Tang (mQFPD) being tested, is generally safe. Studies have not linked QFPD to any serious side effects, and users have not reported severe negative reactions. This suggests that mQFPD might also be safe for use.

The trial aims to test mQFPD for safety and practicality. As this is an early trial phase, the primary goal is to ensure the treatment's safety for participants. This phase typically involves a small group to confirm the treatment does not cause harm. Although the trial is ongoing, the absence of serious side effects in similar treatments is encouraging. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about modified Qing Fei Pei Du Tang (mQFPD) because it offers a herbal approach to treating COVID-19, setting it apart from the standard antiviral and anti-inflammatory medications like remdesivir and dexamethasone. Unlike these conventional treatments, mQFPD is derived from traditional Chinese herbal medicine, which has a long history of use for respiratory illnesses. This encapsulated formula aims to boost the body's natural immune response and potentially reduce inflammation, providing a unique and natural way to combat the virus. The novelty of using a traditional herbal remedy in a modern context is what piques researchers' interest.

What evidence suggests that mQFPD might be an effective treatment for COVID-19?

Research has shown that Qingfei Paidu Decoction (QFPD), a herbal formula similar to modified Qing Fei Pai Du Tang (mQFPD), may help treat COVID-19. Studies have found that QFPD can speed up recovery and improve lung health in COVID-19 patients. It might also reduce the risk of severe illness. Additionally, those using QFPD had a lower COVID-19 related death rate of 1.2% compared to 4.8% in those not using it. In this trial, participants will receive either mQFPD or a placebo. These findings suggest that mQFPD could effectively treat mild-to-moderate COVID-19 symptoms. ^{1 2 3 4 5}

Who Is on the Research Team?

Gordon Saxe, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04939415

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

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8510827/

Efficacy of Qingfei Paidu Decoction on Patients with COVID ... QPD may reduce the risk of death in patients with COVID-19. Further randomized controlled clinical trials are needed to corroborate these findings and provide ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9616618/

Effectiveness and safety research of Qingfei Paidu (QFPD) in ... QFPD could not only significantly improve the cure rate and lung CT of COVID-19, reduce the number of patients turning to critical condition and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0944711321000738

Association between use of Qingfei Paidu Tang and ... The COVID-19 related mortality was 1.2% (95% confidence interval [CI] 0.8% to 1.7%) among the patients receiving QPT and 4.8% (95% CI 4.3% to 5.3%) among those ...

5. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2021.688857/full

Efficacy and Safety of Qingfei Paidu Decoction for Treating ... The results showed that for patients with COVID-19, QFPD combined with conventional treatment was probably better than conventional treatment ...