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

NCT04939415 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 200633-1b
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (12)

• Total Protein Normal to Abnormal Transition

  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.

  14 days

• Albumin Normal to Abnormal Transition

  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.

  14 days

• Alkaline Phosphatase Normal to Abnormal Transition

  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.

  14 days

• AST Normal to Abnormal Transition

  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.

  14 days

• ALT Normal to Abnormal Transition

  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.

  14 days

• Bilirubin Normal to Abnormal Transition

  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.

  14 days

• Adj. EGFR Normal to Abnormal Transition

  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.

  14 days

• Prothrombin Time Normal to Abnormal Transition

  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.

  14 days

• APTT Normal to Abnormal Transition

  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.

  14 days

• ESR Normal to Abnormal Transition

  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.

  14 days

• CRP Normal to Abnormal Transition

  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.

  14 days

• LDH Normal to Abnormal Transition

  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.

  14 days

Secondary Outcomes (15)

• Mid-turbinate SARS CoV-2 Viral Load

  14 days

• Albumin

  14 days

• Alkaline Phosphatase

  14 days

• AST

  14 days

• ALT

  14 days

Study Arms (2)

modified Qing Fei Pei Du Tang

EXPERIMENTAL

encapsulated modified Qing Fei Pai Du Tang

Drug: mQFPD

Placebo

PLACEBO COMPARATOR

Organic brown rice

Drug: organic brown rice

Interventions

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.

modified Qing Fei Pei Du Tang

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (2)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of California, San Diego

San Diego, California, 92093, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Gordon Saxe, M.D./Ph.D.
• Organization: Krupp Center for Integrative Research, University of California San Diego

gsaxe@health.ucsd.edu

6195435765

Study Officials

• Gordon Saxe, MD

  University of California, Los Angeles

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Krupp Center for Integrative Research

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 25, 2021
• Study Start: July 1, 2021
• Primary Completion: January 27, 2022
• Study Completion: March 13, 2022
• Last Updated: September 5, 2025
• Results First Posted: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)