Phase 1
Completed N=53
RCT of Modified Qing Fei Pai Du Tang (mQFPD) for COVID-19
Covid19
Source: ClinicalTrials.gov NCT04939415 ↗
Enrolled (actual)
53
Serious AEs
4.3%
Results posted
Sep 2025
Primary outcomePrimary: Total Protein Normal to Abnormal Transition — 4.5; 4.6 percentage of participants — p=1.000
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Protein Normal to Abnormal Transition |
4.5; 4.6 | 1.000 |
| PRIMARY Albumin Normal to Abnormal Transition |
4.5; 0.0 | 1.000 |
| PRIMARY Alkaline Phosphatase Normal to Abnormal Transition |
0; 0 | — |
| PRIMARY AST Normal to Abnormal Transition |
4.8; 0 | 0.488 |
| PRIMARY ALT Normal to Abnormal Transition |
9.5; 0 | 0.488 |
| PRIMARY Bilirubin Normal to Abnormal Transition |
0; 0 | — |
| PRIMARY Adj. EGFR Normal to Abnormal Transition |
15.0; 0 | 0.231 |
| PRIMARY Prothrombin Time Normal to Abnormal Transition |
7.1; 5.6 | 1.000 |
| PRIMARY APTT Normal to Abnormal Transition |
9.5; 12.5 | 1.000 |
| PRIMARY ESR Normal to Abnormal Transition |
0; 0 | — |
| PRIMARY CRP Normal to Abnormal Transition |
0; 8.3 | 0.462 |
| PRIMARY LDH Normal to Abnormal Transition |
50; 41.7 | 1.000 |
| SECONDARY Mid-turbinate SARS CoV-2 Viral Load |
17.9358; 15.5282; 33.9909; 32.7374; 37.5100; 35.8814 | 0.668 |
| SECONDARY Albumin |
4.43; 4.5; 4.49; 4.56 | 0.860 |
| SECONDARY Alkaline Phosphatase |
83.96; 78.83; 79.71; 75.32 | 0.853 |
| SECONDARY AST |
28.54; 21.00; 25.88; 17.91 | 0.995 |
| SECONDARY ALT |
28.46; 23.78; 29.46; 19.41 | 0.266 |
| SECONDARY Total Bilirubin |
0.39; 0.41; 0.52; 0.42 | 0.039 sig |
| SECONDARY Adj. EGFR |
111.25; 117.09; 107.65; 114.16 | 0.710 |
| SECONDARY Prothrombin Time |
11.88; 11.66; 11.9; 11.28 | 0.099 |
| SECONDARY APTT |
32.85; 33.37; 32.24; 32.36 | 0.228 |
| SECONDARY INR |
1.06; 1.1; 1.07; 1.07 | 0.119 |
| SECONDARY ESR |
16.18; 18.80; 12.50; 15.62 | 0.643 |
| SECONDARY CRP |
1.87; 0.88; 1.10; 0.35 | 0.817 |
| SECONDARY LDH |
208.5; 177.48; 210.29; 186.59 | 0.578 |
| SECONDARY Symptom Count |
8.3750; 7.3043; 7.5000; 5.7826; 6.6667; 6.0435 | .643 |
| SECONDARY Symptom Severities |
16.0000; 15.5217; 14.0417; 11.0455; 12.2500; 10.0000 | .159 |
Eligibility 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
- 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 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
Data sourced from ClinicalTrials.gov (NCT04939415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.