This is a multi-center, randomized, double-blind, placebo-controlled clinical trial toevaluate a 21-herb formula named modified Qing Fei Pai Du Tang (mQFPD) to treatCOVID-19-positive outpatients with mild-to-moderate symptoms assigned to self-quarantinedand home management. This the study aims to establish the safety and feasibility of theuse of mQFPD vs placebo in 66 total subjects. Subsequent trials will evaluate othertherapeutics as well as the efficacy of mQFPD in a larger study population.
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.
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.
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.
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
University of California, Los Angeles
Los Angeles, California, United States
University of California, San Diego
San Diego, California, United States
Gordon Saxe, MD, Study Chair
University of California, Los Angeles