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

Multicenter Double Blind, Placebo Controlled RCT of Modified Qing Fei Pai Du Tang (mQFPD) for COVID-19

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.

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.

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