RCT of Modified Qing Fei Pai Du Tang (mQFPD) for COVID-19 (MACH19)

University of California San Diego

Status and phase

Completed

Phase 1

Conditions

Covid19

Treatments

Drug: organic brown rice

Drug: mQFPD

Study type

Interventional

Funder types

Other

Identifiers

NCT04939415

200633-1b

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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:
1. Trouble breathing
2. Persistent pain or pressure in the chest
3. New confusion or inability to arouse
4. 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
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