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Chinese Herbal Formula for COVID-19

About

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 1

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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 < 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

Join this Trial

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Study Stats
Protocol No.
20-001928
Category
Treatment for Non-Hospitalized Patients
Contact
Andrew Shubov
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04939415
For detailed technical eligibility, visit ClinicalTrials.gov.