Clinical trial NCT04939415: Chinese Herbal Formula for COVID-19
Official title: Multicenter Double Blind, Placebo Controlled RCT of Modified Qing Fei Pai Du Tang (mQFPD) for COVID-19
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Covid19
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

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:

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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 2 months
measure: Feasibility of the intervention
timeFrame: 2 months
Secondary outcomes:
measure: Duration of viral illness
timeFrame: 6 months
measure: Hospitalization rate
timeFrame: 6 months
measure: ICU admission rate
timeFrame: 6 months
measure: Ventilatory requirement
timeFrame: 6 months
measure: Lymphocyte count
timeFrame: 6 months
measure: Neutrophil count
timeFrame: 6 months
measure: Ferritin
timeFrame: 6 months
measure: D-dimer
timeFrame: 6 months
measure: Lactate dehydrogenase
timeFrame: 6 months
measure: C-reactive protein
timeFrame: 6 months
measure: Troponin
timeFrame: 6 months
measure: Mid-turbinate SARS CoV-2 viral load
timeFrame: 14 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Gordon Saxe, MD
role: STUDY_CHAIR
References: