Multicenter Double Blind, Placebo Controlled RCT of Modified Qing Fei Pai Du Tang (mQFPD) for COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Total Protein Normal to Abnormal Transition
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
modified Qing Fei Pei Du Tang
encapsulated modified Qing Fei Pai Du Tang
干预措施: mQFPD (Drug)
Placebo
Organic brown rice
干预措施: organic brown rice (Drug)
结局指标
主要结局
Total Protein Normal to Abnormal Transition
时间窗: 14 days
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Albumin Normal to Abnormal Transition
时间窗: 14 days
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Alkaline Phosphatase Normal to Abnormal Transition
时间窗: 14 days
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
AST Normal to Abnormal Transition
时间窗: 14 days
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
ALT Normal to Abnormal Transition
时间窗: 14 days
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Bilirubin Normal to Abnormal Transition
时间窗: 14 days
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Adj. EGFR Normal to Abnormal Transition
时间窗: 14 days
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Prothrombin Time Normal to Abnormal Transition
时间窗: 14 days
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
APTT Normal to Abnormal Transition
时间窗: 14 days
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
ESR Normal to Abnormal Transition
时间窗: 14 days
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
CRP Normal to Abnormal Transition
时间窗: 14 days
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
LDH Normal to Abnormal Transition
时间窗: 14 days
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
次要结局
- Mid-turbinate SARS CoV-2 Viral Load(14 days)
- Albumin(14 days)
- Alkaline Phosphatase(14 days)
- AST(14 days)
- ALT(14 days)
- Total Bilirubin(14 days)
- Adj. EGFR(14 days)
- Prothrombin Time(14 days)
- APTT(14 days)
- INR(14 days)
- ESR(14 days)
- CRP(14 days)
- LDH(14 days)
- Symptom Count(14 days)
- Symptom Severities(14 days)
研究者
Gordon Saxe
Director, Krupp Center for Integrative Research
University of California, San Diego