The PATCH Trial (Prevention And Treatment of COVID-19 With Hydroxychloroquine)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Time to Release From Quarantine Time
研究概览
简要总结
The PATCH trial (Prevention And Treatment of COVID-19 with Hydroxychloroquine) is funded investigator-initiated trial that includes 3 cohorts. Cohort 1: a double-blind placebo controlled trial of high dose HCQ as a treatment for home bound COVID-19 positive patients; Cohort 2: a randomized study testing different doses of HCQ in hospitalized patients; Cohort 3: a double blind placebo controlled trial of low dose HCQ as a preventative medicine in health care workers.
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)
盲法说明
Cohorts 1 and 3 are double-blind placebo control cohorts. Cohort 2 is an open label randomized study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years old (Sub-studies 2 and 3)
- •Competent and capable to provide informed consent
- •Have access to a smart device such as a cell phone, tablet, laptop computer with necessary data/internet accessibility
- •Subjects meeting the following criteria by Sub-Study
- •Sub-Study 1:
- •Age ≥40 years since the risk of prolonged disease that progresses to severe COVID-19 disease increases with age.
- •PCR-positive for the SARS-CoV2 virus
- •(Fever, and cough, or Fever and shortness of breath,
- •≤4 days since the first symptoms of COVID-19 and date of testing
- •Not taking azithromycin
- •Not requiring hospitalization and is sent home for quarantine.
- •Must live within 30 miles of HUP or Penn Presbytarian Medical Center to facilitate drop-off of medication
- •Must own a working computer, or smartphone and have internet access
- •Must be willing to fill out a daily symptom diary
- •Must be available for a daily phone call,
- •Must take their own temperature twice a day
- •Must be willing to report the observed symptoms and development of COVID-19 in the co-inhabitants of the residence at which the quarantine will be served.
- •Sub-Study 2 Hospitalized non-ICU service patients.
- •PCR-positive for SARS-CoV-2
- •Patients admitted to a floor bed at Hospital of the University of Pennsylvania or Penn Presbyterian.
- •One or more of the following risk factors for progression to severe disease including: immunocompromising conditions, structural lung disease, hypertension, coronary artery disease, diabetes, age > 60, ferritin > 850, CRP > 6, D-dimer > 1000 Sub-Study 3 Health Care Worker Prevention
- •Emergency Medicine or Infectious Disease Team physician or nurse at HUP or PPMC
- •≥20 hours per week of clinical work scheduled in the coming 2 months during the COVID-19 pandemic
- •No fever, cough, or shortness of breath in the past 2 weeks
- •Willing to report compliance with HCQ in the form of a diary
- •Patients must be able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
- •Exclusion Criteria <18 years of age
- •Prisoners or other detained persons
- •Allergy to hydroxychloroquine Pregnant or lactating or positive pregnancy test
- •Receiving any treatment drug for 2019-ncov within 14 days prior to screening evaluation (off label, compassionate use or trial related).
- •Co-enrollment onto another COVID-19 study is not allowed unless there is approval by the Medical Monitor in consultation with the PI and EM and ID sub-I leaders.
- •Known history of retinal disease including but not limited to age related macular degeneration.
- •Taking any of the following medications that prolong Qtc:
- •Chlorpromazine.Haloperidol, Droperidol, Quetiapine, Olanzapine. Amisulpride. Thioridazine
- •History of interstitial lung disease or chronic pneumonitis unrelated COVID-
- •Due to risk of disease exacerbation patients with porphyria or psoriasis are ineligible unless the disease is well controlled and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations.
- •Patients with serious intercurrent illness that requires active infusional therapy, intense monitoring, or frequent dose adjustments for medication including but not limited to infectious disease, cancer, autoimmune disease, cardiovascular disease.
- •Patients who have undergone major abdominal, thoracic, spine or CNS surgery in the last 2 months, or plan to undergo surgery during study participation.
- •Patients receiving cytochrome P450 enzyme-inducing anticonvulsant drugs (i.e. phenytoin, carbamazepine, Phenobarbital, primidone or oxcarbazepine) within 4 weeks of the start of the study treatment
- •History or evidence of increased cardiovascular risk including any of the following:
- •Left ventricular ejection fraction (LVEF) < institutional lower limit of normal. Baseline echocardiogram is not required.
- •A QT interval corrected for heart rate using the Frederica formula > 500 msec (Sub-study 2)
- •Current clinically significant uncontrolled arrhythmias. Exception: Subjects with controlled atrial fibrillation
- •History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to enrollment
- •Current ≥ Class II congestive heart failure as defined by New York Heart Association
排除标准
- 未提供
研究组 & 干预措施
Cohort 1 HCQ
COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with hydroxychloroquine 400 mg twice a day for up to 14 days
干预措施: Hydroxychloroquine Sulfate 400 mg twice a day (Drug)
Cohort 1 Placebo
COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with placebo twice a day for up to 14 days. Crossover is allowed if symptoms worsen after 7 days of treatment.
干预措施: Placebo oral tablet (Drug)
Cohort 2 HCQ high dose
Hospitalized COVID-19 PCR+ patients randomized to this arm will be treated with hydroxychloroquine 600 mg twice a day for up to 14 days
干预措施: Hydroxychloroquine Sulfate 600 mg twice a day (Drug)
Cohort 2 HCQ low dose
Hospitalized COVID-19 PCR+ patients randomized to this arm will be treated with hydroxychloroquine 600 mg once a day for up to 7 days
干预措施: Hydroxychloroquine Sulfate 600 mg once a day (Drug)
Cohort 3 HCQ
Health care workers at high risk of contracting COVID-19 randomized to this arm will be treated with hydroxychloroquine 600 mg once a day for 2 months
干预措施: Hydroxychloroquine Sulfate 600 mg once a day (Drug)
Cohort 3 Placebo
Health care workers at high risk of contracting COVID-19 randomized to this arm will be treated with placebo for 2 month. Crossover is allowed if subject becomes SARS-CoV2 positive.
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Time to Release From Quarantine Time
时间窗: until quarantine release or hospitalization
Cohort 1 (home quarantined COVID-19 patients): Median time to release from quarantine by meeting the following criteria: 1) No fever for 72 hours 2) improvement in other symptoms and 3) 7 or 10 days (depending on CDC guidance at the time) have elapsed since the beginning of symptom onset.
Time to Hospital Discharge
时间窗: until hospital discharge
Cohort 2 (hospitalized COVID-19 patients): median number of days until hospital discharge
Number of Health Care Workers Who Developed SARS-COV-2 Infection
时间窗: 2 months
Cohort 3 Physicians and nurse prophylaxis: Rate of COVID-19 infection at 2 months
次要结局
- Rate of Hospitalization(until quarantine release)
- Rate of Housemate Infection(until quarantine release, or approximately <20 days)
研究者
Ravi Amaravadi, MD
Associate Professor
University of Pennsylvania