NCT04381988终止2 期
A Phase II Randomized Double-Blind Placebo-Controlled Clinical Trial Of Hydroxychloroquine For Prophylaxis Against Covid-19 In Patients Receiving Radiotherapy (COVID)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 7
- 主要终点
- Cumulative Incidence of SARS-CoV-2 Infection
研究概览
简要总结
The researchers are doing this study to find out whether the study drug hydroxychloroquine can prevent infection with the COVID-19 virus, compared with placebo, in people who are receiving radiation therapy for their cancer. The placebo used in this study is a tablet that looks the same as the study drug and is taken in the same way, but it does not contain any active ingredients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •For patients who have not started radiation at the time of screening: patients are required to have a plan in place for a minimum of 10 radiation treatments with or without concurrent systemic therapy
- •For patients who have already started radiation at the time of screening: patients must complete enrollment such that they are able to receive at least 10 radiation treatments with hydroxychloroquine.
- •Disease Site
- •Mandatory inclusion criteria:
- •No COVID-19 symptoms within 14 days of enrollment:
- •(Temp >38C in addition to sore throat, cough, wheezing, chest tightness, shortness of breath, body aches, chills, diarrhea, and anosmia)
- •If symptoms are present within 14 days of enrollment, patients with a negative COVID-19 PCR or COVID-19 serology assay are eligible for inclusion.
- •No close contact with confirmed COVID-19 person
- •Close contact defined as:
- •Within 6 feet for prolonged period
- •Cohabitating
- •Optional laboratory criteria (Recommended if available)
- •Negative pre-treatment SARS-CoV-2 rapid antigen test result (within 1 week of enrollment)
- •Negative pre-treatment SARS-CoV-2 PCR test result (within 1 week of enrollment) using MSKCC laboratory or outside laboratory assay
- •Negative pre-treatment Standard Q COVID-19 IgM/IgG rapid serology result (within 1 week of enrollment)
- •Blood serum for SARS-CoV-2 serology tests (being validated by MSKCC)
- •Disease site meets following criteria:
- •Head and Neck / High-Risk Skin Cancer
- •Lung Cancer
- •Breast Cancer
- •Prostate Cancer
- •Central Nervous System Tumors
- •Gastrointestinal System Cancer
- •Gynecologic cancer
- •Other disease sites permitted at PI discretion
排除标准
- •Previous positive test for SARS-CoV-2
- •Previous positive serology test for SARS-CoV-2
- •Recent Chest CT meeting CT exclusion criteria
- •Live in a skilled nursing facility with COVID-19 symptoms (Temp >38 C in addition to sore throat, cough, wheezing, chest tightness, shortness of breath, body aches or chills, diarrhea, anosmia)
- •Known hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives
- •Pre-existing retinopathy
- •Known chronic kidney disease, stage 4 or 5, or receiving dialysis
- •Breast Feeding
- •Tamoxifen
- •Absolute neutrophil Count <1,000/ml at registration
- •Concurrent use of any other quinine derivative
- •Antiarrhythmic medications: amiodarone, sotalol, dofetilide, procainamide, quinidine, flecainide
- •Glucose-6-phosphate dehydrogenase deficiency
- •Pre-treatment corrected QT interval (QTc) ≥470 milliseconds**
- •Prisoners
- •Inability to participate
- •Psoriasis
- •History of suicidal ideation
- •CT Criteria for Enrollment Exclusion (Optional - only for patients who received a diagnostic CT as part of standard of care or a thoracic CT as part of radiation simulation): All patients with COVID-19 typical radiographic findings on CT Chest as defined by the RSNA will be excluded. Patients with any NEW COVID-19 indeterminate radiographic findings on CT Chest that are concerning for COVID-19 will be excluded. COVID-19 indeterminate features are permitted if they can be demonstrated as STABLE on prior (>14 calendar days) CT Chest or PET/CT. If no prior comparison is available AND any intermediate or typical feature is present, the patient is not eligible.
- •COVID-19 Atypical Features
- •Isolated lobar or segmental consolidation without GGO
- •Discrete small nodules (centrilobular, "tree-in-bud")
- •Lung cavitation
- •Smooth interlobular septal thickening with pleural effusion
- •COVID-19 Indeterminate Features
- •Multifocal, diffuse, perihilar, or unilateral GGO with or without consolidation lacking a specific distribution and are non-rounded or non-peripheral
- •Few very small GGO with a non-rounded and non-peripheral distribution
- •COVID-19 Typical Features
- •Peripheral, bilateral GGO with or without consolidation or visible intralobular lines ("crazy paving")
- •Multifocal GGO of rounded morphology with or without consolidation or visible intralobular lines ("crazy paving")
- •Reverse Halo sign or other findings of organizing pneumonia ** If pre-treatment QTC can be decreased to <470, the patient can be re-considered for trial.
研究组 & 干预措施
Hydroxychloroquine
Experimental
Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of hydroxychloroquine 400mg daily.
干预措施: Hydroxychloroquine (Drug)
Hydroxychloroquine
Experimental
Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of hydroxychloroquine 400mg daily.
干预措施: Radiation therapy (Radiation)
Placebo
Placebo Comparator
Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of placebo 400mg daily.
干预措施: Placebo (Other)
Placebo
Placebo Comparator
Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of placebo 400mg daily.
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
Cumulative Incidence of SARS-CoV-2 Infection
时间窗: within 9 weeks from randomization
Any patients who are enrolled and subsequently test positive for SARS-CoV-2 by RT-PCR (outside RT-PCR test results allowed) at any point during the 9 weeks following enrollment will be an event that is considered in the 9-week SARS-CoV-2 infection rate primary endpoint.
次要结局
- Cumulative Incidence of Severe COVID-19 or Death(within 12 weeks of randomization)
研究者
研究点 (7)
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