A Study of Hydroxychloroquine vs Placebo to Prevent COVID-19 Infection in Patients Receiving Radiotherapy
Purpose
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.
Conditions
- COVID-19
- Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age ≥ 18 - ECOG 0-3 - 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
Exclusion Criteria
- 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This is a randomized (1:1), double-blind, placebo-controlled phase II clinical trial.
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Hydroxychloroquine |
Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of hydroxychloroquine 400mg daily. |
|
Placebo Comparator Placebo |
Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of placebo 400mg daily. |
|
Recruiting Locations
More Details
- NCT ID
- NCT04381988
- Status
- Terminated
- Sponsor
- Memorial Sloan Kettering Cancer Center