A Study of Hydroxychloroquine vs Placebo to Prevent COVID-19 Infection in Patients Receiving Radiotherapy
NCT ID: NCT04381988
Last Updated: 2021-10-27
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
4 participants
INTERVENTIONAL
2020-05-07
2021-04-21
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Hydroxychloroquine
Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of hydroxychloroquine 400mg daily.
Hydroxychloroquine
400mg daily
Radiation therapy
Standard radiation therapy will be prescribed and administered as per the patient's radiation oncologist.
Placebo
Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of placebo 400mg daily.
Placebo
400mg daily
Radiation therapy
Standard radiation therapy will be prescribed and administered as per the patient's radiation oncologist.
Interventions
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Hydroxychloroquine
400mg daily
Placebo
400mg daily
Radiation therapy
Standard radiation therapy will be prescribed and administered as per the patient's radiation oncologist.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 serology test for SARS-CoV-2
* 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.
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Nancy Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memoral Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States
Memoral Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (All protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Commack (All Protocol Activities)
Commack, New York, United States
Memoral Sloan Kettering Westchester (All protocol activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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20-176
Identifier Type: -
Identifier Source: org_study_id