A Study of Hydroxychloroquine vs Placebo to Prevent COVID-19 Infection in Patients Receiving Radiotherapy

STATUS

Recruiting
participants needed

132
sponsor

Memorial Sloan Kettering Cancer Center

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Updated on 19 February 2024

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cancer

breast cancer

lung cancer

skin cancer

dyspnea

diarrhea

gastrointestinal cancer

chest tightness

cough

systemic therapy

pharyngitis

covid-19

chills

SARS

nervous

hydroxychloroquine

sore throat

antigen test

cns tumor

serologic test

ache

anosmia

nervous system

throat

acute respiratory syndrome (sars)

prostate cancer

cns neoplasms

Summary

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.

Details

Condition	Cancer, Covid 19
Age	18-100 years
Treatment	Placebo, Hydroxychloroquine, Radiation Therapy
Clinical Study Identifier	NCT04381988
Sponsor	Memorial Sloan Kettering Cancer Center
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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

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A Study of Hydroxychloroquine vs Placebo to Prevent COVID-19 Infection in Patients Receiving Radiotherapy