a study of hydroxychloroquine vs placebo to prevent covid-19 infection in patients receiving radiotherapy

Conditions: COVID-19; Cancer

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.


Eligibility criteria:
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.

Keywords: hydroxychloroquine radiotherapy 20-176