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

This is an interventional prevention trial for COVID-19 focused on measuring Hydroxychloroquine, Radiotherapy, 20-176 Read More

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.