A Study of Hydroxychloroquine vs Placebo to Prevent COVID-19 Infection in Patients Receiving Radiotherapy
Condition: COVID-19; Cancer
MeSH terms: COVID-19
Intervention: Hydroxychloroquine; Placebo; Radiation therapy
Intervention description: 400mg daily; 400mg daily; Standard radiation therapy will be prescribed and administered as per the patient's radiation oncologist.
Intervention MeSH terms: Hydroxychloroquine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized (1:1), double-blind, placebo-controlled phase II clinical trial.
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hydroxychloroquine; Radiotherapy; 20-176

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.