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

• Status: Terminated
• Trial end date: 2021-04-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Hydroxychloroquine

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.