Official Title
A Phase II Randomized Double-Blind Placebo-Controlled Clinical Trial Of Hydroxychloroquine For Prophylaxis Against Covid-19 In Patients Receiving Radiotherapy (COVID)
Brief 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.

Recruiting
COVID-19
Cancer

Drug: Hydroxychloroquine
400mg daily
Hydroxychloroquine

Other: Placebo
400mg daily
Placebo

Radiation: Radiation therapy
Standard radiation therapy will be prescribed and administered as per the patient's radiation oncologist.
Hydroxychloroquine
Placebo

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 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
United States
Locations

Memoral Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920

Recruiting

Investigator: Nancy Lee, MD
Contact: 212-639-3341

Memoral Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, 07748

Recruiting

Investigator: Nancy Lee, MD
Contact: 212-639-3341

Memorial Sloan Kettering Bergen (All protocol Activities)
Montvale, New Jersey, 07645

Recruiting

Investigator: Nancy Lee, MD
Contact: 212-639-3341

Memorial Sloan Kettering Commack (All Protocol Activities)
Commack, New York, 11725

Recruiting

Investigator: Nancy Lee, MD
Contact: 212-639-3341

Memoral Sloan Kettering Westchester (All protocol activities)
Harrison, New York, 10604

Recruiting

Investigator: Nancy Lee, MD
Contact: 212-639-3341

Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065

Recruiting

Investigator: Nancy Lee, MD
Contact: 212-639-3341

Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553

Recruiting

Investigator: Nancy Lee, MD
Contact: 212-639-3341

Contacts

Nancy Lee, MD
212-639-3341
leen2@mskcc.org

Yao Yu, MD
908-542-3427

Nancy Lee, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center

Memorial Sloan Kettering Cancer Center
NCT Number
Keywords
hydroxychloroquine
RADIOTHERAPY
20-176
MeSH Terms
Hydroxychloroquine