Status:
TERMINATED
A Study of Hydroxychloroquine vs Placebo to Prevent COVID-19 Infection in Patients Receiving Radiotherapy
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
COVID-19
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04381988
Start Date
May 7 2020
End Date
April 21 2021
Last Update
October 27 2021
Active Locations (7)
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1
Memoral Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
2
Memoral Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (All protocol Activities)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Commack (All Protocol Activities)
Commack, New York, United States, 11725