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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Terminated

Phase 2

Conditions

COVID-19

Cancer

Treatments

Other: Placebo

Radiation: Radiation therapy

Drug: Hydroxychloroquine

Study type

Interventional

Funder types

Other

Identifiers

NCT04381988

20-176

Details and patient eligibility

About

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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.