A Study of Hydroxychloroquine vs Placebo to Prevent COVID-19 Infection in Patients Receiving Radiotherapy
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 27, 2021 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Prevention
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Interventions being studied
- Drug: Hydroxychloroquine; Other: Placebo; Radiation: Radiation therapy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- Previous positive test for SARS-CoV-2
- Previous positive serology test for SARS-CoV-2
- Recent Chest CT meeting CT
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Memoral Sloan Kettering Basking Ridge (All Protocol Activities)Basking Ridge, New Jersey
- Memoral Sloan Kettering Monmouth (All protocol activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (All protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Commack (All Protocol Activities)Commack, New York
- Memoral Sloan Kettering Westchester (All protocol activities)Harrison, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, New York
- Memorial Sloan Kettering Nassau (All Protocol Activities)Uniondale, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 27, 2021. Always confirm current availability with the study team.