Study Stopped
The study was terminated based results of other studies and use of the new vaccine.
A Study of Hydroxychloroquine vs Placebo to Prevent COVID-19 Infection in Patients Receiving Radiotherapy
A Phase II Randomized Double-Blind Placebo-Controlled Clinical Trial Of Hydroxychloroquine For Prophylaxis Against Covid-19 In Patients Receiving Radiotherapy (COVID)
1 other identifier
interventional
4
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 covid19
Started May 2020
Typical duration for phase_2 covid19
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 7, 2020
CompletedFirst Submitted
Initial submission to the registry
May 8, 2020
CompletedFirst Posted
Study publicly available on registry
May 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 21, 2021
CompletedResults Posted
Study results publicly available
October 27, 2021
CompletedOctober 27, 2021
April 1, 2021
12 months
May 8, 2020
October 25, 2021
October 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cumulative Incidence of SARS-CoV-2 Infection
Any patients who are enrolled and subsequently test positive for SARS-CoV-2 by RT-PCR (outside RT-PCR test results allowed) at any point during the 9 weeks following enrollment will be an event that is considered in the 9-week SARS-CoV-2 infection rate primary endpoint.
within 9 weeks from randomization
Secondary Outcomes (1)
Cumulative Incidence of Severe COVID-19 or Death
within 12 weeks of randomization
Study Arms (2)
Hydroxychloroquine
EXPERIMENTALEvery patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of hydroxychloroquine 400mg daily.
Placebo
PLACEBO COMPARATOREvery patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of placebo 400mg daily.
Interventions
Standard radiation therapy will be prescribed and administered as per the patient's radiation oncologist.
Eligibility Criteria
You may qualify if:
- 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
- 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)
- 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)
- +10 more criteria
You may not qualify if:
- Previous positive test for SARS-CoV-2
- Previous positive serology test for SARS-CoV-2
- 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
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memoral Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memoral Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack (All Protocol Activities)
Commack, New York, 11725, United States
Memoral Sloan Kettering Westchester (All protocol activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Nancy Lee, MD
- Organization
- Memorial Sloan Kettering Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy Lee, MD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2020
First Posted
May 11, 2020
Study Start
May 7, 2020
Primary Completion
April 21, 2021
Study Completion
April 21, 2021
Last Updated
October 27, 2021
Results First Posted
October 27, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.