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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04381988
Recruitment Status : Recruiting
First Posted : May 11, 2020
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
COVID-19 Cancer Drug: Hydroxychloroquine Other: Placebo Radiation: Radiation therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized (1:1), double-blind, placebo-controlled phase II clinical trial.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Phase II Randomized Double-Blind Placebo-Controlled Clinical Trial Of Hydroxychloroquine For Prophylaxis Against Covid-19 In Patients Receiving Radiotherapy (COVID)
Actual Study Start Date : May 7, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hydroxychloroquine
Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of hydroxychloroquine 400mg daily.
Drug: Hydroxychloroquine
400mg daily

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

Placebo Comparator: Placebo
Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of placebo 400mg daily.
Other: Placebo
400mg daily

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




Primary Outcome Measures :
  1. cumulative incidence of SARS-CoV-2 infection [ Time Frame: within 9 weeks from randomization ]
    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.


Secondary Outcome Measures :
  1. cumulative incidence of severe COVID-19 or death [ Time Frame: within 12 weeks of randomization ]
    Patients who are positive for SARS-CoV-2 (as defined above) who develop a new oxygen requirement attributable to COVID-19, tachypnea (RR > 20), or those who require hospitalization due to COVID-19 will be considered to have severe COVID-19.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 <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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04381988


Contacts
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Contact: Nancy Lee, MD 212-639-3341 leen2@mskcc.org
Contact: Yao Yu, MD 908-542-3427

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge (All Protocol Activities) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Nancy Lee, MD    212-639-3341      
Memoral Sloan Kettering Monmouth (All protocol activities) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Nancy Lee, MD    212-639-3341      
Memorial Sloan Kettering Bergen (All protocol Activities) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Nancy Lee, MD    212-639-3341      
United States, New York
Memorial Sloan Kettering Commack (All Protocol Activities) Recruiting
Commack, New York, United States, 11725
Contact: Nancy Lee, MD    212-639-3341      
Memoral Sloan Kettering Westchester (All protocol activities) Recruiting
Harrison, New York, United States, 10604
Contact: Nancy Lee, MD    212-639-3341      
Memorial Sloan Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10065
Contact: Nancy Lee, MD    212-639-3341      
Memorial Sloan Kettering Nassau (All Protocol Activities) Recruiting
Uniondale, New York, United States, 11553
Contact: Nancy Lee, MD    212-639-3341      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Nancy Lee, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04381988    
Other Study ID Numbers: 20-176
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Hydroxychloroquine
Radiotherapy
20-176
Additional relevant MeSH terms:
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Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents