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

Cancer Clinical Trial

Official title:

A Phase II Randomized Double-Blind Placebo-Controlled Clinical Trial Of Hydroxychloroquine For Prophylaxis Against Covid-19 In Patients Receiving Radiotherapy (COVID)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04381988
• Other study ID #: 20-176
• Status: Terminated
• Phase: Phase 2
• Start date: May 7, 2020
• Est. completion date: April 21, 2021

Study information

• Verified date: April 2021
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: April 21, 2021
• Est. primary completion date: April 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• COVID-19

Intervention

Drug:
• Hydroxychloroquine
400mg daily

Other:
• Placebo
400mg daily

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

Locations

Country	Name	City	State
United States	Memoral Sloan Kettering Basking Ridge (All Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack (All Protocol Activities)	Commack	New York
United States	Memoral Sloan Kettering Westchester (All protocol activities)	Harrison	New York
United States	Memoral Sloan Kettering Monmouth (All protocol activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (All protocol Activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (All Protocol Activities)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cumulative Incidence of Severe COVID-19 or Death	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.	within 12 weeks of randomization

External Links

•   Memorial Sloan Kettering Cancer Center