A Phase II Randomized Double-Blind Placebo-Controlled Clinical Trial Of Hydroxychloroquine For Prophylaxis Against Covid-19 In Patients Receiving Radiotherapy (COVID)
Overview
- Phase
- Phase 2
- Intervention
- Hydroxychloroquine
- Conditions
- COVID-19
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 4
- Locations
- 7
- Primary Endpoint
- Cumulative Incidence of SARS-CoV-2 Infection
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
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
Arms & Interventions
Hydroxychloroquine
Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of hydroxychloroquine 400mg daily.
Intervention: Hydroxychloroquine
Hydroxychloroquine
Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of hydroxychloroquine 400mg daily.
Intervention: Radiation therapy
Placebo
Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of placebo 400mg daily.
Intervention: Placebo
Placebo
Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of placebo 400mg daily.
Intervention: Radiation therapy
Outcomes
Primary Outcomes
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 Outcomes
- Cumulative Incidence of Severe COVID-19 or Death(within 12 weeks of randomization)