Cancer, COVID-19
Conditions
Keywords
Hydroxychloroquine, Radiotherapy, 20-176
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.
Interventions
DRUGHydroxychloroquine
400mg daily
OTHERPlacebo
400mg daily
RADIATIONRadiation therapy
Standard radiation therapy will be prescribed and administered as per the patient's radiation oncologist.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
This is a randomized (1:1), double-blind, placebo-controlled phase II clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Incidence of SARS-CoV-2 Infection | 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
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Incidence of Severe COVID-19 or Death | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hydroxychloroquine Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of hydroxychloroquine 400mg daily.
Hydroxychloroquine: 400mg daily
Radiation therapy: Standard radiation therapy will be prescribed and administered as per the patient's radiation oncologist. | 4 |
| Placebo Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of placebo 400mg daily.
Placebo: 400mg daily
Radiation therapy: Standard radiation therapy will be prescribed and administered as per the patient's radiation oncologist. | 0 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | The study was terminated | 4 | 0 |
Baseline characteristics
| Characteristic | Hydroxychloroquine | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 63 years | 63 years | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 4 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 4 Participants | 0 Participants |
| Region of Enrollment United States | 4 Participants | 4 Participants | 0 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 0 |
| other Total, other adverse events | 0 / 4 | 0 / 0 |
| serious Total, serious adverse events | 0 / 4 | 0 / 0 |
Outcome results
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.
Time frame: within 9 weeks from randomization
Population: Data were not collected.
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.
Time frame: within 12 weeks of randomization
Population: Data were not collected