Trial Outcomes & Findings for A Study of Hydroxychloroquine vs Placebo to Prevent COVID-19 Infection in Patients Receiving Radiotherapy (NCT NCT04381988)
NCT ID: NCT04381988
Last Updated: 2021-10-27
Results Overview
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.
TERMINATED
PHASE2
4 participants
within 9 weeks from randomization
2021-10-27
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
The study was terminated
|
4
|
0
|
Baseline Characteristics
A Study of Hydroxychloroquine vs Placebo to Prevent COVID-19 Infection in Patients Receiving Radiotherapy
Baseline characteristics by cohort
| Measure |
Hydroxychloroquine
n=4 Participants
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.
|
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.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
—
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 9 weeks from randomizationPopulation: Data were not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: within 12 weeks of randomizationPopulation: Data were not collected
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.
Outcome measures
Outcome data not reported
Adverse Events
Hydroxychloroquine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Nancy Lee, MD
Memorial Sloan Kettering Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place