This is a double blind, placebo controlled study in approximately 2,000 health care workers at risk for being exposed to COVID-19. Eligible participants will be randomly assigned (1:1) to either treatment group (HCQ) or placebo in a double-blind fashion. Course of treatment is 30 days.
This is a double blind, placebo controlled study in approximately 2,000 health care workers at risk for being exposed to COVID-19. Eligible participants will be randomly assigned (1:1) to either treatment group (HCQ) or placebo in a double-blind fashion. After enrollment, baseline assessments will include nasopharyngeal swab for COVID-19 and a blood sample to detect seroconversion to COVID-19. For convenience, follow-up will be performed weekly through a direct to participant portal. A call center will provide support for any missed visits. Follow-up includes screening for any COVID-19 clinical infections, other respiratory infections, clinical events, adverse events, and Quality of Life (QoL) assessments. Course of treatment is 30 days. Participants are followed via survey weekly. At the end of treatment participants will return for repeat nasopharyngeal swab for COVID-19 and a blood sample to detect seroconversion to COVID-19. There will be one last contact at 8 weeks (2 months) from baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,360
oral self administered tablet
oral self administered tablet
Number of Participants With Clinical Infection With COVID-19 Infection
This measure was a combination of confirmed infection and suspected infection. Confirmed clinical infection was defined as new-onset of fever or cough or dyspnea AND confirmed COVID-19 positive test result via local PCRI testing. Suspected infection was defined as new-onset fever or cough or dyspnea without local PCR testing due to local restrictions and/or testing policies.
Time frame: 30 days
Number of Participants With COVID-19 Viral Shedding
Number of participants with COVID-19 infection shedding via Covance swab PCR testing
Time frame: 30 days
Number of Participants With Serious Adverse Events (SAEs) or Hydroxychloroquine-Associated Events of Special Interest (EOSIs)
Safety and Tolerability as determined by subject reported serious adverse events (SAEs) and hydroxychloroquine-associated events of special interest. EOSIs include: arrhythmias (ventricular), hepatic failure, bone marrow failure, aplastic anemia, prolonged QT interval, angioedema, dermatitis exfoliative, acute generalized exanthematous pustulosis, psychosis, suicidal ideation, seizure, methemoglobinemia.
Time frame: 30 days
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Children's Hospital Colorado/University of Colorado Denver
Aurora, Colorado, United States
University of Florida
Gainesville, Florida, United States
University of Florida Jacksonville
Jacksonville, Florida, United States
University of Florida Health Central Florida
Leesburg, Florida, United States
University of Miami Florida
Miami, Florida, United States
Advent Health
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
Northwestern Medicine
Chicago, Illinois, United States
Rush University
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
...and 24 more locations