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This is a prospective, double-blind, randomized, placebo-controlled study in two distinct cohorts to evaluate the efficacy and safety of hydroxychloroquine in the prevention of COVID-19 infection.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria:
Inclusion Criteria Cohort A:
≥ 18 years old
Employee of healthcare organization in South Dakota or Sanford Health employee in any location and with exposure to a person with COVID-19 within the last 5 days
No current symptoms attributable to COVID-19, per HCW report (fever, cough, difficulty breathing, sore throat)
No prior COVID-19 positive diagnosis (eligible if previous testing is negative and meets all other inclusion and exclusion)
Ability to provide informed consent
Inclusion Criteria - Cohort B
≥ 18 years old
High-risk person who had close contact (i.e. within 6 feet for at least 15 minutes) with a COVID-19 positive person within the last 5 days and is a South Dakota resident or high-risk person with close household contact of a COVID-19 positive Sanford employee
High-risk person defined by:
Age 18-44 with 2 or more comorbidities listed below
Age 45-79 with any comorbid condition listed below
Age 80 and above (regardless of comorbid conditions)
Co-morbid list
No current symptoms attributable to COVID-19
No prior COVID-19 positive diagnosis (eligible if previous testing is negative and meets all other inclusion and exclusion)
Ability to provide informed consent
Confirmed review of concomitant medications (with emphasis on cardiac medications)
Exclusion Criteria Cohort A & B:
Primary purpose
Allocation
Interventional model
Masking
1 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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