Hydroxychloroquine as Post-Exposure Prophylaxis Against COVID-19 Infection
Stopped early · Phase 3 · Has a placebo group
Conditions studied: COVID-19, SARS-CoV 2
In brief
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.
Key facts
- Study ID
- NCT04372017
- Run by
- Sanford Health
- People needed
- 1
- Starts
- 2020-05-14
- Expected to finish
- 2021-06-04
- Last updated by the study team
- 2021-12-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
- Occupational exposure as determined by the participant's employee health department (i.e. not wearing the proper Personal Protective Equipment (PPE))
- Criteria according to Center for Disease Control (CDC) guidelines
- Community exposure (within 6 feet for at least 15 minutes)
- 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
- Congestive Heart Failure (CHF)
- Chronic lung disease (Includes any of the following: asthma, chronic obstructive pulmonary disease, emphysema)
- Solid organ transplant or immunosuppression (Defined as an outpatient prescription of greater than 10 mg/day of prednisone or equivalent, use of chemotherapy, or use of immunosuppressive agents for solid organ transplant or for an autoimmune disease.)
- Chronic Kidney Disease or End Stage Renal Disease
- Diabetes mellitus
- Cardiovascular disease/Hypertension
- Smoking/Vaping (currently using or history of using in the past 1 year)
- Obesity (calculated by height and weight per participant report)
Where it is running
- Sanford Health — Sioux Falls, South Dakota, United States
Full record on ClinicalTrials.gov
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