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.
Drug: Hydroxychloroquine
Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.
Dietary Supplement: Vitamin D
Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.
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
- 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)
- Hyperlipidemia
- 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:
- Known allergy to hydroxychloroquine or quinine
- Known history of long QT syndrome
- Known history of arrhythmia or dysrhythmia
- Known current QTc >500 ms
- Known G6PD deficiency
- Known history of hypoglycemia
- Pregnant or Nursing by patient history
- Use of any of the following concomitant medications: See Appendix D for Exclusion
medication list
- Concurrent diagnosis of dermatitis, porphyria, or psoriasis
- History of chronic liver disease, including cirrhosis and/or diagnosis of hepatitis
(infectious, idiopathic, or immune)
- History of chronic kidney disease
- Pre-existing retinopathy
- Already taking hydroxychloroquine
- Any condition or medication in the opinion of the investigator that would prohibit the
use of hydroxychloroquine
- Enrollment in another clinical with investigational drug or device
- Inability to swallow pills
- Adults unable to provide informed consent
Sanford Health
Sioux Falls, South Dakota, United States
Susan Hoover, MD, Study Chair
Sanford Health