Official Title
Randomized, Double-Blind, Controlled Trial of Hydroxychloroquine vs Placebo as Post-Exposure Prophylaxis Against COVID-19 Infection
Brief Summary

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.

Terminated
COVID-19
SARS-CoV 2

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.

Eligibility 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

- 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Sanford Health
Sioux Falls, South Dakota, United States

Susan Hoover, MD, Study Chair
Sanford Health

Sanford Health
NCT Number
MeSH Terms
COVID-19
Vitamin D
Hydroxychloroquine