Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort A: Healthcare worker (hydroxychloroquine)
  • Drug: Hydroxychloroquine
    Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.
Placebo Comparator
Cohort A: Healthcare worker (placebo)
  • Dietary Supplement: Vitamin D
    Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.
Experimental
Cohort B: High-Risk participant (hydroxychloroqine)
  • Drug: Hydroxychloroquine
    Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.
Placebo Comparator
Cohort B: High-Risk participant (placebo)
  • Dietary Supplement: Vitamin D
    Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.

Recruiting Locations

More Details

NCT ID
NCT04372017
Status
Terminated
Sponsor
Sanford Health

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.