Hydroxychloroquine as Post-Exposure Prophylaxis Against COVID-19 Infection
Condition: COVID-19; SARS-CoV 2
MeSH terms: COVID-19
Intervention: Hydroxychloroquine; Vitamin D
Intervention description: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.; Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.
Intervention MeSH terms: Vitamin D; Hydroxychloroquine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

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