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Hydroxychloroquine as Post-Exposure Prophylaxis Against COVID-19 Infection

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Sanford Health

Status and phase

Terminated
Phase 3

Conditions

COVID-19
SARS-CoV 2

Treatments

Drug: Hydroxychloroquine
Dietary Supplement: Vitamin D

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1 participants in 4 patient groups, including a placebo group

Cohort A: Healthcare worker (hydroxychloroquine)
Experimental group
Treatment:
Drug: Hydroxychloroquine
Cohort A: Healthcare worker (placebo)
Placebo Comparator group
Treatment:
Dietary Supplement: Vitamin D
Cohort B: High-Risk participant (hydroxychloroqine)
Experimental group
Treatment:
Drug: Hydroxychloroquine
Cohort B: High-Risk participant (placebo)
Placebo Comparator group
Treatment:
Dietary Supplement: Vitamin D

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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