Hydroxychloroquine as Post-Exposure Prophylaxis Against COVID-19 Infection

• Status: Terminated
• Trial end date: 2020-06-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sanford Health
• Treatments: Hydroxychloroquine; Vitamin D

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