Clinical trial NCT04372017: Hydroxychloroquine as Post-Exposure Prophylaxis Against COVID-19 Infection
Official title: Randomized, Double-Blind, Controlled Trial of Hydroxychloroquine vs Placebo as Post-Exposure Prophylaxis Against COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: COVID-19
SARS-CoV 2
Lead sponsor: Sanford Health
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Cohort A: Percentage of COVID-19 Exposed Healthcare Workers Treated With Hydroxychloroquine With a Positive COVID-19 Test.
timeFrame: At enrollment completion outcome 1 will be analyzed.
measure: Cohort B: Percentage of COVID-19 Exposed High-risk Individuals Treated With Hydroxychloroquine With a Positive COVID-19 Test.
timeFrame: At enrollment completion outcome 2 will be analyzed.
Secondary outcomes:
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Sanford Health
state: South Dakota
Study officials:
affiliation: Sanford Health
name: Susan Hoover, MD
role: STUDY_CHAIR
References: