Status:
TERMINATED
Hydroxychloroquine as Post-Exposure Prophylaxis Against COVID-19 Infection
Lead Sponsor:
Sanford Health
Conditions:
COVID-19
SARS-CoV 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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
- 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
Exclusion
Key Trial Info
Start Date :
May 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04372017
Start Date
May 14 2020
End Date
June 4 2021
Last Update
December 10 2021
Active Locations (1)
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1
Sanford Health
Sioux Falls, South Dakota, United States, 57104