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Hydroxychloroquine as Post-Exposure Prophylaxis Against COVID-19 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04372017
Recruitment Status : Recruiting
First Posted : May 1, 2020
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Sanford Health

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.

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV 2 Drug: Hydroxychloroquine Dietary Supplement: Vitamin D Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1739 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomized, Double-Blind, Controlled Trial of Hydroxychloroquine vs Placebo as Post-Exposure Prophylaxis Against COVID-19 Infection
Estimated Study Start Date : May 14, 2020
Estimated Primary Completion Date : April 20, 2022
Estimated Study Completion Date : April 20, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort A: Healthcare worker (hydroxychloroquine) Drug: Hydroxychloroquine
Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.

Placebo Comparator: Cohort A: Healthcare worker (placebo) Dietary Supplement: Vitamin D
Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.

Experimental: Cohort B: High-Risk participant (hydroxychloroqine) Drug: Hydroxychloroquine
Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.

Placebo Comparator: Cohort B: High-Risk participant (placebo) Dietary Supplement: Vitamin D
Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.




Primary Outcome Measures :
  1. Cohort A: Percentage of COVID-19 exposed healthcare workers treated with hydroxychloroquine with a positive COVID-19 test. [ Time Frame: At enrollment completion outcome 1 will be analyzed. ]
    Determine whether post-exposure prophylaxis with hydroxychloroquine can prevent COVID-19 in healthcare workers who have been exposed to a known case of COVID-19.

  2. Cohort B: Percentage of COVID-19 exposed high-risk individuals treated with hydroxychloroquine with a positive COVID-19 test. [ Time Frame: At enrollment completion outcome 2 will be analyzed. ]
    Determine whether post-exposure prophylaxis with hydroxychloroquine can prevent COVID-19 in high-risk individuals who have been exposed to a known case of COVID-19.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04372017


Contacts
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Contact: Christie Ellison, BSN 605-312-6030 christie.ellison@sanfordhealth.org

Locations
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United States, South Dakota
Sanford Health Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Clinical Trials Office    605-312-6023      
Principal Investigator: Susan Hoover, MD         
Sponsors and Collaborators
Sanford Health
Investigators
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Study Chair: Susan Hoover, MD Sanford Health
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Responsible Party: Sanford Health
ClinicalTrials.gov Identifier: NCT04372017    
Other Study ID Numbers: PEPCOH
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Infection
Vitamin D
Hydroxychloroquine
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents