Hydroxychloroquine as Post-Exposure Prophylaxis Against COVID-19 Infection

Randomized, Double-Blind, Controlled Trial of Hydroxychloroquine vs Placebo as Post-Exposure Prophylaxis Against COVID-19 Infection

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.

Study Overview

• Status: Terminated
• Conditions: COVID-19; SARS-CoV 2
• Intervention / Treatment: Drug: Hydroxychloroquine; Dietary supplement: Vitamin D

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort A: Percentage of COVID-19 Exposed Healthcare Workers Treated With Hydroxychloroquine With a Positive COVID-19 Test.	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.	At enrollment completion outcome 1 will be analyzed.
Cohort B: Percentage of COVID-19 Exposed High-risk Individuals Treated With Hydroxychloroquine With a Positive COVID-19 Test.	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.	At enrollment completion outcome 2 will be analyzed.

Collaborators and Investigators

• Sponsor: Sanford Health
• Investigators: Study Chair: Susan Hoover, MD, Sanford Health

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2020
• Primary Completion (Actual): June 4, 2021
• Study Completion (Actual): June 4, 2021

Study Registration Dates

• First Submitted: April 25, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (Actual): May 1, 2020

Study Record Updates

• Last Update Posted (Actual): December 10, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Micronutrients; Vitamins; Bone Density Conservation Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Vitamin D; Hydroxychloroquine
• Other Study ID Numbers: PEPCOH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No