Hydroxychloroquine as Post-Exposure Prophylaxis Against COVID-19 Infection

NCT ID: NCT04372017

Last Updated: 2021-12-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-14
• Study Completion Date: 2021-06-04

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.

Conditions

COVID-19; SARS-CoV 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Cohort A: Healthcare worker (hydroxychloroquine)

Group Type: EXPERIMENTAL

Hydroxychloroquine

Intervention Type: DRUG

Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.

Cohort A: Healthcare worker (placebo)

Group Type: PLACEBO_COMPARATOR

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.

Cohort B: High-Risk participant (hydroxychloroqine)

Group Type: EXPERIMENTAL

Hydroxychloroquine

Intervention Type: DRUG

Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.

Cohort B: High-Risk participant (placebo)

Group Type: PLACEBO_COMPARATOR

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.

Interventions

Hydroxychloroquine

Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.

Intervention Type: DRUG

Vitamin D

Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• ≥ 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

• ≥ 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanford Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Hoover, MD

Role: STUDY_CHAIR

Sanford Health

Locations

Sanford Health

Sioux Falls, South Dakota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

PEPCOH

Identifier Type: -

Identifier Source: org_study_id