Hydroxychloroquine as Post-Exposure Prophylaxis Against COVID-19 Infection

NCT04372017 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: PEPCOH
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (4)

Cohort A: Healthcare worker (hydroxychloroquine)

EXPERIMENTAL

Drug: Hydroxychloroquine

Cohort A: Healthcare worker (placebo)

PLACEBO COMPARATOR

Dietary Supplement: Vitamin D

Cohort B: High-Risk participant (hydroxychloroqine)

EXPERIMENTAL

Drug: Hydroxychloroquine

Cohort B: High-Risk participant (placebo)

PLACEBO COMPARATOR

Dietary Supplement: Vitamin D

Interventions

Hydroxychloroquine DRUG

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

Cohort A: Healthcare worker (hydroxychloroquine); Cohort B: High-Risk participant (hydroxychloroqine)

Vitamin D DIETARY_SUPPLEMENT

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

Cohort A: Healthcare worker (placebo); Cohort B: High-Risk participant (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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)
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sanford Health: lead

Study Sites (1)

Sanford Health

Sioux Falls, South Dakota, 57104, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine; Vitamin D

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Susan Hoover
• Organization: Sanford Health

Susan.Hoover@sanfordhealth.org

605-328-8120

Study Officials

• Susan Hoover, MD

  Sanford Health

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2020
• First Posted: May 1, 2020
• Study Start: May 14, 2020
• Primary Completion: June 4, 2021
• Study Completion: June 4, 2021
• Last Updated: December 10, 2021
• Results First Posted: December 10, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)