Hydroxychloroquine for COVID-19 Post-exposure Prophylaxis (PEP)

December 14, 2021 updated by: Ruanne Barnabas, University of Washington

Efficacy of Hydroxychloroquine for Post-exposure Prophylaxis (PEP) to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection Among Adults Exposed to Coronavirus Disease (COVID-19): a Blinded, Randomized Study

This is a clinical study for the prevention of SARS-CoV-2 infection in adults exposed to the virus. This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age (inclusive) who are close contacts of persons with laboratory confirmed SARS-CoV-2 or clinically suspected COVID-19. Eligible participants will be enrolled and randomized to receive the intervention or placebo at the level of the household (all eligible participants in one household will receive the same intervention).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, multi-center, placebo-equivalent (ascorbic acid) controlled, blinded study of Hydroxychloroquine (HCQ) post-exposure prophylaxis (PEP) for the prevention of SARS-CoV-2 infection in adults exposed to the virus.The overarching goal of this study is to assess the effectiveness of HCQ PEP on the incidence of SARS-CoV-2 detection by polymerase chain reaction (PCR) to inform public health control strategies.This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age (inclusive) at baseline who are close contacts of persons with PCR-confirmed SARS-CoV-2 or clinically suspected COVID-19 and a pending SARS-CoV-2 PCR test. Eligible participants will be enrolled and randomized 1:1 to HCQ or ascorbic acid at the level of the household (all eligible participants in one household will receive the same intervention). Participants will be counseled about the preliminary in vitro data on HCQ activity against SARS CoV-2 and equipoise regarding efficacy in humans.The duration of study participation will be approximately 28 days.

Study Type

Interventional

Enrollment (Actual)

943

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California Los Angeles
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
        • Tulane
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Baltimore
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Boston University
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • Washington
      • Seattle, Washington, United States, 98104
        • UW Virology Research Clinic
      • Seattle, Washington, United States, 98104
        • University of Washington, Coordinating Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or women 18 to 80 years of age inclusive, at the time of signing the informed consent
  • Willing and able to provide informed consent

  • Had a close contact of a person (index) with known PCR-confirmed SARS-CoV-2 infection or who is currently being assessed for COVID-19. Close contact defined as:

    1. Household contact (i.e., residing with the index case in the 14 days prior to index diagnosis)
    2. Medical staff, first responders, or other care persons who cared for the index case without personal protection (mask and gloves)
  • Less than 4 days since last exposure (close contact with a person with SARS-CoV-2 infection) to the index case
  • Body weight < 100 kg (self-reported)
  • Access to device and internet for Telehealth visits

Exclusion Criteria:

  • Known hypersensitivity to HCQ or other 4-aminoquinoline compounds
  • Currently hospitalized
  • Symptomatic with subjective fever, cough, or sore throat
  • Current medications exclude concomitant use of HCQ
  • Concomitant use of other anti-malarial treatment or chemoprophylaxis
  • History of retinopathy of any etiology
  • Psoriasis
  • Porphyria
  • Known bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes < 1500) or thrombocytopenia (< 100 K)
  • Concomitant use of digoxin, cyclosporin, cimetidine, or tamoxifen
  • Known liver disease
  • Known long QT syndrome
  • Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of the study drugs, or planned use during the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Ascorbic Acid
Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days
Drug: Ascorbic Acid
Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.
Other Names:
  • Placebo arm
EXPERIMENTAL: Hydroxychloroquine
Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days
Drug: Hydroxychloroquine Sulfate
Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy
Other Names:
  • HCQ arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection
Time Frame: Day 1 through Day 14 after enrolment
Polymerase chain reaction (PCR) confirmed severe acute respiratory syndrome coronavirus 2 of the genus Betacoronavirus (SARS-CoV-2) infection from self-collected samples collected daily for 14 days
Day 1 through Day 14 after enrolment
The Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection
Time Frame: Day 28 after enrolment
Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected at study exit
Day 28 after enrolment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Participant-reported Adverse Events
Time Frame: 28 days from start of Hydroxychloroquine therapy
Safety and tolerability of Hydroxychloroquine as SARS-CoV-2 PEP in adults
28 days from start of Hydroxychloroquine therapy
Number of Participants Who Had COVID-19 Disease
Time Frame: 28 days from enrolment
Participants who had a PCR-confirmed SARS-CoV-2 infection and met the Center for Disease Control (CDC) defined criteria for symptomatic COVID-19 disease.
28 days from enrolment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Bill and Melinda Gates Foundation

Investigators

  • Principal Investigator: Ruanne V. Barnabas, MBChB, DPhil, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 31, 2020

Primary Completion (ACTUAL)

September 24, 2020

Study Completion (ACTUAL)

October 8, 2020

Study Registration Dates

First Submitted

March 23, 2020

First Submitted That Met QC Criteria

March 29, 2020

First Posted (ACTUAL)

April 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 16, 2021

Last Update Submitted That Met QC Criteria

December 14, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00009750
  • INV-016204 (OTHER_GRANT: Bill and Melinda Gates Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data from the study will be made available in accordance with the funder's open access policy.

IPD Sharing Time Frame

Within 3 months of publication of primary results.

IPD Sharing Access Criteria

De-identified data from the study will be made available in accordance with the funder's open access policy.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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