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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04328961
Recruitment Status : Completed
First Posted : April 1, 2020
Results First Posted : December 16, 2021
Last Update Posted : December 16, 2021
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Ruanne Barnabas, University of Washington

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
COVID-19 Corona Virus Infection SARS (Severe Acute Respiratory Syndrome) SARS-CoV-2 Drug: Hydroxychloroquine Sulfate Drug: Ascorbic Acid Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 943 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : March 31, 2020
Actual Primary Completion Date : September 24, 2020
Actual Study Completion Date : October 8, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: HCQ arm


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT04328961


Locations
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United States, California
University of California Los Angeles
Los Angeles, California, United States, 90095
United States, Louisiana
Tulane
New Orleans, Louisiana, United States, 70118
United States, Maryland
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02215
United States, New York
NYU Langone Health
New York, New York, United States, 10016
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, Washington
University of Washington, Coordinating Center
Seattle, Washington, United States, 98104
UW Virology Research Clinic
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Bill and Melinda Gates Foundation
Investigators
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Principal Investigator: Ruanne V. Barnabas, MBChB, DPhil University of Washington
  Study Documents (Full-Text)

Documents provided by Ruanne Barnabas, University of Washington:
Study Protocol  [PDF] April 9, 2020
Statistical Analysis Plan  [PDF] August 22, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ruanne Barnabas, Associate Professor, School of Medicine: Global Health, University of Washington
ClinicalTrials.gov Identifier: NCT04328961    
Other Study ID Numbers: STUDY00009750
INV-016204 ( Other Grant/Funding Number: Bill and Melinda Gates Foundation )
First Posted: April 1, 2020    Key Record Dates
Results First Posted: December 16, 2021
Last Update Posted: December 16, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data from the study will be made available in accordance with the funder's open access policy.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Analytic Code
Time Frame: Within 3 months of publication of primary results.
Access Criteria: De-identified data from the study will be made available in accordance with the funder's open access policy.
URL: https://www.gatesfoundation.org/how-we-work/general-information/open-access-policy

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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
Keywords provided by Ruanne Barnabas, University of Washington:
novel coronavirus
post-exposure prophylaxis
Additional relevant MeSH terms:
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Infections
COVID-19
Severe Acute Respiratory Syndrome
Coronavirus Infections
Syndrome
Disease
Pathologic Processes
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
 Respiratory Tract Diseases
Ascorbic Acid
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Antioxidants
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients