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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04328961
Recruitment Status : Recruiting
First Posted : April 1, 2020
Last Update Posted : May 14, 2020
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Ruanne Barnabas, University of Washington

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 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
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 31, 2020


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




Primary Outcome Measures :
  1. Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection [ Time Frame: Day 1 through Day 14 after enrolment ]
    Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected daily for 14 days

  2. 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. Incidence rates of COVID-19 through study completion [ Time Frame: 28 days from enrolment ]
    PCR-confirmed COVID-19 diagnosis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

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


Contacts
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Contact: Meighan Krows 206-520-3833 meigs@uw.edu
Contact: Research Coordinator icrcmta@uw.edu

Locations
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United States, California
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Ryan M Kofron, MS    216-272-3502    RKofron@mednet.ucla.edu   
Principal Investigator: Raphael Landovitz, MD         
United States, Louisiana
Tulane Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Shannon Watson    504-988-8268    swatson7@tulane.edu   
Contact: Norine Schmidt       nschmid1@tulane.edu   
Principal Investigator: Patricia Kissinger, PhD         
Principal Investigator: Alfred Luk, MD         
United States, Maryland
University of Maryland, Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Contact: Colleen Boyce       cboyce@som.umaryland.edu   
Principal Investigator: Kathleen M Neuzil, MD         
United States, Massachusetts
Boston University Recruiting
Boston, Massachusetts, United States, 02215
Contact: Lori Henault       Lori.Henault@bmc.org   
Principal Investigator: Michael Paasche-Orlow, MD         
United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Jane Coates       covidpep@nyulangone.org   
Contact: Stefanie Bendik       covidpep@nyulangone.org   
Principal Investigator: Anna Bershteyn, PhD         
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Michelle Klick    315-464-5729    klickm@upstate.edu   
Principal Investigator: Kristopher Paolino, MD         
United States, Washington
University of Washington, Coordinating Center Active, not recruiting
Seattle, Washington, United States, 98104
UW Virology Research Clinic Recruiting
Seattle, Washington, United States, 98104
Contact: Kirsten Hauge    206-520-4341    kahauge@uw.edu   
Principal Investigator: Helen Stankiewicz Karita, MD         
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
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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
Last Update Posted: May 14, 2020
Last Verified: May 2020
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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Infection
Coronavirus Infections
Severe Acute Respiratory Syndrome
Syndrome
Disease
Pathologic Processes
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
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
Nutrients
Growth Substances