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

Primary Purpose

COVID-19, Corona Virus Infection, SARS (Severe Acute Respiratory Syndrome)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine Sulfate
Ascorbic Acid
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring novel coronavirus, post-exposure prophylaxis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California Los Angeles
  • Tulane
  • University of Maryland, Baltimore
  • Boston University
  • NYU Langone Health
  • SUNY Upstate Medical University
  • University of Washington, Coordinating Center
  • UW Virology Research Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Ascorbic Acid

Hydroxychloroquine

Arm Description

Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days

Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days

Outcomes

Primary Outcome Measures

Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection
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
The Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection
Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected at study exit

Secondary Outcome Measures

Rate of Participant-reported Adverse Events
Safety and tolerability of Hydroxychloroquine as SARS-CoV-2 PEP in adults
Number of Participants Who Had COVID-19 Disease
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.

Full Information

First Posted
March 23, 2020
Last Updated
December 14, 2021
Sponsor
University of Washington
Collaborators
Bill and Melinda Gates Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04328961
Brief Title
Hydroxychloroquine for COVID-19 Post-exposure Prophylaxis (PEP)
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 31, 2020 (Actual)
Primary Completion Date
September 24, 2020 (Actual)
Study Completion Date
October 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Bill and Melinda Gates Foundation

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Corona Virus Infection, SARS (Severe Acute Respiratory Syndrome), SARS-CoV-2
Keywords
novel coronavirus, post-exposure prophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
943 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ascorbic Acid
Arm Type
Placebo Comparator
Arm Description
Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days
Arm Title
Hydroxychloroquine
Arm Type
Experimental
Arm Description
Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine Sulfate
Other Intervention Name(s)
HCQ arm
Intervention Description
Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy
Intervention Type
Drug
Intervention Name(s)
Ascorbic Acid
Other Intervention Name(s)
Placebo arm
Intervention Description
Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.
Primary Outcome Measure Information:
Title
Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection
Description
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
Time Frame
Day 1 through Day 14 after enrolment
Title
The Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection
Description
Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected at study exit
Time Frame
Day 28 after enrolment
Secondary Outcome Measure Information:
Title
Rate of Participant-reported Adverse Events
Description
Safety and tolerability of Hydroxychloroquine as SARS-CoV-2 PEP in adults
Time Frame
28 days from start of Hydroxychloroquine therapy
Title
Number of Participants Who Had COVID-19 Disease
Description
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.
Time Frame
28 days from enrolment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: Household contact (i.e., residing with the index case in the 14 days prior to index diagnosis) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruanne V. Barnabas, MBChB, DPhil
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Tulane
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Facility Name
University of Maryland, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
University of Washington, Coordinating Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
UW Virology Research Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.gatesfoundation.org/how-we-work/general-information/open-access-policy
Citations:
PubMed Identifier
33284679
Citation
Barnabas RV, Brown ER, Bershteyn A, Stankiewicz Karita HC, Johnston C, Thorpe LE, Kottkamp A, Neuzil KM, Laufer MK, Deming M, Paasche-Orlow MK, Kissinger PJ, Luk A, Paolino K, Landovitz RJ, Hoffman R, Schaafsma TT, Krows ML, Thomas KK, Morrison S, Haugen HS, Kidoguchi L, Wener M, Greninger AL, Huang ML, Jerome KR, Wald A, Celum C, Chu HY, Baeten JM; Hydroxychloroquine COVID-19 PEP Study Team. Hydroxychloroquine as Postexposure Prophylaxis to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 Infection : A Randomized Trial. Ann Intern Med. 2021 Mar;174(3):344-352. doi: 10.7326/M20-6519. Epub 2020 Dec 8. Erratum In: Ann Intern Med. 2021 Mar;174(3):435.
Results Reference
derived
PubMed Identifier
32493478
Citation
Barnabas RV, Brown E, Bershteyn A, Miller RS, Wener M, Celum C, Wald A, Chu H, Wesche D, Baeten JM; Hydroxychloroquine COVID-19 PEP Study Team. Efficacy of hydroxychloroquine for post-exposure prophylaxis to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among adults exposed to coronavirus disease (COVID-19): a structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jun 3;21(1):475. doi: 10.1186/s13063-020-04446-4.
Results Reference
derived

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

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