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

NCT ID: NCT04328961

Last Updated: 2021-12-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

943 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-31

Study Completion Date

2020-10-08

Brief Summary

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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

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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.

Conditions

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COVID-19 Corona Virus Infection SARS (Severe Acute Respiratory Syndrome) SARS-CoV-2

Keywords

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novel coronavirus post-exposure prophylaxis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ascorbic Acid

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

Group Type PLACEBO_COMPARATOR

Ascorbic Acid

Intervention Type DRUG

Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.

Hydroxychloroquine

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

Group Type EXPERIMENTAL

Hydroxychloroquine Sulfate

Intervention Type DRUG

Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy

Interventions

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Hydroxychloroquine Sulfate

Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy

Intervention Type DRUG

Ascorbic Acid

Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.

Intervention Type DRUG

Other Intervention Names

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HCQ arm Placebo arm

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Ruanne Barnabas

Associate Professor, School of Medicine: Global Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ruanne V. Barnabas, MBChB, DPhil

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of California Los Angeles

Los Angeles, California, United States

Site Status

Tulane

New Orleans, Louisiana, United States

Site Status

University of Maryland, Baltimore

Baltimore, Maryland, United States

Site Status

Boston University

Boston, Massachusetts, United States

Site Status

NYU Langone Health

New York, New York, United States

Site Status

SUNY Upstate Medical University

Syracuse, New York, United States

Site Status

University of Washington, Coordinating Center

Seattle, Washington, United States

Site Status

UW Virology Research Clinic

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33284679 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32493478 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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INV-016204

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00009750

Identifier Type: -

Identifier Source: org_study_id