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

University of Washington943 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

943

Conditions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (8)

University of California Los Angeles

Los Angeles, California, United States

Tulane

New Orleans, Louisiana, United States

University of Maryland, Baltimore

Baltimore, Maryland, United States

Boston University

Boston, Massachusetts, United States

NYU Langone Health

New York, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

University of Washington, Coordinating Center

Seattle, Washington, United States

UW Virology Research Clinic

Seattle, Washington, United States

Outcomes

Primary Outcomes

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

Time frame: Day 1 through Day 14 after enrolment

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

Time frame: Day 28 after enrolment

Secondary Outcomes

Rate of Participant-reported Adverse Events

Safety and tolerability of Hydroxychloroquine as SARS-CoV-2 PEP in adults

Time frame: 28 days from start of Hydroxychloroquine therapy

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.

Time frame: 28 days from enrolment