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

Phase 2

Completed

• Conditions: SARS-CoV-2; SARS (Severe Acute Respiratory Syndrome); COVID-19; Corona Virus Infection
• Interventions: Drug: Ascorbic Acid; Drug: Hydroxychloroquine Sulfate

• Registration Number: NCT04328961
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-29
• Study Start: 2020-03-31
• Study First Posted: 2020-04-01
• Primary Completion: 2020-09-24
• Study Completion: 2020-10-08
• Results First Submitted: 2021-10-08
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-14
• Last Update Submitted: 2021-12-14
• Results First Posted: 2021-12-16
• Last Update Posted: 2021-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 943

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ascorbic Acid	Ascorbic Acid	Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days
Hydroxychloroquine	Hydroxychloroquine Sulfate	Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days

Primary Outcome Measures

Name	Time	Method
The Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection	Day 28 after enrolment	Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected at study exit
Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection	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

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Had COVID-19 Disease	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.
Rate of Participant-reported Adverse Events	28 days from start of Hydroxychloroquine therapy	Safety and tolerability of Hydroxychloroquine as SARS-CoV-2 PEP in adults

Trial Locations

Locations (8)

University of Washington, Coordinating Center; 🇺🇸 Seattle, Washington, United States

Tulane; 🇺🇸 New Orleans, Louisiana, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

Boston University; 🇺🇸 Boston, Massachusetts, United States

SUNY Upstate Medical University; 🇺🇸 Syracuse, New York, United States

NYU Langone Health; 🇺🇸 New York, New York, United States

UW Virology Research Clinic; 🇺🇸 Seattle, Washington, United States

University of Maryland, Baltimore; 🇺🇸 Baltimore, Maryland, United States