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.
Drug: Hydroxychloroquine Sulfate
Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy
Other Name: HCQ arm
Drug: Ascorbic Acid
Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.
Other Name: Placebo arm
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
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
Ruanne V. Barnabas, MBChB, DPhil, Principal Investigator
University of Washington