Status:
COMPLETED
Hydroxychloroquine for COVID-19 Post-exposure Prophylaxis (PEP)
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Conditions:
COVID-19
Corona Virus Infection
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
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 a...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2020
Estimated Enrollment :
943 Patients enrolled
Trial Details
Trial ID
NCT04328961
Start Date
March 31 2020
End Date
October 8 2020
Last Update
December 16 2021
Active Locations (8)
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1
University of California Los Angeles
Los Angeles, California, United States, 90095
2
Tulane
New Orleans, Louisiana, United States, 70118
3
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
4
Boston University
Boston, Massachusetts, United States, 02215