Status:
TERMINATED
Efficacy of Hydroxychloroquine Prophylaxis for Health Care Workers at High Risk for COVID-19
Lead Sponsor:
University of New Mexico
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The HCW Prophylaxis (HCWP) Study, single, open and off label intervention study. Up to 350 participants will be assigned to group that takes HCQ or group that opts to not take study medication. Partic...
Detailed Description
This is an open and off label use, interventional, single site study. The HCWP Study eligibility are HCWs at high risk for SARS-CoV-2 exposure (eg MD/DO, NP, RN, and respiratory therapists in ED, Pedi...
Eligibility Criteria
Inclusion
- Men or women ≥18 years of age who are UNM HEALTH SYSTEM health care workers and are asymptomatic for known presenting symptoms of SARS-CoV-2:
- UNMHS HCWs include: MD/DO, NP, RN, and respiratory therapists working in ED, Pediatric ED, Urgent Care, Pediatric Urgent Care or on Covid-19 units. Study PI's will consider study enrollment of HCWs from other settings, for example certain outpatient clinics or inpatient units.
- Are not positive for SARS-CoV-2 testing
- Willing and able to comply with survey completion, scheduled visits, treatment plan, and other study procedures
- Willing and able to provide informed consent
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, for example anti-arrhythmic agents, digoxin, cyclosporin, cimetidine, or tamoxifen.
- 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 (\<100K)
- 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. There may be some exceptions to requiring a 30-day washout that will be evaluated by the Co-Investigators on a case by case basis.
Key Trial Info
Start Date :
April 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2020
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04435808
Start Date
April 14 2020
End Date
July 15 2020
Last Update
February 14 2022
Active Locations (1)
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1
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87131