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. Participants will be UNM HEALTH SYSTEM HCW at high risk for occupational exposure to SARSCoV- 2. Study timepoints will include Day 1 screening/enrollment, 30 day, 60 day, and 90 day assessments. Questionnaires will be collected in all timepoints.
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, Pediatric ED, Urgent Care, Pediatric Urgent Care and on Covid-19 units) at
UNM HEALTH SYSTEM meeting all inclusion criteria. Total number of participants: 350 (Group A
and B) Group A: up to 275 (HCW who choose to be provided HCQ). Will receive a 600 mg loading
dose followed by 200 mg daily (tablets).
Group B: up to 75 (HCW who choose not to be provided HCQ)
Drug: Hydroxychloroquine
Hydroxychloroquine- oral administration: Duration: up to 90 days or until meeting study termination criteria. Subjects will recieve 600 mg loading dose, followed by 200 mg daily (tablets).
Loading dose: 600 mg once for the first day Maintenance dose: 200 mg, daily
Inclusion Criteria:
1. 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:
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.
3. Are not positive for SARS-CoV-2 testing
4. Willing and able to comply with survey completion, scheduled visits, treatment plan,
and other study procedures
5. Willing and able to provide informed consent
Exclusion Criteria:
1. Known hypersensitivity to HCQ or other 4-aminoquinoline compounds
2. Currently hospitalized
3. Symptomatic with subjective fever, cough, or sore throat
4. Current medications exclude concomitant use of HCQ, for example anti-arrhythmic
agents, digoxin, cyclosporin, cimetidine, or tamoxifen.
5. Concomitant use of other anti-malarial treatment or chemoprophylaxis
6. History of retinopathy of any etiology
7. Psoriasis
8. Porphyria
9. Known bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes
<1500) or thrombocytopenia (<100K)
10. Known liver disease
11. Known long QT syndrome
12. 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.
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States