Efficacy of Hydroxychloroquine Prophylaxis for Health Care Workers at High Risk for COVID-19

• Status: Terminated
• Trial end date: 2020-07-15
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of New Mexico
• Treatments: Hydroxychloroquine

Criteria

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.