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

COVID-19 Clinical Trial

Official title:

Off Label Study to Evaluate the Efficacy of Hydroxychloroquine as Prophylaxis to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection Among Health Care Workers at High Risk of Occupational Exposure to SARS-CoV-2

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04435808
• Other study ID #: 20-206
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: April 14, 2020
• Est. completion date: July 15, 2020

Study information

• Verified date: February 2022
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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, 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: July 15, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
United States	University of New Mexico Health Sciences Center	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS-CoV-2 Infection	Number of health care workers who become infected with SARS-CoV-2 as detected by PCR	3 months