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

NCT ID: NCT04435808

Last Updated: 2022-02-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-14
• Study Completion Date: 2020-07-15

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. 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.

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, 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)

Conditions

COVID-19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Hydroxychloroquine Arm

Group A: up to 275 health care workers who choose to take hydroxychloroquine. Will receive a 600 mg loading dose, followed by 200 mg daily (tablets).

Group Type: EXPERIMENTAL

Hydroxychloroquine

Intervention Type: DRUG

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

No Intervention Arm

Group B: Up to 75 health care workers who choose not to take hydroxychloroquine.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Walter Dehority

Associate Professor: Pediatrics Infectious Disease

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

20-206

Identifier Type: -

Identifier Source: org_study_id