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

STATUS

Recruiting
End date

Apr 14, 2025
participants needed

350
sponsor

University of New Mexico

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Updated on 19 February 2024

See if I qualify

covid-19

SARS

hydroxychloroquine

occupational exposure

pediatric

acute respiratory syndrome (sars)

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) Group B: up to 75 (HCW who choose not to be provided HCQ)

Details

Condition	Covid 19
Age	18-100 years
Treatment	Hydroxychloroquine
Clinical Study Identifier	NCT04435808
Sponsor	University of New Mexico
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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 Criteria
	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

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