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

NCT04435808 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: 20-206
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 Infection

  Number of health care workers who become infected with SARS-CoV-2 as detected by PCR

  3 months

Study Arms (2)

Hydroxychloroquine Arm

EXPERIMENTAL

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).

Drug: Hydroxychloroquine

No Intervention Arm

NO INTERVENTION

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

Interventions

Hydroxychloroquine 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

Hydroxychloroquine Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Walter Dehority
• Organization: The University of New Mexico School of Medicine

wdehority@salud.unm.edu

5052725535

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor: Pediatrics Infectious Disease

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 17, 2020
• Study Start: April 14, 2020
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: February 14, 2022
• Results First Posted: November 16, 2020

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)