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

Primary Purpose

COVID-19

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Hydroxychloroquine

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of New Mexico Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hydroxychloroquine Arm

No Intervention Arm

Arm Description

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

Outcomes

Primary Outcome Measures

SARS-CoV-2 Infection

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04435808

First Posted

June 4, 2020

Last Updated

February 10, 2022

Sponsor

University of New Mexico

1. Study Identification

Unique Protocol Identification Number

NCT04435808

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Terminated

Why Stopped

Stopped for futility by DSMB

Study Start Date

April 14, 2020 (Actual)

Primary Completion Date

July 15, 2020 (Actual)

Study Completion Date

July 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of New Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hydroxychloroquine Arm

Arm Type

Experimental

Arm Description

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).

Arm Title

No Intervention Arm

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Hydroxychloroquine

Intervention Description

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

Primary Outcome Measure Information:

Title

SARS-CoV-2 Infection

Description

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

University of New Mexico Health Sciences Center

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87131

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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