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

• Sponsor: University of New Mexico (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04435808
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Hydroxychloroquine	Phase 1/Phase 2

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)

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Apr 14, 2020
• Actual Primary Completion Date: Jul 15, 2020
• Actual Study Completion Date: Jul 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	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
No Intervention: No Intervention Arm Group B: Up to 75 health care workers who choose not to take hydroxychloroquine.

Outcome Measures

Primary Outcome Measures

1. SARS-CoV-2 Infection [3 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of New Mexico Health Sciences Center	Albuquerque	New Mexico	United States	87131

Sponsors and Collaborators

• University of New Mexico

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 19, 2020
• Informed Consent Form - May 14, 2020

More Information

Publications

None provided.

• Responsible Party: Walter Dehority, Associate Professor: Pediatrics Infectious Disease, University of New Mexico
• ClinicalTrials.gov Identifier: NCT04435808
• Other Study ID Numbers: 20-206
• First Posted: Jun 17, 2020
• Last Update Posted: Feb 14, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: COVID-19; Hydroxychloroquine

Study Results

Participant Flow

Arm/Group Title	Hydroxychloroquine Arm	No Intervention Arm
Arm/Group Description	Group A: 0 health care workers who chose to take hydroxychloroquine Hydroxychloroquine: Hydroxychloroquine- oral administration: Duration: up to 90 days or until meeting study termination criteria. Loading dose: 600 mg once for the first day Maintenance dose: 200 mg, daily	Group B: 1 health care worker who chose not to take hydroxychloroquine
Period Title: Overall Study
STARTED	0	1
COMPLETED	0	0
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Hydroxychloroquine Arm	No Intervention Arm	Total
Arm/Group Description	Group A: 0 health care workers who choose to take hydroxychloroquine Hydroxychloroquine: Hydroxychloroquine- oral administration: Duration: up to 90 days or until meeting study termination criteria. Loading dose: 600 mg once for the first day Maintenance dose: 200 mg, daily	Group B: 1 health care workers who chose not to take hydroxychloroquine	Total of all reporting groups
Overall Participants	0	1	1
Age (Count of Participants)
<=18 years	0 NaN	0 0%	0 0%
Between 18 and 65 years	0 NaN	1 100%	1 100%
>=65 years	0 NaN	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	0 NaN	0 0%	0 0%
Male	0 NaN	1 100%	1 100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 NaN
Region of Enrollment (participants) [Number]
United States	1 Infinity	1 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

DSMB stopped trial early prior to any data collection.

Arm/Group Title	Hydroxychloroquine Arm	No Intervention Arm
Arm/Group Description	Group A: 0 health care workers who chose to take hydroxychloroquine Hydroxychloroquine: Hydroxychloroquine- oral administration: Duration: up to 90 days or until meeting study termination criteria. Loading dose: 600 mg once for the first day Maintenance dose: 200 mg, daily	Group B: 1 health care worker who chose not to take hydroxychloroquine
Measure Participants	0	0

Adverse Events

Time Frame	Not collected
Adverse Event Reporting Description	Not collected
Arm/Group Title	Hydroxychloroquine Arm		No Intervention Arm
Arm/Group Description	Group A: 0 health care workers who chose to take hydroxychloroquine Hydroxychloroquine: Hydroxychloroquine- oral administration: Duration: up to 90 days or until meeting study termination criteria. Loading dose: 600 mg once for the first day Maintenance dose: 200 mg, daily		Group B: 0 health care worker who chose not to take hydroxychloroquine
All Cause Mortality
	Hydroxychloroquine Arm		No Intervention Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Hydroxychloroquine Arm		No Intervention Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Hydroxychloroquine Arm		No Intervention Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.