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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04435808
Recruitment Status : Recruiting
First Posted : June 17, 2020
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Walter Dehority, University of New Mexico

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 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 : April 14, 2020
Estimated Primary Completion Date : April 14, 2021
Estimated Study Completion Date : April 14, 2025


Arm Intervention/treatment
Experimental: Hydroxychloroquine Arm
Group A: up to 275 health care workers who choose to take hydroxychloroquine
Drug: 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


No Intervention: No Intervention Arm
Group B: Up to 75 health care workers who choose not to take hydroxychloroquine



Primary Outcome Measures :
  1. SARS-CoV-2 Infection [ Time Frame: 3 months ]
    Number of health care workers who become infected with SARS-CoV-2 as detected by PCR


Secondary Outcome Measures :
  1. Symptomatic vs. Asymptomatic Infection with SARS-CoV-2 [ Time Frame: 3 months ]
    Determine the frequency of symptomatic vs. asymptomatic SARS-CoV-2 infections in health care workers during the study via serial PCR testing and symptom surveys

  2. Occupational Health Exposure [ Time Frame: 3 months ]
    Assess the role of exposure levels to Covid-19 patients amongst health care workers and its impact of infection rates

  3. Impact of Hydroxychloroquine use on Need for Hospitalization with SARS-CoV-2 Infection [ Time Frame: 3 months ]
    Will assess the severity of any SARS-CoV-2 infections amongst health care workers taking and not taking hydroxychloroquine. This will include assessments of hospital admissions.

  4. Impact of Hydroxychloroquine use on Need for ICU Care with SARS-CoV-2 Infection [ Time Frame: 3 months ]
    Will assess the severity of any SARS-CoV-2 infections amongst health care workers taking and not taking hydroxychloroquine. This will include determination of the need for ICU care.

  5. Adverse Effect Profile of Hydroxychloroquine [ Time Frame: 3 months ]
    Will assess the adverse effect profile of the study drug via serial surveys

  6. Seroconversion Following SARS-CoV-2 Infection [ Time Frame: 3 months ]
    Will collect monthly blood samples for serological analysis

  7. Metagenomic Next Generation Sequencing of SARS-CoV-2 Isolates [ Time Frame: 3 months ]
    Will perform mNGS on any recovered SARS-CoV-2 isolates from subjects to identify the genomic lineage of the virus and to compare this with SARS-CoV-2 genomes circulating in the hospital system, the community and nationally. This may provide evidence as to the source of the infection (e.g. a hospital-based infection vs. a community infection vs. a travel-associated infection out of state).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04435808


Contacts
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Contact: Walter Dehority, MD 505-272-5551 WDehority@salud.unm.edu
Contact: Hadya Khawaja, MS 505-272-9145 hkhawaja@salud.unm.edu

Locations
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United States, New Mexico
University of New Mexico Health Sciences Center Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Walter Dehority, MD    505-272-5535    WDehority@salud.unm.edu   
Contact: Hadya Khawaja, MS    505-272-9145    hkhawaja@salud.unm.edu   
Sponsors and Collaborators
University of New Mexico
  Study Documents (Full-Text)

Documents provided by Walter Dehority, University of New Mexico:
Informed Consent Form  [PDF] May 14, 2020

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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: June 17, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents