Efficacy of Hydroxychloroquine Prophylaxis for Health Care Workers at High Risk for COVID-19
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|ClinicalTrials.gov Identifier: NCT04435808|
Recruitment Status : Terminated (Stopped for futility by DSMB)
First Posted : June 17, 2020
Results First Posted : November 16, 2020
Last Update Posted : November 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Hydroxychloroquine||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||July 15, 2020|
|Actual Study Completion Date :||July 15, 2020|
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).
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.
- SARS-CoV-2 Infection [ Time Frame: 3 months ]Number of health care workers who become infected with SARS-CoV-2 as detected by PCR
- 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
- 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
- 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.
- 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.
- Adverse Effect Profile of Hydroxychloroquine [ Time Frame: 3 months ]Will assess the adverse effect profile of the study drug via serial surveys
- Seroconversion Following SARS-CoV-2 Infection [ Time Frame: 3 months ]Will collect monthly blood samples for serological analysis
- 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).
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
|United States, New Mexico|
|University of New Mexico Health Sciences Center|
|Albuquerque, New Mexico, United States, 87131|