Hydroxychloroquine in the Prevention of COVID-19 Infection in Healthcare Workers

Study Overview
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Brief Summary
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In order to assess the efficacy of hydroxychloroquine treatment weekly for a total of 7 weeks in the prevention of COVID-19 infection, three hundred sixty (360) Healthcare workers with high risk exposure to patients infected with COVID-19 will be tested for COVID-19 infection via nasopharyngeal (NP) swab once weekly for 7 weeks. Of those, one hundred eighty (180) will receive weekly doses of hydroxychloroquine for the duration of the study. Subjects who opt not to receive the study drug will form the control group.

Official Title
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A Prospective Clinical Study of Hydroxychloroquine in the Prevention of SARS- CoV-2 (COVID-19) Infection in Healthcare Workers After High-risk Exposures

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Hydroxychloroquine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male and female healthcare workers ≥ 18 to ≤ 75 years of age upon study consent Healthcare workers with • One day or more of exposure to suspect and/or positive COVID-19 patients, including but not limited to those working in the Emergency Department or Intensive Care Unit. OR • Unprotected exposure to a known positive COVID-19 patient within 72 hours of screening. Afebrile with no constitutional symptoms Willing and able to comply with scheduled visits, treatment plan, and other study procedures Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures Exclusion Criteria: Participation in other investigational clinical trials for the treatment or prevention of SARS-COV-2 infection within 30days Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) during Screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested Note: the following criteria follow standard clinical practice for FDA approved indications of this medication Having a prior history of blood disorders such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia Having a prior history of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency Having dermatitis, psoriasis or porphyria Taking Digoxin, Mefloquine, methotrexate, cyclosporine, praziquantel, antacids and kaolin, cimetidine, ampicillin, Insulin or antidiabetic drugs, arrhythmogenic drugs, antiepileptic drugs, loop, thiazide, and related diuretics, laxatives and enemas, amphotericin B, high dose corticosteroids, and proton pump inhibitors, neostigmine, praziquantel, Pyridostigmine, tamoxifen citrate Allergies: 4-Aminoquinolines Pre-existing retinopathy of the eye Has a chronic liver disease or cirrhosis, including hepatitis B and/or untreated hepatitis Untreated or uncontrolled active bacterial, fungal infection Known or suspected active drug or alcohol abuse, per investigator judgment Women who are pregnant or breastfeeding Known hypersensitivity to any component of the study drug A known history of prolonged QT syndrome or history of additional risk factors for torsades de pointe (e.g., heart failure, requires a lab test , family history of Long QT Syndrome), or the use of concomitant medications that prolong the QT/QTc interval

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydroxychloroquine<br>Subjects who chose to enter the HCQ arm received a loading dose of 800 mg HCQ on day 1 followed by two 200 mg tablets once a week for a total of 7 weeks | Drug: Hydroxychloroquine<br>* Weekly treatment in individuals at high risk<br>* Other names: HCQ;|
| No Intervention: Control<br>Subjects who declined taking HCQ were considered as controls | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Infected With COVID-19 or COVID-19 Like Illness During the Trial | Number of participants infected with COVID-19 or identified as having COVID-19 like illness during the trial | Up to 7 weeks after study initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time From Study Initiation Until the Occurrence of COVID-19 or COVID-19 Like Illness or Being Censored | Time-to-first clinical event consisting of a persistent change for any of the following: diagnosis of COVID-19 clinical characteristics of COVID-19 like illness being censored | Up to 7 weeks after study initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hydroxychloroquine