Hydroxychloroquine to Prevent SARS-CoV-2 Infection/COVID-19

Study Overview
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Brief Summary
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The purpose of this study is to determine whether hydroxychloroquine is an effective prophylactic regimen to prevent SARS-CoV-2 infection among healthcare workers. Participants will be randomized into two parallel groups. The first arm will evaluate the use of hydroxychloroquine every-other-day plus standard measures of protection for the prevention of SARS-CoV-2. The second arm will evaluate the use of standard measures of protection for the prevention of SARS-CoV-2. The target enrollment is 320 participants. Each study participant will be monitored for SARS-CoV-2 seroconversion in weekly visits or for the development of COVID-19 symptoms for 8 weeks.

Official Title
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Hydroxychloroquine to Prevent SARS-CoV-2 Infection Among Healthcare Workers: Randomized Controlled, Open-label, Phase 3 Clinical Trial

Conditions
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SARS-CoV-2

Intervention / Treatment
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* Drug: Hydroxychloroquine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthcare workers in service during the COVID-19 outbreak including medical, nurse, technical, and auxiliary staff. Negative rapid serologic and molecular testing for SARS-CoV-2. Written informed consent. Exclusion Criteria: Presents COVID-19 symptoms including cough, fever, myalgias, headaches, loss of smell, and taste. Prior (last 30 days), current or planned use (during study period) of hydroxychloroquine, chloroquine sulfate, or azithromycin. Known cardiac disease or a history of prolonged QT syndrome. Known allergy or intolerance to hydroxychloroquine and/or chloroquine sulfate. Use of concomitant medications that are contraindicated with the use of hydroxychloroquine. Other reported medical conditions, such as glucose-6-phosphate dehydrogenase deficiency, hepatic or renal insufficiency, or visual acuity or field disturbances, that make study participation not in the individual's best interest.

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydroxychloroquine<br>Hydroxychloroquine prophylaxis plus standard measures of personal protection. | Drug: Hydroxychloroquine<br>* A loading dose of 600mg of hydroxychloroquine orally on the first day, followed by 400mg of hydroxychloroquine orally every-other-day and use of standard measures of personal protection provided from the hospital for 8 weeks.<br>|
| No Intervention: Control<br>Standard measures of personal protection. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Proportion of participants with positive molecular or serologic testing for SARS-CoV-2 |  | Eight weeks | 
| Safety: Proportion of participants with grade 3 or more adverse events |  | Eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability: Proportion of participants that discontinue prophylactic treatment due to grade 1 or 2 adverse events |  | Eight weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2 infection, Hydroxychloroquine