Preventing COVID-19 in Healthcare Workers With HCQ: A RCT

Study Overview
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Brief Summary
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Healthcare workers (HCW) at risk of Covid-19 will have baseline serology for SARS-CoV-2 to see if they are already immune to Covid-19. HCW will get baseline assessment and if meeting inclusion criteria and no exclusion criteria they will be randomized in a 2:1 ratio to hydroxychloroquine or Vitamin C on a weekly basis for three months. Subjects will complete daily diary of symptoms and temperature, and will have repeat SARS-CoV-2 serology at 6 weeks and 3 months to determine seroconversion.

Detailed Description
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Healthcare workers (HCW) at risk of Covid-19 will have baseline serology for SARS-CoV-2 to see if they are already immune to Covid-19. HCW will get baseline assessment and if meeting inclusion criteria and no exclusion criteria they will be randomized in a 2:1 ratio to hydroxychloroquine or Vitamin C on a weekly basis for three months. Subjects will complete daily diary of symptoms and temperature, and will have repeat SARS-CoV-2 serology at 6 weeks and 3 months to determine seroconversion.

Official Title
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Prophylactic Hydroxychloroquine vs Vitamin C in Healthcare Workers at Risk of COVID-19: A RCT

Conditions
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Covid-19

Intervention / Treatment
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* Drug: Hydroxychloroquine
* Other: Vitamin C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthcare worker at risk of Covid-19 Exclusion Criteria: Known hypersensitivity or allergic reactions to 4-aminoquinoline compounds or its ingredients. Current, or history of, ocular macular disease or retinal damage. Current, or history of, subnormal glomerular filtration. Current use of tamoxifen citrate. Current, or history of, cardiomyopathy, atrial, nodal, or ventricular arrhythmias, torsades de pointes, conduction disorders (bundle branch block/atrio-ventricular heart block) or biventricular hypertrophy. Subjects taking other drugs that have the potential to prolong QT interval if taken with HCQ.

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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No

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
Interventional Model Description: Open label, controlled, RCT
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydroxychloroquine<br>Oral loading dose of 800 mg followed by once weekly oral hydroxychloroquine 400 mg for 3 months | Drug: Hydroxychloroquine<br>* Oral loading dose followed by once weekly dosing<br>|
| Active Comparator: Vitamin C<br>Oral Vitamin C 1,000 mg daily for three months | Other: Vitamin C<br>* Once daily vitamin C 1 gm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 Seroconversion rate | Percentage of healthcare worker who develop antibodies to SARS-CoV-2 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Admission for Covid-19 | Percentage of study subjects who require admission to a hospital for Covid-19 | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covid-19, healthcare workers, prophylaxis, hydroxychloroquine