Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers
NCT ID: NCT04371523
Last Updated: 2021-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2020-05-01
2020-08-30
Brief Summary
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1. Determine if prophylactic once weekly hydroxychloroquine reduces the incidence of conversion from SARS-2-CoVnasopharyngeal swab negative to positive
2. To determine if weekly prophylactic hydroxychloroquine reduced the severity of COVID-19 symptoms
3. To determine the safety of taking weekly prophylactic hydroxychloroquine
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Intervention - Hydroxychloroquine
Apo-Hydroxychloroquine
Hydroxychloroquine sulfate 400mg PO BID on day one, then 400mg PO weekly, to be taken with meals for two months total.
Control
Matched Placebo
Matching Placebo
Interventions
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Apo-Hydroxychloroquine
Hydroxychloroquine sulfate 400mg PO BID on day one, then 400mg PO weekly, to be taken with meals for two months total.
Matched Placebo
Matching Placebo
Eligibility Criteria
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Inclusion Criteria
* Healthcare workers with primary practice in intensive care unit, general internal medicine,
* COVID-19 testing centres, emergency rooms, and nursing homes.
* COVID\_19 symptom free at the time of randomization and have a negative diagnostic swab.
Exclusion Criteria
* Suspected COVID-19 positivity defined as possessing symptoms consistent with COVID-19 infections such as: headache, fever, nausea, vomiting, diarrhea, dyspnea, dry cough
* Healthcare workers with pre-existing retinopathy or serious visual problems
* Healthcare workers with known malignancies receiving active chemotherapy or immune modifying medications
* Healthcare workers with known autoimmune disorders
* Healthcare workers with known QT prolongation
* History of ventricular arrhythmias
* Participants at risk of malignant arrythmias ○ At risk defined as: A sudden loss of consciousness with injury; anyone in their immediate family, under the age of 45year, with sudden cardiac death; anyone family history of long QT syndrome
* Known sensitivity/allergy to hydroxychloroquine
* Healthcare workers that are currently pregnant
* Healthcare workers that are already taking chloroquine or hydroxychloroquine
* Healthcare workers on colchicine or any other anti-viral medication
* Healthcare workers taking a medication that may interact with hydroxychloroquine (see table below
* Inability to take oral medications
* Inability to provide written consent
* Known G6PD deficiency
18 Years
ALL
Yes
Sponsors
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St. Joseph's Healthcare Hamilton
OTHER
Responsible Party
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Waleed Al-Hazzani
Intensivist
Locations
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St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Countries
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Other Identifiers
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3190
Identifier Type: -
Identifier Source: org_study_id
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