PROVIDE: Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers
Study Details
Study Description
Brief Summary
The objectives of PROVIDE are to:
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Determine if prophylactic once weekly hydroxychloroquine reduces the incidence of conversion from SARS-2-CoVnasopharyngeal swab negative to positive
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To determine if weekly prophylactic hydroxychloroquine reduced the severity of COVID-19 symptoms
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To determine the safety of taking weekly prophylactic hydroxychloroquine
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Intervention - Hydroxychloroquine
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Drug: Apo-Hydroxychloroquine
Hydroxychloroquine sulfate 400mg PO BID on day one, then 400mg PO weekly, to be taken with meals for two months total.
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Placebo Comparator: Control
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Drug: Matched Placebo
Matching Placebo
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Outcome Measures
Primary Outcome Measures
- Positive for SARS-CoV-2 [8 weeks]
The number of HCW that tested positive for SARS-CoV-2
Secondary Outcome Measures
- Hospital admissions [at any time after first dose to hospital discharge, truncated at 60 days]
The number of HCW that required hospital admission secondary to SARS-CoV-2
- Intensive care unit admissions [at any time after first dose to hospital discharge, truncated at 60 days]
The number of HCW that required intensive care unit admission
- Intubation and mechanical ventilation [at any time after first dose, truncated at 60 days]
The number of HCW that required intubation and mechanical ventilation
- ICU length of stay [from randomization to hospital discharge, truncated at 60 days]
number of days admitted to the ICU
- Hospital length of stay [from randomization to hospital discharge, truncated at 60 days]
number of days admitted to the hospital
- Mortality [from randomization to 60 days]
Death
- Incidence of adverse events [from randomization to 60 days]
Gastrointestinal symptoms (abdominal pain, diarrhea, nausea, vomiting), Hypoglycemia, Abdominal LFTs, Angioedema, Opthalmic (corneal changes, decreased visual acuity, macular degeneration, retinal changes), Bronchospasm
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years of age or older to participate.
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Healthcare workers with primary practice in intensive care unit, general internal medicine,
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COVID-19 testing centres, emergency rooms, and nursing homes.
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COVID_19 symptom free at the time of randomization and have a negative diagnostic swab.
Exclusion Criteria:
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Known COVID-19 positivity defined as: a laboratory confirmed case as defined by the local public health institutes
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Suspected COVID-19 positivity defined as possessing symptoms consistent with COVID-19 infections such as: headache, fever, nausea, vomiting, diarrhea, dyspnea, dry cough
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Healthcare workers with pre-existing retinopathy or serious visual problems
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Healthcare workers with known malignancies receiving active chemotherapy or immune modifying medications
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Healthcare workers with known autoimmune disorders
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Healthcare workers with known QT prolongation
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History of ventricular arrhythmias
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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
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Known sensitivity/allergy to hydroxychloroquine
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Healthcare workers that are currently pregnant
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Healthcare workers that are already taking chloroquine or hydroxychloroquine
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Healthcare workers on colchicine or any other anti-viral medication
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Healthcare workers taking a medication that may interact with hydroxychloroquine (see table below
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Inability to take oral medications
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Inability to provide written consent
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Known G6PD deficiency
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | St. Joseph's Healthcare Hamilton | Hamilton | Ontario | Canada | L8N 4A6 |
Sponsors and Collaborators
- St. Joseph's Healthcare Hamilton
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 3190