The objectives of PROVIDE are to: 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Hydroxychloroquine sulfate 400mg PO BID on day one, then 400mg PO weekly, to be taken with meals for two months total.
Matching Placebo
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Positive for SARS-CoV-2
The number of HCW that tested positive for SARS-CoV-2
Time frame: 8 weeks
Hospital admissions
The number of HCW that required hospital admission secondary to SARS-CoV-2
Time frame: at any time after first dose to hospital discharge, truncated at 60 days
Intensive care unit admissions
The number of HCW that required intensive care unit admission
Time frame: at any time after first dose to hospital discharge, truncated at 60 days
Intubation and mechanical ventilation
The number of HCW that required intubation and mechanical ventilation
Time frame: at any time after first dose, truncated at 60 days
ICU length of stay
number of days admitted to the ICU
Time frame: from randomization to hospital discharge, truncated at 60 days
Hospital length of stay
number of days admitted to the hospital
Time frame: from randomization to hospital discharge, truncated at 60 days
Mortality
Death
Time frame: from randomization to 60 days
Incidence of adverse events
Gastrointestinal symptoms (abdominal pain, diarrhea, nausea, vomiting), Hypoglycemia, Abdominal LFTs, Angioedema, Opthalmic (corneal changes, decreased visual acuity, macular degeneration, retinal changes), Bronchospasm
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Time frame: from randomization to 60 days