Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers
- Conditions
- Corona Virus Infection
- Interventions
- Drug: Apo-HydroxychloroquineDrug: Matched Placebo
- Registration Number
- NCT04371523
- Lead Sponsor
- St. Joseph's Healthcare Hamilton
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 18 years of age or older to participate.
- 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.
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Known COVID-19 positivity defined as: a laboratory confirmed case as defined by the local public health institutes
-
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
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Healthcare workers with known autoimmune disorders
-
Healthcare workers with known QT prolongation
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention - Hydroxychloroquine Apo-Hydroxychloroquine - Control Matched Placebo -
- Primary Outcome Measures
Name Time Method Positive for SARS-CoV-2 8 weeks The number of HCW that tested positive for SARS-CoV-2
- Secondary Outcome Measures
Name Time Method 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
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
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
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
Trial Locations
- Locations (1)
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada