Corona Virus Infection
Conditions
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
Interventions
DRUGApo-Hydroxychloroquine
Hydroxychloroquine sulfate 400mg PO BID on day one, then 400mg PO weekly, to be taken with meals for two months total.
DRUGMatched Placebo
Matching Placebo
Sponsors
St. Joseph's Healthcare Hamilton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Neither the participant, nor the investigators, study coordinators, adjudicator, and data analysts will know if the subject is receiving the hydroxychloroquine or placebo.
Intervention model description
Parallel two-armed, multi-centred, blinded, stratified, superiority, randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive for SARS-CoV-2 | 8 weeks | The number of HCW that tested positive for SARS-CoV-2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
| Hospital length of stay | from randomization to hospital discharge, truncated at 60 days | number of days admitted to the hospital |
Countries
Canada
Outcome results
None listed