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Study was not initiated due to evidence becoming available that did not support the use of hydroxychloroquine in this population, with potential risk of added harm
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The objectives of PROVIDE are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention - Hydroxychloroquine | Experimental |
| |
| Control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apo-Hydroxychloroquine | Drug | Hydroxychloroquine sulfate 400mg PO BID on day one, then 400mg PO weekly, to be taken with meals for two months total. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Positive for SARS-CoV-2 | The number of HCW that tested positive for SARS-CoV-2 | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital admissions | The number of HCW that required hospital admission secondary to SARS-CoV-2 | at any time after first dose to hospital discharge, truncated at 60 days |
| Intensive care unit admissions |
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Inclusion Criteria:
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 â—‹ 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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N 4A6 | Canada |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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Parallel two-armed, multi-centred, blinded, stratified, superiority, randomized controlled trial
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Neither the participant, nor the investigators, study coordinators, adjudicator, and data analysts will know if the subject is receiving the hydroxychloroquine or placebo.
| Matched Placebo | Drug | Matching Placebo |
|
The number of HCW that required intensive care unit admission
| 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 | at any time after first dose, truncated at 60 days |
| ICU length of stay | number of days admitted to the ICU | from randomization to hospital discharge, truncated at 60 days |
| Hospital length of stay | number of days admitted to the hospital | from randomization to hospital discharge, truncated at 60 days |
| Mortality | Death | 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 | from randomization to 60 days |
| D007239 |
| Infections |