Clinical trial NCT04371523: Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers
Official title: Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers (PROVIDE): A Parallel Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Corona Virus Infection
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel two-armed, multi-centred, blinded, stratified, superiority, randomized controlled trial
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Positive for SARS-CoV-2
timeFrame: 8 weeks
Secondary outcomes:
measure: Hospital admissions
timeFrame: at any time after first dose to hospital discharge, truncated at 60 days
measure: Intensive care unit admissions
timeFrame: at any time after first dose to hospital discharge, truncated at 60 days
measure: Intubation and mechanical ventilation
timeFrame: at any time after first dose, truncated at 60 days
measure: ICU length of stay
timeFrame: from randomization to hospital discharge, truncated at 60 days
measure: Hospital length of stay
timeFrame: from randomization to hospital discharge, truncated at 60 days
measure: Mortality
timeFrame: from randomization to 60 days
measure: Incidence of adverse events
timeFrame: from randomization to 60 days
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
References: