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Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers (PROVIDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04371523
Recruitment Status : Not yet recruiting
First Posted : May 1, 2020
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Waleed Al-Hazzani, 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

Condition or disease Intervention/treatment Phase
Corona Virus Infection Drug: Apo-Hydroxychloroquine Drug: Matched Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel two-armed, multi-centred, blinded, stratified, superiority, randomized controlled trial
Masking: Quadruple (Participant, Care Provider, 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.
Primary Purpose: Prevention
Official Title: Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers (PROVIDE): A Parallel Randomized Controlled Trial
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : August 30, 2020


Arm Intervention/treatment
Experimental: Intervention - Hydroxychloroquine Drug: Apo-Hydroxychloroquine
Hydroxychloroquine sulfate 400mg PO BID on day one, then 400mg PO weekly, to be taken with meals for two months total.

Placebo Comparator: Control Drug: Matched Placebo
Matching Placebo




Primary Outcome Measures :
  1. Positive for SARS-CoV-2 [ Time Frame: 8 weeks ]
    The number of HCW that tested positive for SARS-CoV-2


Secondary Outcome Measures :
  1. Hospital admissions [ Time Frame: 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

  2. Intensive care unit admissions [ Time Frame: at any time after first dose to hospital discharge, truncated at 60 days ]
    The number of HCW that required intensive care unit admission

  3. Intubation and mechanical ventilation [ Time Frame: at any time after first dose, truncated at 60 days ]
    The number of HCW that required intubation and mechanical ventilation

  4. ICU length of stay [ Time Frame: from randomization to hospital discharge, truncated at 60 days ]
    number of days admitted to the ICU

  5. Hospital length of stay [ Time Frame: from randomization to hospital discharge, truncated at 60 days ]
    number of days admitted to the hospital

  6. Mortality [ Time Frame: from randomization to 60 days ]
    Death

  7. Incidence of adverse events [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04371523


Contacts
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Contact: Kimberley Lewis 289-775-7334 kimberley.lewis@medportal.ca
Contact: Waleed Alhazzani 905-902-2572 waleed.al-hazzani@medportal.ca

Locations
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Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
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Responsible Party: Waleed Al-Hazzani, Intensivist, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT04371523    
Other Study ID Numbers: 3190
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents