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

Primary Purpose

Corona Virus Infection

Status
Withdrawn
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Apo-Hydroxychloroquine
Matched Placebo
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Corona Virus Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • St. Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention - Hydroxychloroquine

Control

Arm Description

Outcomes

Primary Outcome Measures

Positive for SARS-CoV-2
The number of HCW that tested positive for SARS-CoV-2

Secondary Outcome Measures

Hospital admissions
The number of HCW that required hospital admission secondary to SARS-CoV-2
Intensive care unit admissions
The number of HCW that required intensive care unit admission
Intubation and mechanical ventilation
The number of HCW that required intubation and mechanical ventilation
ICU length of stay
number of days admitted to the ICU
Hospital length of stay
number of days admitted to the hospital
Mortality
Death
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

Full Information

First Posted
April 28, 2020
Last Updated
September 21, 2021
Sponsor
St. Joseph's Healthcare Hamilton
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1. Study Identification

Unique Protocol Identification Number
NCT04371523
Brief Title
Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers
Acronym
PROVIDE
Official Title
Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers (PROVIDE): A Parallel Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
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
Study Start Date
May 1, 2020 (Anticipated)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
August 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objectives of PROVIDE are to: Determine if prophylactic once weekly hydroxychloroquine reduces the incidence of conversion from SARS-2-CoVnasopharyngeal swab negative to positive To determine if weekly prophylactic hydroxychloroquine reduced the severity of COVID-19 symptoms To determine the safety of taking weekly prophylactic hydroxychloroquine

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corona Virus Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel two-armed, multi-centred, blinded, stratified, superiority, randomized controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention - Hydroxychloroquine
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Apo-Hydroxychloroquine
Intervention Description
Hydroxychloroquine sulfate 400mg PO BID on day one, then 400mg PO weekly, to be taken with meals for two months total.
Intervention Type
Drug
Intervention Name(s)
Matched Placebo
Intervention Description
Matching Placebo
Primary Outcome Measure Information:
Title
Positive for SARS-CoV-2
Description
The number of HCW that tested positive for SARS-CoV-2
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Hospital admissions
Description
The number of HCW that required hospital admission secondary to SARS-CoV-2
Time Frame
at any time after first dose to hospital discharge, truncated at 60 days
Title
Intensive care unit admissions
Description
The number of HCW that required intensive care unit admission
Time Frame
at any time after first dose to hospital discharge, truncated at 60 days
Title
Intubation and mechanical ventilation
Description
The number of HCW that required intubation and mechanical ventilation
Time Frame
at any time after first dose, truncated at 60 days
Title
ICU length of stay
Description
number of days admitted to the ICU
Time Frame
from randomization to hospital discharge, truncated at 60 days
Title
Hospital length of stay
Description
number of days admitted to the hospital
Time Frame
from randomization to hospital discharge, truncated at 60 days
Title
Mortality
Description
Death
Time Frame
from randomization to 60 days
Title
Incidence of adverse events
Description
Gastrointestinal symptoms (abdominal pain, diarrhea, nausea, vomiting), Hypoglycemia, Abdominal LFTs, Angioedema, Opthalmic (corneal changes, decreased visual acuity, macular degeneration, retinal changes), Bronchospasm
Time Frame
from randomization to 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers

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