PROVIDE: Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers

Sponsor
St. Joseph's Healthcare Hamilton (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04371523
Collaborator
(none)
0
1
2
4
0

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel two-armed, multi-centred, blinded, stratified, superiority, randomized controlled trialParallel 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
Anticipated Study Start Date :
May 1, 2020
Anticipated Primary Completion Date :
Jul 31, 2020
Anticipated Study Completion Date :
Aug 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Positive for SARS-CoV-2 [8 weeks]

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

Secondary Outcome Measures

  1. 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

  2. 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

  3. Intubation and mechanical ventilation [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 [from randomization to hospital discharge, truncated at 60 days]

    number of days admitted to the ICU

  5. Hospital length of stay [from randomization to hospital discharge, truncated at 60 days]

    number of days admitted to the hospital

  6. Mortality [from randomization to 60 days]

    Death

  7. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Joseph's Healthcare Hamilton Hamilton Ontario Canada L8N 4A6

Sponsors and Collaborators

  • St. Joseph's Healthcare Hamilton

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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
Last Update Posted:
Sep 27, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 27, 2021