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

Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers (PROVIDE): A Parallel Randomized Controlled Trial

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

Study Overview

• Status: Withdrawn
• Conditions: Corona Virus Infection
• Intervention / Treatment: Drug: Apo-Hydroxychloroquine; Drug: Matched Placebo

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare Hamilton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Drug: Matched Placebo; Matching Placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive for SARS-CoV-2	The number of HCW that tested positive for SARS-CoV-2	8 weeks

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): July 31, 2020
• Study Completion (Anticipated): August 30, 2020

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (Actual): May 1, 2020

Study Record Updates

• Last Update Posted (Actual): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Coronavirus Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Hydroxychloroquine
• Other Study ID Numbers: 3190

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No