Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers

NCT04371523 | Withdrawn Phase 3 DMC

• 1 other identifier: 3190
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of PROVIDE are to:

1. 1.Determine if prophylactic once weekly hydroxychloroquine reduces the incidence of conversion from SARS-2-CoVnasopharyngeal swab negative to positive
2. 2.To determine if weekly prophylactic hydroxychloroquine reduced the severity of COVID-19 symptoms
3. 3.To determine the safety of taking weekly prophylactic hydroxychloroquine

Conditions

Corona Virus Infection

Outcome Measures

Primary Outcomes (1)

• Positive for SARS-CoV-2

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

  8 weeks

Secondary Outcomes (7)

• Hospital admissions

  at any time after first dose to hospital discharge, truncated at 60 days

• Intensive care unit admissions

  at any time after first dose to hospital discharge, truncated at 60 days

• Intubation and mechanical ventilation

  at any time after first dose, truncated at 60 days

• ICU length of stay

  from randomization to hospital discharge, truncated at 60 days

• Hospital length of stay

  from randomization to hospital discharge, truncated at 60 days

Study Arms (2)

Intervention - Hydroxychloroquine

EXPERIMENTAL

Drug: Apo-Hydroxychloroquine

Control

PLACEBO COMPARATOR

Drug: Matched Placebo

Interventions

Apo-Hydroxychloroquine DRUG

Hydroxychloroquine sulfate 400mg PO BID on day one, then 400mg PO weekly, to be taken with meals for two months total.

Intervention - Hydroxychloroquine

Matched Placebo DRUG

Matching Placebo

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither the participant, nor the investigators, study coordinators, adjudicator, and data analysts will know if the subject is receiving the hydroxychloroquine or placebo.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intensivist

Model Details: Parallel two-armed, multi-centred, blinded, stratified, superiority, randomized controlled trial

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 1, 2020
• Study Start: May 1, 2020
• Primary Completion: July 31, 2020
• Study Completion: August 30, 2020
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)