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Medical Masks vs N95 Respirators for COVID-19

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04296643
Recruitment Status : Unknown
Verified March 2020 by McMaster University.
Recruitment status was:  Recruiting
First Posted : March 5, 2020
Last Update Posted : February 12, 2021
Sponsor:
Collaborator:
University of Alberta
Information provided by (Responsible Party):
McMaster University

Study Description
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Brief Summary:
A randomized controlled trial in which nurses will be randomized to either medical masks or N95 respirators when providing care to patients with COVID-19.

Condition or disease Intervention/treatment Phase
Coronavirus N95 Medical Mask Device: Medical Mask Device: N95 respirator Not Applicable

Detailed Description:
A randomized controlled trial in which nurses will be randomized to either medical masks or N95 respirators when providing medical care to patients with COVID-19. This Canadian multi-centre randomized controlled trial will assess whether medical masks are non-inferior to N95 respirators when nurses provide care involving non-aerosol generating procedures. Nurses will be randomized to either use of a medical mask or to a fit-tested N95 respirator when providing care for patients with febrile respiratory illness. The primary outcome is laboratory confirmed COVID-19 among nurse participants.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 576 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Medical Masks Versus N95 Respirators to Prevent 2019 Novel Coronavirus Disease (COVID-19) in Healthcare Workers: A Randomized Trial
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Medical Mask
Medical Mask worn when providing care to patient with febrile respiratory illness
 Device: Medical Mask
Medical Mask (known also as Surgical Mask)
Active Comparator: N95 respirator
N95 respirator worn when providing care to patient with febrile respiratory illness
 Device: N95 respirator
N95 respirator


Outcome Measures
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Primary Outcome Measures :
  1. RT-PCR confirmed COVID-19 infection [ Time Frame: 6 months ]
    Number of participants with RT-PCR confirmed COVID-19 infection


Secondary Outcome Measures :
  1. Acute respiratory illness [ Time Frame: 6 months ]
    Number of participants with acute respiratory illness

  2. Absenteeism [ Time Frame: 6 months ]
    Number of participants with absenteeism

  3. Lower respiratory infection [ Time Frame: 6 months ]
    Number of participants with lower respiratory infection

  4. Pneumonia [ Time Frame: 6 months ]
    Number of participants with pneumonia

  5. ICU admission [ Time Frame: 6 months ]
    Number of participants with ICU admission

  6. Mechanical ventilation [ Time Frame: 6 months ]
    Number of participants needing mechanical ventilation

  7. Death [ Time Frame: 6 months ]
    Number of participants that died


Eligibility Criteria
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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:   No
Criteria

Inclusion Criteria:

  • Nurses who work > 37 hours per week in medical, emergency, pediatric units

Exclusion Criteria:

  • Nurses with one or more comorbidities
  • Nurses who cannot pass an N95 respirator fit-test
Contacts and Locations
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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): NCT04296643


Contacts
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Contact: Mark Loeb, MD 9053340010 loebm@mcmaster.ca

Locations
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Canada, Alberta
Foothills Medical Centre Recruiting
Calgary, Alberta, Canada, T2N 1N4
Contact: John Conly, MD         
Principal Investigator: John Conly, MD         
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada
Contact: Stephanie Smith, MD         
Principal Investigator: Stephanie Smith, MD         
Canada, Ontario
Brantford General Hospital Recruiting
Brantford, Ontario, Canada
Contact: Verne Glavin, MD         
Principal Investigator: Verne Glavin, MD         
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada
Contact: Dominik Mertz, MD         
Principal Investigator: Dominik Mertz, MD         
St. Joseph's Healthcare Recruiting
Hamilton, Ontario, Canada
Contact: Zain Chagla, MD         
Principal Investigator: Zain Chagla, MD         
Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Lana Castellucci, MD         
Principal Investigator: Lana Castellucci, MD         
Hopital Montfort Recruiting
Ottawa, Ontario, Canada, K1K 0T2
Contact: Sarah Mansour, MD         
Principal Investigator: Sarah Mansour, MD         
Niagara Health Services Recruiting
St. Catherines, Ontario, Canada
Contact: Karim Ali, MD         
Principal Investigator: Karim Ali, MD         
St. Joe's Unity Health Recruiting
Toronto, Ontario, Canada
Contact: Mark Downing, MD         
Principal Investigator: Mark Downing, MD         
St. Mike's Unity Health Recruiting
Toronto, Ontario, Canada
Contact: Matthew Muller, MD         
Principal Investigator: Matthew Muller, MD         
Canada, Quebec
Montreal University Health Centre Recruiting
Montréal, Quebec, Canada
Contact: Charles Frenette, MD         
Principal Investigator: Charles Frenette, MD         
The Jewish General Hospital Recruiting
Montréal, Quebec, Canada
Contact: Leighanne Parkes, MD         
Principal Investigator: Leighanne O Parkes, MD         
Israel
Golden Care LTCF Recruiting
Tzrifin, Israel
Contact: Ilan Youngster, MD         
Principal Investigator: Ilan Youngster, MD         
Sponsors and Collaborators
McMaster University
University of Alberta
Investigators
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Principal Investigator: Mark B Loeb McMaster University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT04296643    
Other Study ID Numbers: 20006014
First Posted: March 5, 2020    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Virus Diseases
Infections