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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04296643
Recruitment Status : Not yet recruiting
First Posted : March 5, 2020
Last Update Posted : March 5, 2020
Sponsor:
Collaborators:
Vancouver Coastal Health
University of Alberta
Dalhousie University
Information provided by (Responsible Party):
McMaster University

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.

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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
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


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




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



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

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

Sponsors and Collaborators
McMaster University
Vancouver Coastal Health
University of Alberta
Dalhousie University
Investigators
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Principal Investigator: Mark B Loeb McMaster University
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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: March 5, 2020
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