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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

Tracking Information
First Submitted Date  ICMJE March 3, 2020
First Posted Date  ICMJE March 5, 2020
Last Update Posted Date March 5, 2020
Estimated Study Start Date  ICMJE April 1, 2020
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2020)
RT-PCR confirmed COVID-19 infection [ Time Frame: 6 months ]
Number of participants with RT-PCR confirmed COVID-19 infection
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2020)
  • Acute respiratory illness [ Time Frame: 6 months ]
    Number of participants with acute respiratory illness
  • Absenteeism [ Time Frame: 6 months ]
    Number of participants with absenteeism
  • Lower respiratory infection [ Time Frame: 6 months ]
    Number of participants with lower respiratory infection
  • Pneumonia [ Time Frame: 6 months ]
    Number of participants with pneumonia
  • ICU admission [ Time Frame: 6 months ]
    Number of participants with ICU admission
  • Mechanical ventilation [ Time Frame: 6 months ]
    Number of participants needing mechanical ventilation
  • Death [ Time Frame: 6 months ]
    Number of participants that died
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Medical Masks vs N95 Respirators for COVID-19
Official Title  ICMJE Medical Masks Versus N95 Respirators to Prevent 2019 Novel Coronavirus Disease (COVID-19) in Healthcare Workers: A Randomized Trial
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Coronavirus
  • N95
  • Medical Mask
Intervention  ICMJE
  • Device: Medical Mask
    Medical Mask (known also as Surgical Mask)
  • Device: N95 respirator
    N95 respirator
Study Arms  ICMJE
  • Experimental: Medical Mask
    Medical Mask worn when providing care to patient with febrile respiratory illness
    Intervention: Device: Medical Mask
  • Active Comparator: N95 respirator
    N95 respirator worn when providing care to patient with febrile respiratory illness
    Intervention: Device: N95 respirator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 3, 2020)
576
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2021
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mark Loeb, MD 9053340010 loebm@mcmaster.ca
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04296643
Other Study ID Numbers  ICMJE 20006014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE
  • Vancouver Coastal Health
  • University of Alberta
  • Dalhousie University
Investigators  ICMJE
Principal Investigator: Mark B Loeb McMaster University
PRS Account McMaster University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP