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Medical Masks vs N95 Respirators for COVID-19

Sponsor
McMaster University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04296643
Collaborator
University of Alberta (Other)
576
Enrollment
13
Locations
2
Arms
12
Anticipated Duration (Months)
44.3
Patients Per Site
3.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Medical Mask
  • Device: N95 respirator
 N/A

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

Study Type:
Interventional
Anticipated 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 :
Apr 1, 2020
Anticipated Primary Completion Date :
Feb 1, 2021
Anticipated Study Completion Date :
Apr 1, 2021

Arms and Interventions

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

Primary Outcome Measures

  1. RT-PCR confirmed COVID-19 infection [6 months]

    Number of participants with RT-PCR confirmed COVID-19 infection

Secondary Outcome Measures

  1. Acute respiratory illness [6 months]

    Number of participants with acute respiratory illness

  2. Absenteeism [6 months]

    Number of participants with absenteeism

  3. Lower respiratory infection [6 months]

    Number of participants with lower respiratory infection

  4. Pneumonia [6 months]

    Number of participants with pneumonia

  5. ICU admission [6 months]

    Number of participants with ICU admission

  6. Mechanical ventilation [6 months]

    Number of participants needing mechanical ventilation

  7. Death [6 months]

    Number of participants that died

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Foothills Medical Centre Calgary Alberta Canada T2N 1N4
2 University of Alberta Hospital Edmonton Alberta Canada
3 Brantford General Hospital Brantford Ontario Canada
4 Hamilton Health Sciences Hamilton Ontario Canada
5 St. Joseph's Healthcare Hamilton Ontario Canada
6 Ottawa Hospital Ottawa Ontario Canada K1H 8L6
7 Hopital Montfort Ottawa Ontario Canada K1K 0T2
8 Niagara Health Services St. Catherines Ontario Canada
9 St. Joe's Unity Health Toronto Ontario Canada
10 St. Mike's Unity Health Toronto Ontario Canada
11 Montreal University Health Centre Montréal Quebec Canada
12 The Jewish General Hospital Montréal Quebec Canada
13 Golden Care LTCF Tzrifin Israel

Sponsors and Collaborators

  • McMaster University
  • University of Alberta

Investigators

  • Principal Investigator: Mark B Loeb, McMaster University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
McMaster University
ClinicalTrials.gov Identifier:
NCT04296643
Other Study ID Numbers:
  • 20006014
First Posted:
Mar 5, 2020
Last Update Posted:
Feb 12, 2021
Last Verified:
Mar 1, 2020
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:
Coronavirus Infections

Study Results

No Results Posted as of Feb 12, 2021