History of Changes for Study: NCT04296643

Medical Masks vs N95 Respirators for COVID-19

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Study Record Versions

Version	Submitted Date	Changes
1	March 3, 2020	None (earliest Version on record)
2	November 16, 2020	Recruitment Status, Study Status, Contacts/Locations and Oversight
3	February 9, 2021	Sponsor/Collaborators and Study Status
4	December 21, 2022	Recruitment Status, Study Status, Study Design, Contacts/Locations, Outcome Measures, Study Description and Eligibility
5	January 11, 2023	Study Status and Contacts/Locations

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Study Identification


Unique Protocol ID:	20006014
Brief Title:	Medical Masks vs N95 Respirators for COVID-19
Official Title:	Medical Masks Versus N95 Respirators to Prevent 2019 Novel Coronavirus Disease (COVID-19) in Healthcare Workers: A Randomized Trial
Secondary IDs:

Study Status


Record Verification:	March 2020
Overall Status:	Recruiting
Study Start:	April 1, 2020
Primary Completion:	February 1, 2021 [Anticipated]
Study Completion:	April 1, 2021 [Anticipated]

First Submitted:	March 3, 2020
First Submitted that Met QC Criteria:	March 3, 2020
First Posted:	March 5, 2020 [Actual]

Last Update Submitted that Met QC Criteria:	November 16, 2020 February 9, 2021
Last Update Posted:	November 18, 2020 [Actual] February 12, 2021 [Actual]

Sponsor/Collaborators


Sponsor:	McMaster University
Responsible Party:	Sponsor
Collaborators:	Vancouver Coastal Health University of Alberta Dalhousie University

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

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.

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.

Conditions


Conditions:	Coronavirus N95 Medical Mask
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Prevention
Study Phase:	Not Applicable
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Single (Outcomes Assessor)
Allocation:	Randomized
Enrollment:	576 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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 [ 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


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
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/Locations


Central Contact Person:	Mark Loeb, MD Telephone: 9053340010 Email: loebm@mcmaster.ca
Study Officials:	Mark B Loeb Principal Investigator McMaster University
Locations:	Canada, Alberta
	Foothills Medical Centre [Recruiting] Calgary, Alberta, Canada, T2N 1N4 Contact:Contact: John Conly, MD Contact:Principal Investigator: John Conly, MD
	University of Alberta Hospital [Recruiting] Edmonton, Alberta, Canada Contact:Contact: Stephanie Smith, MD Contact:Principal Investigator: Stephanie Smith, MD
	Canada, Ontario
	Brantford General Hospital [Recruiting] Brantford, Ontario, Canada Contact:Contact: Verne Glavin, MD Contact:Principal Investigator: Verne Glavin, MD
	Hamilton Health Sciences [Recruiting] Hamilton, Ontario, Canada Contact:Contact: Dominik Mertz, MD Contact:Principal Investigator: Dominik Mertz, MD
	St. Joseph's Healthcare [Recruiting] Hamilton, Ontario, Canada Contact:Contact: Zain Chagla, MD Contact:Principal Investigator: Zain Chagla, MD
	Ottawa Hospital [Recruiting] Ottawa, Ontario, Canada, K1H 8L6 Contact:Contact: Lana Castellucci, MD Contact:Principal Investigator: Lana Castellucci, MD
	Hopital Montfort [Recruiting] Ottawa, Ontario, Canada, K1K 0T2 Contact:Contact: Sarah Mansour, MD Contact:Principal Investigator: Sarah Mansour, MD
	Niagara Health Services [Recruiting] St. Catherines, Ontario, Canada Contact:Contact: Karim Ali, MD Contact:Principal Investigator: Karim Ali, MD
	St. Joe's Unity Health [Recruiting] Toronto, Ontario, Canada Contact:Contact: Mark Downing, MD Contact:Principal Investigator: Mark Downing, MD
	St. Mike's Unity Health [Recruiting] Toronto, Ontario, Canada Contact:Contact: Matthew Muller, MD Contact:Principal Investigator: Matthew Muller, MD
	Canada, Quebec
	Montreal University Health Centre [Recruiting] Montréal, Quebec, Canada Contact:Contact: Charles Frenette, MD Contact:Principal Investigator: Charles Frenette, MD
	The Jewish General Hospital [Recruiting] Montréal, Quebec, Canada Contact:Contact: Leighanne Parkes, MD Contact:Principal Investigator: Leighanne O Parkes, MD
	Israel
	Golden Care LTCF [Recruiting] Tzrifin, Israel Contact:Contact: Ilan Youngster, MD Contact:Principal Investigator: Ilan Youngster, MD

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