Medical Masks vs N95 Respirators for COVID-19
Medical Masks Versus N95 Respirators to Prevent 2019 Novel Coronavirus Disease (COVID-19) in Healthcare Workers: A Randomized Trial
1 other identifier
interventional
1,009
4 countries
15
Brief Summary
A randomized controlled trial in which health care workers will be randomized to either medical masks or N95 respirators when providing care to patients with COVID-19.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2020
Typical duration for phase_4
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2020
CompletedFirst Submitted
Initial submission to the registry
March 3, 2020
CompletedFirst Posted
Study publicly available on registry
March 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2022
CompletedJanuary 12, 2023
January 1, 2023
2.3 years
March 3, 2020
January 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
RT-PCR confirmed COVID-19 infection
Number of participants with RT-PCR confirmed COVID-19 infection
10 weeks
Secondary Outcomes (7)
Acute respiratory illness
10 weeks
Absenteeism
10 weeks
Lower respiratory infection
10 weeks
Pneumonia
10 weeks
ICU admission
10 weeks
- +2 more secondary outcomes
Study Arms (2)
Medical Mask
EXPERIMENTALMedical Mask worn when providing care to patient with febrile respiratory illness
N95 respirator
ACTIVE COMPARATORN95 respirator worn when providing care to patient with febrile respiratory illness
Interventions
Eligibility Criteria
You may qualify if:
- Health care workers who provide direct care to patients with suspected or confirmed COVID-19 in specialized COVID-19 units and in emergency departments, medical units, pediatric units, and long-term care facilities
- Health care workers are required to spend 60% or more of their time doing clinical work when enrolled.
You may not qualify if:
- Unable to pass or do not have a valid fit test within the past 24 months
- One or more high-risk comorbidities for COVID-19 (hypertension, cardiac disease, pulmonary disease, chronic kidney disease, diabetes, chronic liver disease, actively treated cancer, or immunosuppression due to illness or medications)
- Previous laboratory confirmed clinical diagnosis of COVID-19 at the time of
- Received 1 or more doses of a COVID-19 vaccine with greater than 50% efficacy for the circulating strain (for example, mRNA or vector-based COVID-19 vaccine against the original SARS-CoV-2 strain).
- working in intensive care units.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McMaster Universitylead
- University of Albertacollaborator
Study Sites (15)
Foothills Medical Centre
Calgary, Alberta, T2N 1N4, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Brantford General Hospital
Brantford, Ontario, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
St. Joseph's Healthcare
Hamilton, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Hopital Montfort
Ottawa, Ontario, K1K 0T2, Canada
Niagara Health Services
Saint Catherines, Ontario, Canada
St. Joe's Unity Health
Toronto, Ontario, Canada
St. Mike's Unity Health
Toronto, Ontario, Canada
Montreal University Health Centre
Montreal, Quebec, Canada
The Jewish General Hospital
Montreal, Quebec, Canada
Fayoum General Hospital
Al Fayyum, Egypt
Golden Care LTCF
Tzrifin, Israel
Dr. Ziauddin Hospital
Karachi, Pakistan
Related Publications (2)
Loeb M, Bartholomew A, Hashmi M, Tarhuni W, Hassany M, Youngster I, Somayaji R, Larios O, Kim J, Missaghi B, Vayalumkal JV, Mertz D, Chagla Z, Cividino M, Ali K, Mansour S, Castellucci LA, Frenette C, Parkes L, Downing M, Muller M, Glavin V, Newton J, Hookoom R, Leis JA, Kinross J, Smith S, Borhan S, Singh P, Pullenayegum E, Conly J. Medical Masks Versus N95 Respirators for Preventing COVID-19 Among Health Care Workers : A Randomized Trial. Ann Intern Med. 2022 Dec;175(12):1629-1638. doi: 10.7326/M22-1966. Epub 2022 Nov 29.
PMID: 36442064DERIVEDSchunemann HJ, Akl EA, Chou R, Chu DK, Loeb M, Lotfi T, Mustafa RA, Neumann I, Saxinger L, Sultan S, Mertz D. Use of facemasks during the COVID-19 pandemic. Lancet Respir Med. 2020 Oct;8(10):954-955. doi: 10.1016/S2213-2600(20)30352-0. Epub 2020 Aug 3. No abstract available.
PMID: 32758441DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark B Loeb
McMaster University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Investigators and laboratory assessors were blinded to the group assignment, but it was not possible to conceal the identity of the medical mask or N95 respirator assignment to the study staff or participants.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2020
First Posted
March 5, 2020
Study Start
March 1, 2020
Primary Completion
June 1, 2022
Study Completion
December 8, 2022
Last Updated
January 12, 2023
Record last verified: 2023-01