Medical Masks vs N95 Respirators for COVID-19
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ClinicalTrials.gov Identifier: NCT04296643 |
Recruitment Status : Unknown
Verified March 2020 by McMaster University.
Recruitment status was: Recruiting
First Posted : March 5, 2020
Last Update Posted : February 12, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronavirus N95 Medical Mask | Device: Medical Mask Device: N95 respirator | Not Applicable |
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 |
Actual Study Start Date : | April 1, 2020 |
Estimated Primary Completion Date : | February 1, 2021 |
Estimated Study Completion Date : | April 1, 2021 |

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 |
- RT-PCR confirmed COVID-19 infection [ Time Frame: 6 months ]Number of participants with RT-PCR confirmed COVID-19 infection
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

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
Contact: Mark Loeb, MD | 9053340010 | loebm@mcmaster.ca |
Canada, Alberta | |
Foothills Medical Centre | Recruiting |
Calgary, Alberta, Canada, T2N 1N4 | |
Contact: John Conly, MD | |
Principal Investigator: John Conly, MD | |
University of Alberta Hospital | Recruiting |
Edmonton, Alberta, Canada | |
Contact: Stephanie Smith, MD | |
Principal Investigator: Stephanie Smith, MD | |
Canada, Ontario | |
Brantford General Hospital | Recruiting |
Brantford, Ontario, Canada | |
Contact: Verne Glavin, MD | |
Principal Investigator: Verne Glavin, MD | |
Hamilton Health Sciences | Recruiting |
Hamilton, Ontario, Canada | |
Contact: Dominik Mertz, MD | |
Principal Investigator: Dominik Mertz, MD | |
St. Joseph's Healthcare | Recruiting |
Hamilton, Ontario, Canada | |
Contact: Zain Chagla, MD | |
Principal Investigator: Zain Chagla, MD | |
Ottawa Hospital | Recruiting |
Ottawa, Ontario, Canada, K1H 8L6 | |
Contact: Lana Castellucci, MD | |
Principal Investigator: Lana Castellucci, MD | |
Hopital Montfort | Recruiting |
Ottawa, Ontario, Canada, K1K 0T2 | |
Contact: Sarah Mansour, MD | |
Principal Investigator: Sarah Mansour, MD | |
Niagara Health Services | Recruiting |
St. Catherines, Ontario, Canada | |
Contact: Karim Ali, MD | |
Principal Investigator: Karim Ali, MD | |
St. Joe's Unity Health | Recruiting |
Toronto, Ontario, Canada | |
Contact: Mark Downing, MD | |
Principal Investigator: Mark Downing, MD | |
St. Mike's Unity Health | Recruiting |
Toronto, Ontario, Canada | |
Contact: Matthew Muller, MD | |
Principal Investigator: Matthew Muller, MD | |
Canada, Quebec | |
Montreal University Health Centre | Recruiting |
Montréal, Quebec, Canada | |
Contact: Charles Frenette, MD | |
Principal Investigator: Charles Frenette, MD | |
The Jewish General Hospital | Recruiting |
Montréal, Quebec, Canada | |
Contact: Leighanne Parkes, MD | |
Principal Investigator: Leighanne O Parkes, MD | |
Israel | |
Golden Care LTCF | Recruiting |
Tzrifin, Israel | |
Contact: Ilan Youngster, MD | |
Principal Investigator: Ilan Youngster, MD |
Principal Investigator: | Mark B Loeb | McMaster University |
Responsible Party: | McMaster University |
ClinicalTrials.gov Identifier: | NCT04296643 |
Other Study ID Numbers: |
20006014 |
First Posted: | March 5, 2020 Key Record Dates |
Last Update Posted: | February 12, 2021 |
Last Verified: | March 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 |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Virus Diseases Infections |