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History of Changes for Study: NCT04296643
Medical Masks vs N95 Respirators for COVID-19
Latest version (submitted January 11, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B 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
Comparison Format:

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Changes (Merged) for Study: NCT04296643
November 16, 2020 (v2) -- January 11, 2023 (v5)

Changes in: Study Status, Sponsor/Collaborators, Study Description, Study Design, Outcome Measures, Eligibility and Contacts/Locations

Open or close this module 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:
Open or close this module Study Status
Record Verification: March 2020 January 2023
Overall Status: Recruiting Completed
Study Start: April March 1, 2020
Primary Completion: February 1, 2021 [Anticipated] June 1, 2022 [Actual]
Study Completion: April 1, 2021 [Anticipated] December 8, 2022 [Actual]
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 January 11, 2023
Last Update Posted: November 18, 2020 [Actual] January 12, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: McMaster University
Responsible Party: Sponsor
Collaborators: Vancouver Coastal Health
University of Alberta
Dalhousie University
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: A randomized controlled trial in which nurses health care workers 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 health care workers 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 health care workers provide care involving non-aerosol generating procedures. Nurses Health care workers 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. Health care workers randomly assigned to the N95 respirator group will be instructed to use a fit-tested National Institute for Occupational Safety and Health-approved N95 respirator when providing routine care to patients with COVID-19 or suspected COVID-19. Participants will use the type of device they were allocated to, either a medical mask or an N95 respirator, for 10 weeks, however, health care workers can also use the N95 respirator at any time based on a point-of-care risk assessment. Universal masking is the policy implemented at each study site. Extended and re-use of N95 respirators will be permitted if the local situation requires it. The primary outcome is laboratory confirmed RT-PCR COVID-19 among nurse participants.

A nasopharyngeal swab will be obtained if any one of the following symptoms or signs is present: fever (≥38 C), cough, or shortness of breath, or if 2 of the following are present: fatigue, myalgia, headache, dizziness, expectoration, sore throat, diarrhea, nausea, vomiting, abdominal pain, runny nose, altered taste or smell, conjunctivitis, or painful swallowing.

Participants that receive a COVID-19 vaccine after enrollment with efficacy of > 50% for the circulating strain will continue to be followed until 2 weeks after the first dose of the vaccine. All other participants will be followed for 10 weeks.

Self-reporting of hand hygiene and the use of external monitors, where feasible, will be used to collect basic hand hygiene data.

The sample size is 1,010 participants. This will allow 90% power at an alpha (one sided) of 0.05 and to account for participants who may not have completed 10 weeks because of COVID-19 mRNA vaccination.

Changes made to the protocol prior to May 4, 2020, which was prior to the start of enrollment:

  • Eligibility criteria expanded from nurses who provide direct patient care to health care workers that provide direct patient care.
  • Allowed extended and re-use of N95 respirators if the local situation required it.
  • Added self-reporting of hand hygiene and the use of external monitors if feasible.
  • Reduced the duration of follow up from 12 weeks to 10 weeks

Changes made on or after May 4, 2020:

  • Expanded the criteria for the requirement of swabs to detect COVID-19 by adding runny nose, altered taste or smell, and conjunctivitis and also asked for a swab for fever, cough, or shortness of breath alone OR for two of the previously listed symptoms or signs (May 19, 2020).
  • Added previously known COVID infection as an exclusion (October, 30, 2020).
  • Added receipt of a COVID-19 vaccine with efficacy of > 50% as an exclusion (October 30, 2020).
  • Allowed those participants that received a COVID-19 vaccine after enrollment with efficacy of > 50% for the circulating strain to continue to be followed until 2 weeks after the first dose of the vaccine (December 17, 2020).
  • Increased the sample size to 1,010 participants to allow 90% power at an alpha (one sided) of 0.05 and to account for participants who may not have completed 10 weeks because of COVID-19 mRNA vaccination (July 26, 2021).
  • Added wording to capture implementation since May 4th, 2020, "Where the policy of the healthcare setting has been universal use of a facemask, that is wearing a facemask at all times when in the hospital, then the facemask participants were randomized to will be used." (December 27, 2021)
Open or close this module Conditions
Conditions: Coronavirus
N95
Medical Mask
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Not Applicable Phase 4
Interventional Study Model: Parallel Assignment
pragmatic, randomized, open-label, multicentre, noninferiority trial.
Number of Arms: 2
Masking: Single Double (Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 576 [Anticipated] 1009 [Actual]
Open or close this module 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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. RT-PCR confirmed COVID-19 infection
[ Time Frame: 6 months 10 weeks ]

Number of participants with RT-PCR confirmed COVID-19 infection
Secondary Outcome Measures:
1. Acute respiratory illness
[ Time Frame: 6 months 10 weeks ]

Number of participants with acute respiratory illness
2. Absenteeism
[ Time Frame: 6 months 10 weeks ]

Number of participants with absenteeism
3. Lower respiratory infection
[ Time Frame: 6 months 10 weeks ]

Number of participants with lower respiratory infection
4. Pneumonia
[ Time Frame: 6 months 10 weeks ]

Number of participants with pneumonia
5. ICU admission
[ Time Frame: 6 months 10 weeks ]

Number of participants with ICU admission
6. Mechanical ventilation
[ Time Frame: 6 months 10 weeks ]

Number of participants needing mechanical ventilation
7. Death
[ Time Frame: 6 months 10 weeks ]

Number of participants that died
Open or close this module 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 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.

Exclusion Criteria:

  • 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.
  • Nurses with one or more comorbidities
  • Nurses who cannot pass an N95 respirator fit-test
Open or close this module 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
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 1N4
University of Alberta Hospital
[Recruiting]
Edmonton, Alberta, Canada
Contact:Contact: Stephanie Smith, MD
Contact:Principal Investigator: Stephanie Smith, MD
University of Alberta Hospital
Edmonton, Alberta, Canada
Canada, Ontario
Brantford General Hospital
[Recruiting]
Brantford, Ontario, Canada
Contact:Contact: Verne Glavin, MD
Contact:Principal Investigator: Verne Glavin, MD
Brantford General Hospital
Brantford, Ontario, Canada
Hamilton Health Sciences
[Recruiting]
Hamilton, Ontario, Canada
Contact:Contact: Dominik Mertz, MD
Contact:Principal Investigator: Dominik Mertz, MD
Hamilton Health Sciences
Hamilton, Ontario, Canada
St. Joseph's Healthcare
[Recruiting]
Hamilton, Ontario, Canada
Contact:Contact: Zain Chagla, MD
Contact:Principal Investigator: Zain Chagla, MD
St. Joseph's Healthcare
Hamilton, Ontario, Canada
Ottawa Hospital
[Recruiting]
Ottawa, Ontario, Canada, K1H 8L6
Contact:Contact: Lana Castellucci, MD
Contact:Principal Investigator: Lana Castellucci, MD
Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Hopital Montfort
[Recruiting]
Ottawa, Ontario, Canada, K1K 0T2
Contact:Contact: Sarah Mansour, MD
Contact:Principal Investigator: Sarah Mansour, MD
Hopital Montfort
Ottawa, Ontario, Canada, K1K 0T2
Niagara Health Services
[Recruiting]
St. Catherines, Ontario, Canada
Contact:Contact: Karim Ali, MD
Contact:Principal Investigator: Karim Ali, MD
Niagara Health Services
St. Catherines, Ontario, Canada
St. Joe's Unity Health
[Recruiting]
Toronto, Ontario, Canada
Contact:Contact: Mark Downing, MD
Contact:Principal Investigator: Mark Downing, MD
St. Joe's Unity Health
Toronto, Ontario, Canada
St. Mike's Unity Health
[Recruiting]
Toronto, Ontario, Canada
Contact:Contact: Matthew Muller, MD
Contact:Principal Investigator: Matthew Muller, MD
St. Mike's Unity Health
Toronto, Ontario, Canada
Canada, Quebec
Montreal University Health Centre
[Recruiting]
Montréal, Quebec, Canada
Contact:Contact: Charles Frenette, MD
Contact:Principal Investigator: Charles Frenette, MD
Montreal University Health Centre
Montréal, Quebec, Canada
The Jewish General Hospital
[Recruiting]
Montréal, Quebec, Canada
Contact:Contact: Leighanne Parkes, MD
Contact:Principal Investigator: Leighanne O Parkes, MD
The Jewish General Hospital
Montréal, Quebec, Canada
Egypt
Fayoum General Hospital
Fayoum, Egypt
Israel
Golden Care LTCF
[Recruiting]
Tzrifin, Israel
Contact:Contact: Ilan Youngster, MD
Contact:Principal Investigator: Ilan Youngster, MD
Golden Care LTCF
Tzrifin, Israel
Pakistan
Dr. Ziauddin Hospital
Karachi, Pakistan
Open or close this module IPDSharing
Plan to Share IPD:
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Available IPD/Information:

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