Medical Masks vs N95 Respirators for COVID-19

• ClinicalTrials.gov Identifier: NCT04296643
• Recruitment Status: Completed
• First Posted: March 5, 2020
• Last Update Posted: January 12, 2023
• Sponsor: McMaster University
• Collaborator: University of Alberta
• Information provided by (Responsible Party): McMaster University

Tracking Information

• First Submitted Date: March 3, 2020
• First Posted Date: March 5, 2020
• Last Update Posted Date: January 12, 2023
• Actual Study Start Date: March 1, 2020
• Actual Primary Completion Date: June 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 21, 2022)

RT-PCR confirmed COVID-19 infection [ Time Frame: 10 weeks ]

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

Original Primary Outcome Measures (submitted: March 3, 2020)

RT-PCR confirmed COVID-19 infection [ Time Frame: 6 months ]

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

Current Secondary Outcome Measures (submitted: December 21, 2022)

• Acute respiratory illness [ Time Frame: 10 weeks ]
  Number of participants with acute respiratory illness
• Absenteeism [ Time Frame: 10 weeks ]
  Number of participants with absenteeism
• Lower respiratory infection [ Time Frame: 10 weeks ]
  Number of participants with lower respiratory infection
• Pneumonia [ Time Frame: 10 weeks ]
  Number of participants with pneumonia
• ICU admission [ Time Frame: 10 weeks ]
  Number of participants with ICU admission
• Mechanical ventilation [ Time Frame: 10 weeks ]
  Number of participants needing mechanical ventilation
• Death [ Time Frame: 10 weeks ]
  Number of participants that died

Original Secondary Outcome Measures (submitted: March 3, 2020)

• 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

Detailed Description

A randomized controlled trial in which health care workers will be randomized to either medical masks or N95 respirators when providing medical care to patients with COVID-19. This multi-centre randomized controlled trial will assess whether medical masks are non-inferior to N95 respirators when health care workers provide care involving non-aerosol generating procedures. 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 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)

• Study Type: Interventional
• Study Phase: Phase 4

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

pragmatic, randomized, open-label, multicentre, noninferiority trial.

Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Prevention

Condition

• Coronavirus
• N95
• Medical Mask

Intervention

• Device: Medical Mask
  Medical Mask (known also as Surgical Mask)
• Device: N95 respirator
  N95 respirator

Study Arms

• Experimental: Medical Mask
  Medical Mask worn when providing care to patient with febrile respiratory illness
  Intervention: Device: Medical Mask
• Active Comparator: N95 respirator
  N95 respirator worn when providing care to patient with febrile respiratory illness
  Intervention: Device: N95 respirator

• Publications *: Schunemann 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 21, 2022): 1009
• Original Estimated Enrollment (submitted: March 3, 2020): 576
• Actual Study Completion Date: December 8, 2022
• Actual Primary Completion Date: June 1, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, Egypt, Israel, Pakistan

Administrative Information

• NCT Number: NCT04296643
• Other Study ID Numbers: 20006014
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: McMaster University
• Original Responsible Party: Same as current
• Current Study Sponsor: McMaster University
• Original Study Sponsor: Same as current
• Collaborators: University of Alberta

Investigators

• Principal Investigator: Mark B Loeb; McMaster University

• PRS Account: McMaster University
• Verification Date: January 2023