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Clinical Efficiency of Surgical Masks and Filtering Face-piece 2 Masks

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ClinicalTrials.gov Identifier: NCT04823351
Recruitment Status : Not yet recruiting
First Posted : March 30, 2021
Last Update Posted : March 30, 2021
Sponsor:
Collaborators:
Swiss National Science Foundation
ETH Zurich
Kantonsspital Winterthur KSW
University Hospital, Zürich
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

Recent results demonstrated an increased risk of COVID-19 infection among healthcare workers (HCW), particularly when access to personal protective equipment (PPE) was inadequate. (ref). During the COVID-19 pandemic, access to PPE has become complicated by a surge in worldwide demand combined with production limitations and logistical barriers. Since their introduction in hospitals in the 1990s, filtering facepiece (FFP) masks, mostly of the FFP2 type, are used by HCWs to protect themselves against bioaerosols due to tuberculosis, measles, and selected respiratory viruses. The COVID-19 pandemic has sparked debate around reasonable and safe use of the different types of face masks to protect the HCWs who provide direct care for COVID-19 patients. At the heart of the discussion are the respective contributions to SARS-CoV-2 transmissions by droplets and aerosols, and the corresponding risk levels resulting in COVID-19 infection.

The objective is to perform a cluster-randomized, parallel, controlled, non-inferiority study among Swiss nursing and retirement homes to evaluate the efficacy of surgical masks vs. FFP2 masks during patient care and prospectively observe possible infections amongst both vaccinated and unvaccinated staff.

Staff in nursing homes will be randomized to use either surgical or FFP2 masks for patient care consistently. Considering an attack rate of 0.8% over three months among healthcare workers, a non-inferiority margin of 5%, and an intracluster variability of 0.01, - we require a minimum of 625 participants per group. The COVID-19 attack rate will be tested by initial serology testing and weekly pooled saliva specimen for SARS-CoV-2 testing. (Re)-Infections will be tracked by weekly pooled saliva-based PCR testing. Exposure to COVID-19 other than during work time will be explored by questionnaires and focus group discussions.


Condition or disease Intervention/treatment Phase
Covid19 Behavioral: Surgical Mask Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The objective is to perform a cluster-randomized, parallel, controlled, non-inferiority study among Swiss nursing and retirement homes to evaluate the efficacy of surgical masks vs. FFP2 masks during patient care and prospectively observe possible infections amongst both vaccinated and unvaccinated staff.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial to Compare Clinical Efficacy of Surgical and Filtering Facepiece 2 Masks for Care Home Workers Treating COVID-19 Patients
Estimated Study Start Date : April 8, 2021
Estimated Primary Completion Date : July 8, 2021
Estimated Study Completion Date : November 1, 2021

Arm Intervention/treatment
FFP2 Mask
Universal FFP2-masking for every healthcare worker with patient contact, compared to selective FFP2-masking, which means that FFP2 masks are worn only during aerosol-generating procedures such as tube manipulation;
Behavioral: Surgical Mask
The randomized wards will be wearing either FFP2 masks or surgical masks for 8 weeks. Then a cross-over will occur for another 8 weeks.

Surgical Mask
Universal surgical mask IIR type masking for healthcare workers in contact with COVID-19 patients.
Behavioral: Surgical Mask
The randomized wards will be wearing either FFP2 masks or surgical masks for 8 weeks. Then a cross-over will occur for another 8 weeks.




Primary Outcome Measures :
  1. SARS-CoV-2 infection [ Time Frame: 16 weeks ]
    The primary endpoint is new SARS-CoV-2 infections among healthcare workers, measured by weekly, pooled saliva specimen-based SARS-CoV-2 testing.


Secondary Outcome Measures :
  1. Exposure based on behavior [ Time Frame: 16 weeks ]
    Secondary outcomes are questionnaires on monthly activity for healthcare workers; focus group discussions on workplace vs. private exposure to COVID-19 patients. All healthcare workers are tested by serology testing at baseline. Serology testing and saliva-based PCR-testing for healthcare workers are voluntary and are performed upon written informed consent.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Study inclusion criteria;

  • Written informed consent
  • Healthcare workers at nursing homes with resident contact
  • Willingness to adhere to study protocol

Additional inclusion criteria for primary objective 2 (reinfection after vaccination)

- SARS-CoV-2 vaccination

List the study exclusion criteria:

  • Unwillingness to adhere to study protocol
  • HCW exclusively working with patients with aerosol-generating procedures during the entire study period

Information from the National Library of Medicine

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): NCT04823351


Contacts
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Contact: Michel Bielecki, MD +41798990584 michel.bielecki@uzh.ch
Contact: Walter Zingg, PD MD +41764194018 walter.zingg@usz.ch

Locations
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Switzerland
Gesundheitszentren für das Alter
Zürich, Switzerland, 8050
Contact: Heike Geschwindner, MD    +41 44 412 44 20    Heike.Geschwindner@zuerich.ch   
Sponsors and Collaborators
University of Zurich
Swiss National Science Foundation
ETH Zurich
Kantonsspital Winterthur KSW
University Hospital, Zürich
Publications:

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04823351    
Other Study ID Numbers: 4078P0_198258
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No