Randomized Controlled Trial to Compare Clinical Efficacy of Surgical and Filtering Facepiece 2 Masks for Care Home Workers Treating COVID-19 Patients

Status: Unknown
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• Written informed consent

• Healthcare workers at nursing homes with resident contact

• Willingness to adhere to study protocol

⁃ \- SARS-CoV-2 vaccination

Locations
Other Locations
Switzerland
Gesundheitszentren für das Alter
Zurich
Contact Information
Primary
Michel Bielecki, MD
michel.bielecki@uzh.ch
+41798990584
Backup
Walter Zingg, PD MD
walter.zingg@usz.ch
+41764194018
Time Frame
Start Date: 2021-04-08
Completion Date: 2021-11-01
Participants
Target number of participants: 1200
Treatments
Other: 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;
Other: Surgical Mask
Universal surgical mask IIR type masking for healthcare workers in contact with COVID-19 patients.
Related Therapeutic Areas
Sponsors
Collaborators: Swiss National Science Foundation, Kantonsspital Winterthur KSW, ETH Zurich, University Hospital, Zürich
Leads: University of Zurich

This content was sourced from clinicaltrials.gov