NCT04823351

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

April 8, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

March 25, 2021

Last Update Submit

March 25, 2021

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • SARS-CoV-2 infection

    The primary endpoint is new SARS-CoV-2 infections among healthcare workers, measured by weekly, pooled saliva specimen-based SARS-CoV-2 testing.

    16 weeks

Secondary Outcomes (1)

  • Exposure based on behavior

    16 weeks

Study Arms (2)

FFP2 Mask

OTHER

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

Surgical Mask

OTHER

Universal surgical mask IIR type masking for healthcare workers in contact with COVID-19 patients.

Behavioral: Surgical Mask

Interventions

Surgical MaskBEHAVIORAL

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.

FFP2 MaskSurgical Mask

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Healthcare workers at nursing homes with resident contact
  • Willingness to adhere to study protocol
  • \- SARS-CoV-2 vaccination

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gesundheitszentren für das Alter

Zurich, 8050, Switzerland

Location

Related Publications (7)

  • Jefferson T, Del Mar CB, Dooley L, Ferroni E, Al-Ansary LA, Bawazeer GA, van Driel ML, Nair S, Jones MA, Thorning S, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2011 Jul 6;2011(7):CD006207. doi: 10.1002/14651858.CD006207.pub4.

    PMID: 21735402BACKGROUND

  • Li P, Fu JB, Li KF, Liu JN, Wang HL, Liu LJ, Chen Y, Zhang YL, Liu SL, Tang A, Tong ZD, Yan JB. Transmission of COVID-19 in the terminal stages of the incubation period: A familial cluster. Int J Infect Dis. 2020 Jul;96:452-453. doi: 10.1016/j.ijid.2020.03.027. Epub 2020 Mar 16.

    PMID: 32194239BACKGROUND

  • van Doremalen N, Bushmaker T, Morris DH, Holbrook MG, Gamble A, Williamson BN, Tamin A, Harcourt JL, Thornburg NJ, Gerber SI, Lloyd-Smith JO, de Wit E, Munster VJ. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. N Engl J Med. 2020 Apr 16;382(16):1564-1567. doi: 10.1056/NEJMc2004973. Epub 2020 Mar 17. No abstract available.

    PMID: 32182409BACKGROUND

  • Cole EC, Cook CE. Characterization of infectious aerosols in health care facilities: an aid to effective engineering controls and preventive strategies. Am J Infect Control. 1998 Aug;26(4):453-64. doi: 10.1016/s0196-6553(98)70046-x.

    PMID: 9721404BACKGROUND

  • Bourouiba L. Turbulent Gas Clouds and Respiratory Pathogen Emissions: Potential Implications for Reducing Transmission of COVID-19. JAMA. 2020 May 12;323(18):1837-1838. doi: 10.1001/jama.2020.4756. No abstract available.

    PMID: 32215590BACKGROUND

  • Wei J, Li Y. Airborne spread of infectious agents in the indoor environment. Am J Infect Control. 2016 Sep 2;44(9 Suppl):S102-8. doi: 10.1016/j.ajic.2016.06.003.

    PMID: 27590694BACKGROUND

  • Zhang X, Wang J. Dose-response Relation Deduced for Coronaviruses From Coronavirus Disease 2019, Severe Acute Respiratory Syndrome, and Middle East Respiratory Syndrome: Meta-analysis Results and its Application for Infection Risk Assessment of Aerosol Transmission. Clin Infect Dis. 2021 Jul 1;73(1):e241-e245. doi: 10.1093/cid/ciaa1675.

    PMID: 33119733BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Michel Bielecki, MD

CONTACT

+41798990584michel.bielecki@uzh.ch

Walter Zingg, PD MD

CONTACT

+41764194018walter.zingg@usz.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2021

First Posted

March 30, 2021

Study Start

April 8, 2021

Primary Completion

July 8, 2021

Study Completion

November 1, 2021

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)