Effectiveness and Adherence to Closed Face Shields in the Prevention of COVID-19 Transmission: A Non-inferiority Randomized Controlled Trial in a Middle-Income Setting (COVPROSHIELD)

Authors

Andrea Ramirez Varela
Alejandro Pacheco Gurruchaga
Silvia Restrepo Restrepo
Juan David Martin
Yessica Daniela Campaz Landazabal
Guillermo Tamayo-Cabeza
Sandra Contreras-Arrieta
Yuldor Caballero-Díaz
Luis Jorge Hernandez Florez
John Mario González
Juan Carlos Santos-Barbosa
José David Pinzón
Juan José Yepes-Nuñez
Rachid Laajaj
Giancarlo Buitrago Gutierrez
Martha Vives Florez
Janner Fuentes Castillo
Gianni Quinche Vargas
Andres Casas
Antonio Medina
Eduardo Behrentz
CoVIDA Working Group

Publication Date

8-20-2022

Journal

Trials

Abstract

BACKGROUND: The use of respiratory devices can mitigate the spread of diseases such as COVID-19 in community settings. We aimed to determine the effectiveness of closed face shields with surgical face masks to prevent SARS-CoV-2 transmission in working adults during the COVID-19 pandemic in Bogotá, Colombia.

METHODS: An open-label non-inferiority randomized controlled trial that randomly assigned participants to one of two groups: the intervention group was instructed to wear closed face shields with surgical face masks, and the active control group was instructed to wear only surgical face masks. The primary outcome was a positive reverse transcription polymerase chain reaction test, IgG/IgM antibody test for SARS-CoV-2 detection, or both during and at the end of the follow-up period of 21 days. The non-inferiority limit was established at - 5%.

RESULTS: A total of 316 participants were randomized, 160 participants were assigned to the intervention group and 156 to the active control group. In total, 141 (88.1%) participants in the intervention group and 142 (91.0%) in the active control group completed the follow-up.

PRIMARY OUTCOME: a positive SARS-CoV-2 test result was identified in one (0.71%) participant in the intervention group and three (2.1%) in the active control group. In the intention-to-treat analysis, the absolute risk difference was - 1.40% (95% CI [- 4.14%, 1.33%]), and in the per-protocol analysis, the risk difference was - 1.40% (95% CI [- 4.20, 1.40]), indicating non-inferiority of the closed face shield plus face mask (did not cross the non-inferiority limit).

CONCLUSIONS: The use of closed face shields and surgical face masks was non-inferior to the surgical face mask alone in the prevention of SARS-CoV-2 infection in highly exposed groups. Settings with highly active viral transmission and conditions such as poor ventilation, crowding, and high mobility due to occupation may benefit from the combined use of masks and closed face shields to mitigate SARS-CoV-2 transmission.

TRIAL REGISTRATION: ClinicalTrials.gov NCT04647305 . Registered on November 30, 2020.

Keywords

Adult, COVID-19, Humans, Masks, Pandemics, Risk Assessment, SARS-CoV-2

Comments

Supplementary Materials

PMID: 35987694