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: COVID-19; Clinical trial; Closed face shield; Face mask; SARS-CoV-2.
【저자키워드】 COVID-19, clinical trial, SARS-CoV-2., Face mask, Closed face shield, 【초록키워드】 Randomized controlled trial, SARS-CoV-2, Open-label, SARS-COV-2 infection, COVID-19 pandemic, Ventilation, risk, Masks, surgical, Mask, Spread, Randomized, polymerase chain reaction, SARS-CoV-2 detection, SARS-CoV-2 transmission, clinical, non-inferiority, Effectiveness, Face shield, Community, Face masks, Viral transmission, reverse transcription, Follow-up, cross, Antibody test, crowding, disease, Face mask, test result, Chain Reaction, risk difference, face, Primary outcome, intervention group, two groups, follow-up period, 95% CI, IgM antibody, participant, active control group, intention-to-treat analysis, inferiority, positive, SARS-CoV-2 test, per-protocol analysis, combined use, mitigate, Prevent, benefit, limit, setting, Randomly, polymerase chain, condition, determine, assigned, groups, highly active, 【제목키워드】 Randomized controlled trial, non-inferiority, Face shield, prevention of COVID-19,