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)

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, Yenny Paola Rueda Guevara, Daniela Rodriguez Sanchez, Marcela Guevara-Suarez, Marylin Hidalgo, Paola Betancourt, 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, Yenny Paola Rueda Guevara, Daniela Rodriguez Sanchez, Marcela Guevara-Suarez, Marylin Hidalgo, Paola Betancourt

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.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Study flowchart
Fig. 2
Fig. 2
Distribution of study participants according to socioeconomic stratum, vulnerability index, and residence localities. a Vulnerability index. b Socioeconomic stratum. c Residence localities
Fig. 3
Fig. 3
Comparison of the results of the intention-to-treat and per-protocol analyses
Fig. 4
Fig. 4
Post hoc analysis

References

    1. Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect Dis. 2020;20(5):533–534. doi: 10.1016/S1473-3099(20)30120-1.
    1. Institute for Health Metrics and Evaluation (IHME). Global total deaths - COVID-19 projections. Seattle: IHME, University of Washington; 2021.
    1. Institute for Health Metrics and Evaluation (IHME) Total deaths in Latin America and Caribbean. Seattle: IHME, University of Washington; 2021.
    1. Institute for Health Metrics and Evaluation (IHME) Daily deaths in Latin America and Caribbean. Seattle: IHME, University of Washington; 2021.
    1. Institute for Health Metrics and Evaluation (IHME). Total deaths in Colombia. Seattle: IHME, University of Washington; 2021.
    1. Departamento Administrativo Nacional de Estadística - DANE . Empleo informal y seguridad social. 2020.
    1. Observatorio de la Región Bogotá . Proporción de informalidad laboral. Bogotá: Cámara de comercio de Bogotá; 2021.
    1. Bouadma L, Lescure FX, Lucet JC, Yazdanpanah Y, Timsit JF. Severe SARS-CoV-2 infections: practical considerations and management strategy for intensivists. Intensive Care Med. 2020;46(4):579–582. doi: 10.1007/s00134-020-05967-x.
    1. Centers for Disease Control and Prevention . Science brief: SARS-CoV-2 and potential airborne transmission. Atlanta: CDC; 2020.
    1. Koenig KL, Beÿ CK, McDonald EC. 2019-nCoV: the identify-isolate-inform (3I) tool applied to a novel emerging coronavirus. West J Emerg Med. 2020;21(2):184–190. doi: 10.5811/westjem.2020.1.46760.
    1. Peng X, Xu X, Li Y, Cheng L, Zhou X, Ren B. Transmission routes of 2019-nCoV and controls in dental practice. Int J Oral Sci. 2020;12(1):1–6. doi: 10.1038/s41368-020-0075-9.
    1. Rahman HS, Aziz MS, Hussein RH, Othman HH, Salih Omer SH, Khalid ES, et al. The transmission modes and sources of COVID-19: a systematic review. Int J Surg Open. 2020;26:125–136. doi: 10.1016/j.ijso.2020.08.017.
    1. World Health Organization . Coronavirus disease (COVID-19): masks. 2021.
    1. Centers for Disease Control and Prevention . Use masks to help slow spread. Atlanta: CDC; 2021.
    1. ECDC EC for DP and C . Using face masks in the community: first update - effectiveness in reducing transmission of COVID-19. 2021.
    1. Chu DK, Akl EA, Duda S, Solo K, Yaacoub S, Schünemann HJ, et al. Physical distancing, face masks, and eye protection to prevent person-to-person transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis. Lancet. 2020;395(10242):1973–1987. doi: 10.1016/S0140-6736(20)31142-9.
    1. Bundgaard H, Bundgaard JS, Raaschou-Pedersen DET, von Buchwald C, Todsen T, Norsk JB, et al. Effectiveness of adding a mask recommendation to other public health measures to prevent SARS-CoV-2 infection in Danish mask wearers. Ann Intern Med. 2021;174(3):335–343. doi: 10.7326/M20-6817.
    1. Oldfield E, Malwal SR. COVID-19 and other pandemics: how might they be prevented? ACS Infect Dis. 2020;6(7):1563–1566. doi: 10.1021/acsinfecdis.0c00291.
    1. Eikenberry SE, Mancuso M, Iboi E, Phan T, Eikenberry K, Kuang Y, et al. To mask or not to mask: modeling the potential for face mask use by the general public to curtail the COVID-19 pandemic. Infect Dis Model. 2020;5:293–308.
    1. Jefferson T, Del Mar CB, Dooley L, Ferroni E, Al-Ansary LA, Bawazeer GA, et al. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2020;11(11):CD006207.
    1. Cheng VC-C, Wong S-C, Chuang VW-M, So SY-C, Chen JH-K, Sridhar S, et al. The role of community-wide wearing of face mask for control of coronavirus disease 2019 (COVID-19) epidemic due to SARS-CoV-2. J Infect. 2020;81(1):107–114. doi: 10.1016/j.jinf.2020.04.024.
    1. Bhaskar ME, Arun S. SARS-CoV-2 infection among community health workers in India before and after use of face shields. JAMA. 2020;324(13):1348–1349. doi: 10.1001/jama.2020.15586.
    1. MacIntyre CR, Wang Q. Physical distancing, face masks, and eye protection for prevention of COVID-19. Lancet. 2020;395(10242):1950–1951. doi: 10.1016/S0140-6736(20)31183-1.
    1. Rubens JH, Karakousis PC, Jain SK. Stability and viability of SARS-CoV-2. N Engl J Med. 2020;382(20):1962–1963. doi: 10.1056/NEJMc2007942.
    1. Roberge RJ. Face shields for infection control: a review. J Occup Environ Hyg. 2016;13(4):235–242. doi: 10.1080/15459624.2015.1095302.
    1. Li DTS, Samaranayake LP, Leung YY, Neelakantan P. Facial protection in the era of COVID-19: A narrative review. Oral Dis. 2021;27(Suppl 3):665-73.
    1. Alcaldía Mayor de Bogotá. Decree 207 of 2020 by which the necessary instructions are given to preserve public order, give continuity to the eco nomic and social reactivation of Bogotá D.C. Bogotá: Secretaría General Alcaldía Mayor de Bogotá; 2020.
    1. Ewing D, Stauff JR. Yale-UNDP face shield testing. 2020.
    1. Varela AR, Florez LJH, Tamayo-Cabeza G, Contreras-Arrieta S, Restrepo SR, Laajaj R, Gutierrez GB, Guevara YPR, Caballero-Díaz Y, Florez MV, Osorio E, Barbieri IS, Sanchez DR, Nuñez LL, Bernal R, Oliveros SR, Zapata LS, Guevara-Suarez M, Uribe AG, Behrentz E. Factors associated with SARS-CoV-2 infection in Bogotá, Colombia: results from a large epidemiological surveillance study. Lancet Reg Health Am. 2021;2:100048. doi: 10.1016/j.lana.2021.100048.
    1. Food and Drug Administration . Statement on fabrication of face shields. 2020.
    1. EUR-Lex. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EE. 2017.
    1. Universidad de los Andes . Proyecto COVIDA - Boletín epidemiológico - Semana 42. Uniandes; 2021.
    1. Departamento Administrativo Nacional de Estadística - DANE. Nota metodológica Índice de vulnerabilidad por manzana. Bogotá D.C.: DANE; 2020.
    1. Ministerio de Salud y Protección Social C . Lineamientos para el uso de pruebas en el laboratorio de salud pública (LSP) en el marco de la emergencia sanitaria por (Covid-19) en Colombia. 2020.
    1. World Health Organization Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases. WHO Interim Guid. 2020;2019(January):1–7.
    1. Roche . SARS-CoV-2 rapid antibody test. 2020.
    1. Ministerio de Salud y Protección Social de Colombia. Decreto 1374 de 2020. Colombia: Ministerio de Salud y Protección Social; 2020.
    1. Fischer EP, Fischer MC, Grass D, Henrion I, Warren WS, Westman E. Low-cost measurement of face mask efficacy for filtering expelled droplets during speech. Sci Adv. 2020;6(36) Available from: . Cited 2021 Jun 3.
    1. Health WHO. Programme E. Panel EA. Preparedness IPC. Guidance IPC. Group D et al. Transmission of SARS-CoV-2: implications for infection prevention precautions. 2020. pp. 1–10.
    1. ECDC EC for DP and C . Transmission of COVID-19. 2020.
    1. Suess T, Remschmidt C, Schink SB, Schweiger B, Nitsche A, Schroeder K, et al. The role of facemasks and hand hygiene in the prevention of influenza transmission in households: results from a cluster randomised trial; Berlin, Germany, 2009–2011. BMC Infect Dis. 2012;12(1):26. doi: 10.1186/1471-2334-12-26.
    1. Prakash G, Shetty P, Thiagarajan S, Gulia A, Pandrowala S, Singh L, et al. Compliance and perception about personal protective equipment among health care workers involved in the surgery of COVID-19 negative cancer patients during the pandemic. J Surg Oncol. 2020.
    1. Samaranayake LP, Fakhruddin KS, Ngo HC, Chang JWW, Panduwawala C. The effectiveness and efficacy of respiratory protective equipment (RPE) in dentistry and other health care settings: a systematic review. Acta Odontol Scand. 2020:1–14.
    1. Simmerman JM, Suntarattiwong P, Levy J, Jarman RG, Kaewchana S, Gibbons RV, et al. Findings from a household randomized controlled trial of hand washing and face masks to reduce influenza transmission in Bangkok, Thailand. Influenza Other Respi Viruses. 2011;5(4):256–267. doi: 10.1111/j.1750-2659.2011.00205.x.
    1. Chou R, Dana T, Jungbauer R, Weeks C, McDonagh MS. Masks for prevention of respiratory virus infections, including SARS-CoV-2, in health care and community settings: a living rapid review. Ann Intern Med. 2020;173(7):542–555. doi: 10.7326/M20-3213.
    1. Rieger M. To wear or not to wear? Factors influencing wearing face masks in Germany during the COVID-19 pandemic. Soc Heal Behav. 2020;3(2):50. doi: 10.4103/SHB.SHB_23_20.
    1. Bicchieri C, Fatas E, Aldama A, Casas A, Deshpande I, Lauro M, et al. In science we (should) trust: expectations and compliance during the COVID-19 pandemic. 2020.
    1. Chaturvedi S, Gupta A, Krishnan SV, Bhat AK. Design, usage and review of a cost effective and innovative face shield in a tertiary care teaching hospital during COVID-19 pandemic. J Orthop. 2020;21:331–336. doi: 10.1016/j.jor.2020.07.003.
    1. European Centre for Disease Prevention and Control . Using face masks in the community: first update - effectiveness in reducing transmission of COVID-19. European Union; 2021.
    1. Al Naam YA, Elsafi SH, Alkharraz ZS, Alfahad OA, Al-Jubran KM, Al Zahrani EM. Community practice of using face masks for the prevention of COVID-19 in Saudi Arabia. PLoS One. 2021;16(2 February):e0247313. doi: 10.1371/journal.pone.0247313.
    1. Alsukah AI, Algadheeb NA, Almeqren MA, Alharbi FS, Alanazi RA, Alshehri AA, et al. Individuals’ self-reactions toward COVID-19 pandemic in relation to the awareness of the disease, and psychological hardiness in Saudi Arabia. Front Psychol. 2020;11:2952. doi: 10.3389/fpsyg.2020.588293.
    1. Zhang L, Tao Y, Shen M, Fairley CK, Guo Y. Can self-imposed prevention measures mitigate the COVID-19 epidemic? PLoS Med. 2020;17(7):e1003240. doi: 10.1371/journal.pmed.1003240.
    1. Parilli C, Scartascini C. A conversation with Cass Sunstein on behavioral science and using nudges: recommendations for overcoming COVID-19 - ideas matter. 2020.

Source: PubMed

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