Faculty of Medicine, Universidad de los Andes, Cra 7 #116-05, Bogotá, 11001000, Colombia.
United Nations Development Programme (UNDP), Bogota, Colombia.
Trials. 2022 Aug 20;23(1):698. doi: 10.1186/s13063-022-06606-0.
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.
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%.
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.
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).
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.
ClinicalTrials.gov NCT04647305 . Registered on November 30, 2020.
在社区环境中，使用呼吸设备可以减轻 COVID-19 等疾病的传播。我们旨在确定在哥伦比亚波哥大 COVID-19 大流行期间，对于工作成年人，使用带外科口罩的封闭式面罩来预防 SARS-CoV-2 传播的效果。
这是一项开放标签、非劣效性随机对照试验，将参与者随机分配至两组：干预组被指示佩戴带外科口罩的封闭式面罩，而活性对照组则被指示仅佩戴外科口罩。主要结局是在 21 天的随访期间和结束时，进行 SARS-CoV-2 检测的逆转录聚合酶链反应（RT-PCR）阳性检测、IgG/IgM 抗体检测或两者均呈阳性。非劣效性界限设定为-5%。
共有 316 名参与者被随机分配，160 名参与者被分配至干预组，156 名参与者被分配至活性对照组。共有 141 名（88.1%）干预组参与者和 142 名（91.0%）活性对照组参与者完成了随访。
干预组中有 1 名（0.71%）参与者和活性对照组中有 3 名（2.1%）参与者的 SARS-CoV-2 检测结果呈阳性。在意向治疗分析中，绝对风险差异为-1.40%（95%CI[-4.14%,1.33%]），而在方案治疗分析中，风险差异为-1.40%（95%CI[-4.20,1.40]），表明封闭式面罩加口罩的使用不劣于单独使用外科口罩（未越过非劣效性界限）。
在高度暴露人群中，使用封闭式面罩和外科口罩预防 SARS-CoV-2 感染不劣于单独使用外科口罩。在病毒传播高度活跃、通风不良、人员拥挤以及因职业原因流动性高的环境中，口罩和封闭式面罩联合使用可能有助于减轻 SARS-CoV-2 的传播。
ClinicalTrials.gov NCT04647305。于 2020 年 11 月 30 日注册。
