The GLasses Against Transmission of SARS-CoV-2 (COVID-19) in the communitY (GLASSY) Trial: A Pragmatic Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,717
- 试验地点
- 1
- 主要终点
- Positive test for SARS-CoV-2
研究概览
简要总结
In this trial the researchers plan to recruit 25,000 volunteers to be randomly allocated either wearing sunglasses or ordinary glasses in public spaces where they are close to other people, or not wear glasses in such circumstances. For each participant the trial period is 2 weeks, after which they will be asked to complete a brief questionnaire which includes questions about results of COVID-19 tests during the trial period.
详细描述
A systematic review of observational studies indicated that eye protection may be an effective measure to prevent SARS-CoV-2 infections. Randomized trials are needed to assess whether the observed associations are caused by protection of the eye or confounding factors such as other systematic differences between users and non-users of eye protection, co-interventions, or changes in COVID-19 incidence when comparisons were done over time.
This is a pragmatic, virtual, parallel group, 1:1 randomized, superiority trial. The researchers will recruit and randomize participants via an online portal. The trial will be fully remote and virtual without any personal interaction between investigators and participants. All members of the public are eligible who confirm that they are at least 18 years of age, do not regularly wear glasses, have not contracted COVID-19 since December 15th 2021, and are willing to be randomized to wear, or not wear glasses in public when close to other people, for a 2-week period. Persons who are dependent on visual aids but typically use contact lenses are eligible. The participants will be randomized (1:1) to wear glasses (sunglasses or other types of glasses) in public spaces when close to others (public transport, shopping centers etc.), or to the control group. The control group will be asked not to wear glasses in public spaces when close to others. The primary outcome is positive test for COVID-19.
The researchers aim to include about 25,000 participants to have a statistical power of 80% to detect a relative risk reduction of 25% for the primary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
No blinding was feasible, except for in the analysis phase. One member of our team (A.H.) provided the chief analyst (I.H.E.) with a data file in which group allocation was blinded. The chief analyst presented the main results to the project team members, who were also blinded to the group allocation (and data on use of glasses). We discussed how we would interpret the findings depending on whether one group or the other was the intervention group, and we prepared a short report that we posted online before unblinding ourselves to the group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least 18 years of age
- •owns or can borrow glasses that can be used (e.g. sun-glasses)
- •willing to be randomized to wear, or not wear glasses outside the home when close to others, for a 2-week period.
- •provides informed consent
排除标准
- •does regularly wear glasses (contact lenses are accepted)
- •contracted COVID-19 after December 15th 2021.
研究组 & 干预措施
Glasses
Participants in the experimental arm are asked to wear glasses (sunglasses or other glasses) when outside their home and close to others (e.g. on public transport, in shopping centres etc.).
干预措施: Wearing glasses (any type) (Behavioral)
Not glasses
Participants in no interventions arm are asked to not wear glasses (sunglasses or other glasses) when outside their home and close to others (e.g. on public transport, in shopping centres etc.).
结局指标
主要结局
Positive test for SARS-CoV-2
时间窗: Days 3 to 17 after start of trial period.
The investigators will compare the incidence of notified cases of COVID-19 (i.e. registered positive SARS-CoV-2 tests).
次要结局
- Any positive COVID-19 test result(Day 1 to 17)
- Respiratory symptoms(Day 1 to 17)
- Health care use for respiratory symptoms(Day 1 to 17)
- Health care use for injuries health care use (all causes) from day 1 to day 21 (data source: KPR and NPR(Day 1 to 21)
- Health care use (all causes)(Day 1 to 17)
- Health care use for injuries(Day 1 to 17)
- Health care use for respiratory symptoms(Day 1 to 28)
- Health care use (all causes)(Day 1 to 21)