Glasses Against Transmission of SARS-CoV-2 (COVID-19) in the Community (GLASSY)
The GLasses Against Transmission of SARS-CoV-2 (COVID-19) in the communitY (GLASSY) Trial: A Pragmatic Randomized Trial
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Atle Fretheim, PhD
- 电话号码:+4791649828
- 邮箱:atle.fretheim@fhi.no
研究联系人备份
- 姓名:Arnfinn Helleve, PhD
- 邮箱:arnfinn.helleve@fhi.no
学习地点
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Oslo、挪威、0213
- 招聘中
- Norwegian Institute of Public Health
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接触:
- Atle Fretheim, PhD MD
- 邮箱:atle.fretheim@fhi.no
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- does regularly wear glasses (contact lenses are accepted)
- contracted COVID-19 after December 15th 2021.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的: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.).
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Participants are asked to wear glasses in public spaces.
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无干预: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.).
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Positive test for SARS-CoV-2
大体时间:Days 3 to 17 after start of trial period.
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We will compare the incidence of notified cases of COVID-19 (i.e.
registered positive SARS-CoV-2 tests).
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Days 3 to 17 after start of trial period.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Health care use for respiratory symptoms
大体时间:Day 1 to 28
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Routinely collected data (Norwegian Registry for Primary Health Care (KPR) and Norwegian Patient Registry (NPR) databases)
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Day 1 to 28
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Health care use for injuries health care use (all causes) from day 1 to day 21 (data source: KPR and NPR
大体时间:Day 1 to 21
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Routinely collected data (KPR and NPR databases)
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Day 1 to 21
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Health care use (all causes)
大体时间:Day 1 to 21
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Routinely collected data (KPR and NPR databases)
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Day 1 to 21
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Any positive COVID-19 test result
大体时间:Day 1 to 17
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Self report
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Day 1 to 17
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Respiratory symptoms
大体时间:Day 1 to 17
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Self report
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Day 1 to 17
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Health care use for respiratory symptoms
大体时间:Day 1 to 17
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Self report
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Day 1 to 17
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Health care use for injuries
大体时间:Day 1 to 17
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Self report
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Day 1 to 17
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Health care use (all causes)
大体时间:Day 1 to 17
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Self report
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Day 1 to 17
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合作者和调查者
调查人员
- 首席研究员:Atle Fretheim, PhD、Head of Centre for Epidemic Interventions Research (CEIR)
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- P360-22/00592
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
From protocol:
The researchers intend to give full access to the full protocol, participant-level dataset, and statistical code, to anyone who is interested, after securing that the dataset is fully anonymized.
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
- 分析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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