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Glasses Against Transmission of SARS-CoV-2 (COVID-19) in the Community (GLASSY)

2022年4月19日 更新者:Norwegian Institute of Public Health

The GLasses Against Transmission of SARS-CoV-2 (COVID-19) in the communitY (GLASSY) Trial: A Pragmatic Randomized Trial

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.

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

介入性

注册 (预期的)

25000

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

      • Oslo、挪威、0213
        • 招聘中
        • Norwegian Institute of Public Health
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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.).
Participants are asked to wear glasses in public spaces.
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.).

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
Positive test for SARS-CoV-2
大体时间:Days 3 to 17 after start of trial period.
We will compare the incidence of notified cases of COVID-19 (i.e. registered positive SARS-CoV-2 tests).
Days 3 to 17 after start of trial period.

次要结果测量

结果测量
措施说明
大体时间
Health care use for respiratory symptoms
大体时间:Day 1 to 28
Routinely collected data (Norwegian Registry for Primary Health Care (KPR) and Norwegian Patient Registry (NPR) databases)
Day 1 to 28
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
Routinely collected data (KPR and NPR databases)
Day 1 to 21
Health care use (all causes)
大体时间:Day 1 to 21
Routinely collected data (KPR and NPR databases)
Day 1 to 21
Any positive COVID-19 test result
大体时间:Day 1 to 17
Self report
Day 1 to 17
Respiratory symptoms
大体时间:Day 1 to 17
Self report
Day 1 to 17
Health care use for respiratory symptoms
大体时间:Day 1 to 17
Self report
Day 1 to 17
Health care use for injuries
大体时间:Day 1 to 17
Self report
Day 1 to 17
Health care use (all causes)
大体时间:Day 1 to 17
Self report
Day 1 to 17

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年2月2日

初级完成 (预期的)

2022年5月1日

研究完成 (预期的)

2023年6月1日

研究注册日期

首次提交

2022年1月31日

首先提交符合 QC 标准的

2022年1月31日

首次发布 (实际的)

2022年2月1日

研究记录更新

最后更新发布 (实际的)

2022年4月20日

上次提交的符合 QC 标准的更新

2022年4月19日

最后验证

2022年2月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

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

The investigators expect to be able to share unidentifiable dataset with partners inside the European Union (EU) by May 2022, and an anonymous dataset for wide distribution at a later stage.

IPD 共享访问标准

Data that are not fully anonymized will only be shared within the EU (due to data protection regulations).

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

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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