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
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Atle Fretheim, PhD
- 電話番号:+4791649828
- メール:atle.fretheim@fhi.no
研究連絡先のバックアップ
- 名前:Arnfinn Helleve, PhD
- メール:arnfinn.helleve@fhi.no
研究場所
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Oslo、ノルウェー、0213
- 募集
- Norwegian Institute of Public Health
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コンタクト:
- Atle Fretheim, PhD MD
- メール:atle.fretheim@fhi.no
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的: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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介入なし: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Positive test for SARS-CoV-2
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Health care use for respiratory symptoms
時間枠: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
時間枠: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)
時間枠: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
時間枠:Day 1 to 17
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Self report
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Day 1 to 17
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Respiratory symptoms
時間枠: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
時間枠: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
時間枠: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)
時間枠:Day 1 to 17
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Self report
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Day 1 to 17
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協力者と研究者
捜査官
- 主任研究者:Atle Fretheim, PhD、Head of Centre for Epidemic Interventions Research (CEIR)
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- P360-22/00592
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。