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

19. april 2022 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

25000

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Norge
      • Oslo, Norge, 0213
        • Rekruttering
        • Norwegian Institute of Public Health
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.).
Adfærdsmæssigt: Wearing glasses (any type)
Participants are asked to wear glasses in public spaces.
Ingen indgriben: 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.).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Positive test for SARS-CoV-2
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Health care use for respiratory symptoms
Tidsramme: 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
Tidsramme: Day 1 to 21
Routinely collected data (KPR and NPR databases)
Day 1 to 21
Health care use (all causes)
Tidsramme: Day 1 to 21
Routinely collected data (KPR and NPR databases)
Day 1 to 21
Any positive COVID-19 test result
Tidsramme: Day 1 to 17
Self report
Day 1 to 17
Respiratory symptoms
Tidsramme: Day 1 to 17
Self report
Day 1 to 17
Health care use for respiratory symptoms
Tidsramme: Day 1 to 17
Self report
Day 1 to 17
Health care use for injuries
Tidsramme: Day 1 to 17
Self report
Day 1 to 17
Health care use (all causes)
Tidsramme: Day 1 to 17
Self report
Day 1 to 17

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Norwegian Institute of Public Health

Samarbejdspartnere

University of Basel

Efterforskere

  • Ledende efterforsker: Atle Fretheim, PhD, Head of Centre for Epidemic Interventions Research (CEIR)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. februar 2021

Primær færdiggørelse (Forventet)

1. maj 2022

Studieafslutning (Forventet)

1. juni 2023

Datoer for studieregistrering

Først indsendt

31. januar 2022

Først indsendt, der opfyldte QC-kriterier

31. januar 2022

Først opslået (Faktiske)

1. februar 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. april 2022

Sidst verificeret

1. februar 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P360-22/00592

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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