- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05217797
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Atle Fretheim, PhD
- Telefonnummer: +4791649828
- E-post: atle.fretheim@fhi.no
Studer Kontakt Backup
- Navn: Arnfinn Helleve, PhD
- E-post: arnfinn.helleve@fhi.no
Studiesteder
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Oslo, Norge, 0213
- Rekruttering
- Norwegian Institute of Public Health
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Ta kontakt med:
- Atle Fretheim, PhD MD
- E-post: atle.fretheim@fhi.no
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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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Ingen inngripen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Positive test for SARS-CoV-2
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Health care use for respiratory symptoms
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Day 1 to 17
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Self report
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Day 1 to 17
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Respiratory symptoms
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: Day 1 to 17
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Self report
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Day 1 to 17
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Atle Fretheim, PhD, Head of Centre for Epidemic Interventions Research (CEIR)
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P360-22/00592
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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