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

NCT05217797 | Completed

• 1 other identifier: P360-22/00592
• Study Type: interventional
• Target: 3,717
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; Respiratory Tract Infections

Keywords

COVID-19 Prevention Protection

Outcome Measures

Primary Outcomes (1)

• Positive test for SARS-CoV-2

  The investigators 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.

Secondary Outcomes (8)

• Health care use for respiratory symptoms

  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

  Day 1 to 21

• Health care use (all causes)

  Day 1 to 21

• Any positive COVID-19 test result

  Day 1 to 17

• Respiratory symptoms

  Day 1 to 17

Study Arms (2)

Glasses

EXPERIMENTAL

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.).

Behavioral: Wearing glasses (any type)

Not glasses

NO INTERVENTION

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.).

Interventions

Wearing glasses (any type) BEHAVIORAL

Participants are asked to wear glasses in public spaces.

Glasses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• does regularly wear glasses (contact lenses are accepted)
• contracted COVID-19 after December 15th 2021.

Sponsors & Collaborators

• Norwegian Institute of Public Health: lead
• University of Basel: collaborator

Study Sites (1)

Norwegian Institute of Public Health

Oslo, 0213, Norway

Location

Related Publications (1)

• Fretheim A, Elgersma IH, Helleve A, Elstrom P, Kacelnik O, Hemkens LG. Effect of Wearing Glasses on Risk of Infection With SARS-CoV-2 in the Community: A Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2244495. doi: 10.1001/jamanetworkopen.2022.44495.

  PMID: 36454571 RESULT

MeSH Terms

Conditions

COVID-19; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Atle Fretheim, PhD

  Head of Centre for Epidemic Interventions Research (CEIR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No blinding was feasible, except for in the analysis phase. One member of our team (A.H.) provided the chief analyst (I.H.E.) with a data file in which group allocation was blinded. The chief analyst presented the main results to the project team members, who were also blinded to the group allocation (and data on use of glasses). We discussed how we would interpret the findings depending on whether one group or the other was the intervention group, and we prepared a short report that we posted online before unblinding ourselves to the group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Sequence generation We will use a simple 1:1 randomization by means of computer-generated random numbers. The allocation will be concealed as the participant themselves will be directly informed of their allocation as soon as they have agreed to take part in the trial and have completed the online consent form. Generation of allocation sequence, enrolment of participants and assignment of participants will all be handled by the digital recruitment platform.

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 1, 2022
• Study Start: February 2, 2021
• Primary Completion: May 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: Data that are not fully anonymized will only be shared within the EU (due to data protection regulations).

Locations

NO (1)