Tear Film SARS-nCoV-2 Detection in Symptomatic and Pauci-symptomatic Patients.

NCT ID: NCT04799704

Last Updated: 2025-01-24

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-11

Study Completion Date

2020-12-13

Brief Summary

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To investigate the presence of SARS-nCoV-2 in the tear film of symptomatic and pauci-symptomatic SARS-nCoV-2 positive patients.

Detailed Description

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The end goal of the study is to show whether or not the virus can be found in the tear film in both symptomatic and less symptomatic patients by means of serial sampling.

A sample of the tears / conjunctiva will be taken with a soft brush (similar to a cotton swab) every three days until the end of the hospitalization. In addition, you must complete a questionnaire that assesses the symptoms present.

Conditions

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Covid19 Eye Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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symptomatic patient

to confirm the detectability of the SARS-nCoV-2 in the tear film of symptomatic patients.

swabbing of conjunctiva

Intervention Type DIAGNOSTIC_TEST

Each eye will be sampled with a single, sterile, nylon, flocked swab

Interventions

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swabbing of conjunctiva

Each eye will be sampled with a single, sterile, nylon, flocked swab

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Subject needs to be above 18 years old.
* The subject is willing to undergo sampling of the conjunctiva.
* The subject is willing to fill in a questionnaire.
* The subject is fluent in written and verbal Dutch.
* The subject is capable of giving informed consent.
* Applicable for part 1 only: the subject test positive for SARS-nCoV-2 on a nasopharyngeal swab. The time window between a positive nasopharyngeal swab and the first conjunctival swab may be no more than 3 days.

Exclusion Criteria

* Allergy to Oxybuprocainehydrochloride
* Pregnancy or lactation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Delbeke Heleen, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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UZ Leuven

Leuven, Vlaams Brabant, Belgium

Site Status

Countries

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Belgium

References

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Leysen L, Delbeke H, Desmet S, Schauwvlieghe PP, Maes P, Blanckaert G, Matthys E, Joossens M, Casteels I. In search of viable SARS-CoV-2 in the tear film: a prospective clinical study in hospitalized symptomatic patients. Clin Microbiol Infect. 2022 Aug;28(8):1172-1173. doi: 10.1016/j.cmi.2022.03.026. Epub 2022 Mar 31. No abstract available.

Reference Type RESULT
PMID: 35367365 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://doi.org/10.1016/j.cmi.2022.03.026

In search of viable SARS-CoV-2 in the tear film: a prospective clinical study in hospitalized symptomatic patients.

Other Identifiers

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S64002

Identifier Type: -

Identifier Source: org_study_id

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