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

Terminated

• Conditions: Covid19; Eye Diseases
• Interventions: Diagnostic Test: swabbing of conjunctiva

• Registration Number: NCT04799704
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2020-09-11
• Primary Completion: 2020-12-13
• Study Completion: 2020-12-13
• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-16
• Status Verified: 2022-06
• Results First Submitted: 2022-06-28
• Results First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Results First Posted: 2025-01-24
• Last Update Posted: 2025-01-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
symptomatic patient	swabbing of conjunctiva	The first part of our study is to confirm the detectability of the SARS-nCoV-2 in the tear film of symptomatic patients.

Primary Outcome Measures

Name	Time	Method
The Presence of SARS-nCoV-2 in the Tear Film of Symptomatic and Pauci-symptomatic SARS-nCoV-2 Positive Patients.	during hospitalization every 3 days until the day of discharge up to 1 month	Bilateral conjunctival sampling will be performed on both eyes after the application of a drop of topical anesthesia at least once.

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Vlaams Brabant, Belgium