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

NCT04799704 | Terminated Results

• 1 other identifier: S64002
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Covid19; Eye Diseases

Outcome Measures

Primary Outcomes (1)

• The Presence of SARS-nCoV-2 in the Tear Film of Symptomatic and Pauci-symptomatic SARS-nCoV-2 Positive Patients.

  Bilateral conjunctival sampling will be performed on both eyes after the application of a drop of topical anesthesia at least once.

  during hospitalization every 3 days until the day of discharge up to 1 month

Study Arms (1)

symptomatic patient

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

Diagnostic Test: swabbing of conjunctiva

Interventions

swabbing of conjunctiva DIAGNOSTIC_TEST

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

symptomatic patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

positive test for SARS-nCoV-2 on a nasopharyngeal swab.

You may qualify if:

• 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.

You may not qualify if:

• Allergy to Oxybuprocainehydrochloride
• Pregnancy or lactation

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 35367365 RESULT

Related Links

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

MeSH Terms

Conditions

COVID-19; Eye Diseases

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Heleen Delbeke, MD
• Organization: UZ Leuven

heleen.delbeke@uzleuven.be

003216342229

Study Officials

• Delbeke Heleen, MD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 16, 2021
• Study Start: September 11, 2020
• Primary Completion: December 13, 2020
• Study Completion: December 13, 2020
• Last Updated: January 24, 2025
• Results First Posted: January 24, 2025

Record last verified: 2022-06

Locations

BE (1)