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

Covid19 Clinical Trial

— Eye-Covid  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04799704
• Other study ID #: S64002
• Status: Completed
• Start date: September 11, 2020
• Est. completion date: December 13, 2020

Study information

• Verified date: March 2021
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 13, 2020
• Est. primary completion date: December 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Eye Diseases

Intervention

Diagnostic Test:
• swabbing of conjunctiva
Each eye will be sampled with a single, sterile, nylon, flocked swab

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The presence of SARS-nCoV-2 in the tear film of symptomatic and pauci-symptomatic SARS-nCoV-2 positive patients.	Conjunctival sampling will be performed on both eyes after the application of a drop of topical anesthesia	during hospitalization every 3 days
Primary	Correlations between SARS-nCoV-2 in the tear film	Correlations between SARS-nCoV-2 in the tear film and mild (like anosmia, ageusia, upper and lower respiratory tract infection) or severe symptoms (as pneumonia, need for hospitalization) of COVID-19.	during hospitalization every 3 days