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

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Completed

CT.gov ID

NCT04799704

Collaborator

(none)

Enrollment

Location

3.1

Actual Duration (Months)

9.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Covid19 Eye Diseases	Diagnostic Test: swabbing of conjunctiva

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 Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 11, 2020

Actual Primary Completion Date :

Dec 13, 2020

Actual Study Completion Date :

Dec 13, 2020

Arms and Interventions

Arm	Intervention/Treatment
symptomatic patient The first part of our study is to confirm the detectability of the SARS-nCoV-2 in the tear film of symptomatic patients.	Diagnostic Test: swabbing of conjunctiva Each eye will be sampled with a single, sterile, nylon, flocked swab

Arm

Intervention/Treatment

symptomatic patient

The first part of our study is to confirm the detectability of the SARS-nCoV-2 in the tear film of symptomatic patients.

Diagnostic Test: swabbing of conjunctiva

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

Outcome Measures

Primary Outcome Measures

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]
Conjunctival sampling will be performed on both eyes after the application of a drop of topical anesthesia
Correlations between SARS-nCoV-2 in the tear film [during hospitalization every 3 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Leuven	Leuven	Vlaams Brabant	Belgium	3000

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Investigators

Principal Investigator: Delbeke Heleen, MD, UZ Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitaire Ziekenhuizen Leuven

ClinicalTrials.gov Identifier:

NCT04799704

Other Study ID Numbers:

S64002

First Posted:

Mar 16, 2021

Last Update Posted:

Mar 16, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Eye Diseases

Study Results

No Results Posted as of Mar 16, 2021