Covid19Eye-CovidNCT04799704

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

An observational study of Covid19 and Eye Diseases, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

To investigate the presence of SARS-nCoV-2 in the tear film of symptomatic and pauci-symptomatic SARS-nCoV-2 positive patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Covid19, Eye Diseases
What is being tested?: swabbing of conjunctiva
How many people: 30 participants
Where: 1 siteBelgium
Study dates: 11 Sep 2020to 13 Dec 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

Allergy to Oxybuprocainehydrochloride
Pregnancy or lactation

Trial locations and contacts

1 site in 1 country.

Belgium1 site

UZ Leuven
Leuven, Vlaams Brabant, 3000

Other trials in Belgium

About this study

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

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

Read the 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.

Conditions: Covid19, Eye Diseases
Being tested: swabbing of conjunctiva
Medical subject headings: COVID-19, Eye Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

swabbing of conjunctivaDiagnostic test
Each eye will be sampled with a single, sterile, nylon, flocked swab

Study groups in NCT04799704
Study group	Role	What they receive
symptomatic patient		to confirm the detectability of the SARS-nCoV-2 in the tear film of symptomatic patients. Receives: Diagnostic Test: swabbing of conjunctiva

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Sep 202013 Dec 2020

First posted16 Mar 2021
Study start11 Sep 2020
Primary completion13 Dec 2020
Study completion13 Dec 2020

Why it stopped: insufficient positive samples

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Covid19Studies of the same condition, open and under way.
More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04799704
Sponsor's protocol ID: S64002
Acronym: Eye-Covid
Status last verified: Jun 2022
First submitted: 11 Mar 2021
Last updated: 24 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 35367365

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tear Film SARS-nCoV-2 Detection in Symptomatic and Pauci-symptomatic
ClinicalTrials.gov ID: NCT04799704
Acronym / sponsor ID: Eye-Covid / S64002
Conditions: Covid19, Eye Diseases
Study type: Observational
Recruitment status: TerminatedReason stopped: insufficient positive samples
Enrolment: 30 participants (actual)
Lead sponsor: Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
Study start: 11 Sep 2020 (actual)
Primary completion: 13 Dec 2020 (actual)
Study completion: 13 Dec 2020 (actual)
First posted: 16 Mar 2021 (actual)
Results: Posted 24 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
symptomatic patient	–	Diagnostic Test: swabbing of conjunctivato confirm the detectability of the SARS-nCoV-2 in the tear film of symptomatic patients.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: positive test for SARS-nCoV-2 on a nasopharyngeal swab.

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (2 listed)

Allergy to Oxybuprocainehydrochloride
Pregnancy or lactation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
swabbing of conjunctivaEach eye will be sampled with a single, sterile, nylon, flocked swab	Diagnostic test	symptomatic patient

Primary outcome

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

Results and safety

Results posted to the registry on 24 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Symptomatic Patient	30	30

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

Time frame: during hospitalization every 3 days until the day of discharge up to 1 month. Number. Unit: swabs

Measure	Symptomatic Patient n = 30
positive SARS-CoV-2 swab	13
strongly positive SARS-CoV-2	3
weakly positive SARS-CoV-2	10

Population analysed: symptomatic patients admitted at our University Hospital Leuven, Belgium with a positive nasopharyngeal swab for SARS-nCoV-2

Adverse events

Time frame: Sampling will be repeated every 3 days to evaluate if PCR becomes positive during the course of disease and to monitor the duration of detectability of the virus in tears, up to 1 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Symptomatic Patient	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 35367365Leysen 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.
In search of viable SARS-CoV-2 in the tear film: a prospective clinical study in hospitalized symptomatic patients.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Delbeke Heleen, MD principal investigator

UZ Leuven

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19 and Eye Diseases, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Presence of SARS-nCoV-2 in the Tear Film of Symptomatic and Pauci-symptomatic SARS-nCoV-2 Positive Patients. (time frame: during hospitalization every 3 days until the day of discharge up to 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04799704, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.