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Prevalence of SARS-CoV-2 Genome in Tears of Asymptomatic and Moderately Symptomatic COVID-19 Patients

Prevalence of SARS-CoV-2 Genome in Tears of Asymptomatic and Moderately Symptomatic COVID-19 Patients

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04654325
Acronym
COVIDEYE
Enrollment
534
Registered
2020-12-04
Start date
2021-01-19
Completion date
2021-04-29
Last updated
2022-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV-2

Keywords

SARS-CoV-2, COVID19, conjunctiva, tears

Brief summary

To evaluate the prevalence of SARS-CoV-2 genome in patients with asymptomatic and moderately symptomatic COVID19.

Detailed description

Patients attending to the COVID19 screening facility of Paris South University hospital and willing to participate to the study will have both nasopharyngeal and conjunctival swab for SARS-CV-2 genome detection using PCR. The project will evaluate the prevalence of positive conjunctival swabs in patients with positive nasopharyngeal swab. These results will be corelated to symptoms of disease assessed with a standardized questionnaire.

Interventions

DIAGNOSTIC_TESTconjunctival swab

Patients will have conjunctival swab for SARS-CV-2 genome detection

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients receiving diagnostic nasopharyngeal PCR for COVID-19 as part of the usual care * Age ≥ 18. * Information and signature of consent * Affiliated with a social security scheme or entitled

Exclusion criteria

* Refusal to participate in the study * Eye surgery less than 3 months old * Unable to give informed consent * No coverage through the health insurance system * Patient under judicial protection * Patient on AME

Design outcomes

Primary

MeasureTime frameDescription
presence of SARS-CoV-2 genome in tearsat the end of the study, an average of 1 yearPrevalence of SARS-CoV-2 genome in tears

Secondary

MeasureTime frameDescription
presence of systemic symptoms evaluated at the time of making an appointment by a systematic standardized interrogationat the end of the study, an average of 1 yearcorrelation between systemic symptoms (fever, chills, sweating, muscle aches, headache, runny or stuffy nose, cough, sore throat, asthenia, anosmia, agueusia, unusual shortness of breath, skin rash diarrhea, nausea vomiting) and positive conjunctival swab
assessement of viral load levelsat the end of the study, an average of 1 yearcorrelation between nasopharyngeal viral load and conjunctival load (indirectly assessed with cycle thresholds quantification method)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026