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

Not Applicable

Terminated

• Conditions: SARS-CoV-2
• Interventions: Diagnostic Test: conjunctival swab

• Registration Number: NCT04654325
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2020-11-30
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-04
• Study Start: 2021-01-19
• Primary Completion: 2021-04-29
• Study Completion: 2021-04-29
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-06
• Last Update Posted: 2022-09-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 534

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients attending to the COVID19 screening facility	conjunctival swab	Patients will have both nasopharyngeal and conjunctival swab for SARS-CV-2 genome detection using PCR. Study 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 stan

Primary Outcome Measures

Name	Time	Method
presence of SARS-CoV-2 genome in tears	at the end of the study, an average of 1 year	Prevalence of SARS-CoV-2 genome in tears

Secondary Outcome Measures

Name	Time	Method
presence of systemic symptoms evaluated at the time of making an appointment by a systematic standardized interrogation	at the end of the study, an average of 1 year	correlation 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 levels	at the end of the study, an average of 1 year	correlation between nasopharyngeal viral load and conjunctival load (indirectly assessed with cycle thresholds quantification method)

Trial Locations

Locations (1)

Hôpital Bicêtre; 🇫🇷 Le Kremlin Bicetre, France