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

Primary Purpose

SARS-CoV-2

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

conjunctival swab

About this trial

This is an interventional other trial for SARS-CoV-2 focused on measuring SARS-CoV-2, COVID19, conjunctiva, tears

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hôpital Bicêtre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients attending to the COVID19 screening facility

Arm Description

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

Outcomes

Primary Outcome Measures

presence of SARS-CoV-2 genome in tears

Prevalence of SARS-CoV-2 genome in tears

Secondary Outcome Measures

presence of systemic symptoms evaluated at the time of making an appointment by a systematic standardized interrogation

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

correlation between nasopharyngeal viral load and conjunctival load (indirectly assessed with cycle thresholds quantification method)

Full Information

NCT ID

NCT04654325

First Posted

November 30, 2020

Last Updated

September 6, 2022

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT04654325

Brief Title

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

Acronym

COVIDEYE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Terminated

Why Stopped

less covid testing

Study Start Date

January 19, 2021 (Actual)

Primary Completion Date

April 29, 2021 (Actual)

Study Completion Date

April 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SARS-CoV-2

Keywords

SARS-CoV-2, COVID19, conjunctiva, tears

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

534 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients attending to the COVID19 screening facility

Arm Type

Other

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

conjunctival swab

Intervention Description

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

Primary Outcome Measure Information:

Title

presence of SARS-CoV-2 genome in tears

Description

Prevalence of SARS-CoV-2 genome in tears

Time Frame

at the end of the study, an average of 1 year

Secondary Outcome Measure Information:

Title

presence of systemic symptoms evaluated at the time of making an appointment by a systematic standardized interrogation

Description

Time Frame

at the end of the study, an average of 1 year

Title

assessement of viral load levels

Description

correlation between nasopharyngeal viral load and conjunctival load (indirectly assessed with cycle thresholds quantification method)

Time Frame

at the end of the study, an average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Antoine Rousseau, PhD

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Bicêtre

City

Le Kremlin Bicetre

ZIP/Postal Code

94270

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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