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

September 6, 2022 updated by: Assistance Publique - Hôpitaux de Paris
To evaluate the prevalence of SARS-CoV-2 genome in patients with asymptomatic and moderately symptomatic COVID19.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

534

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Kremlin Bicetre, France, 94270
        • Hôpital Bicêtre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients attending to the COVID19 screening facility
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
Diagnostic test: conjunctival swab
Patients will have conjunctival swab for SARS-CV-2 genome detection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence of SARS-CoV-2 genome in tears
Time Frame: at the end of the study, an average of 1 year
Prevalence of SARS-CoV-2 genome in tears
at the end of the study, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence of systemic symptoms evaluated at the time of making an appointment by a systematic standardized interrogation
Time Frame: 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
at the end of the study, an average of 1 year
assessement of viral load levels
Time Frame: 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)
at the end of the study, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Antoine Rousseau, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2021

Primary Completion (Actual)

April 29, 2021

Study Completion (Actual)

April 29, 2021

Study Registration Dates

First Submitted

November 30, 2020

First Submitted That Met QC Criteria

December 3, 2020

First Posted (Actual)

December 4, 2020

Study Record Updates

Last Update Posted (Actual)

September 9, 2022

Last Update Submitted That Met QC Criteria

September 6, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP201268
  • 2020-A02996-33 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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