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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04654325

Collaborator

(none)

1,280

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2	Diagnostic Test: conjunctival swab	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1280 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT04654325

Other Study ID Numbers:

APHP201268
2020-A02996-33

First Posted:

Dec 4, 2020

Last Update Posted:

Dec 4, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Assistance Publique - Hôpitaux de Paris

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Dec 4, 2020