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

SARS-CoV-2 Clinical Trial

— COVIDEYE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04654325
• Other study ID #: APHP201268
• Secondary ID: 2020-A02996-33
• Status: Terminated
• Phase: N/A
• Start date: January 19, 2021
• Est. completion date: April 29, 2021

Study information

• Verified date: September 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 534
• Est. completion date: April 29, 2021
• Est. primary completion date: April 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

Intervention

Diagnostic Test:
• conjunctival swab
Patients will have conjunctival swab for SARS-CV-2 genome detection

Locations

Country	Name	City	State
France	Hôpital Bicêtre	Le Kremlin Bicetre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of SARS-CoV-2 genome in tears	Prevalence of SARS-CoV-2 genome in tears	at the end of the study, an average of 1 year
Secondary	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	at the end of the study, an average of 1 year
Secondary	assessement of viral load levels	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