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

NCT04654325 | Terminated

• 2 other identifiers: APHP2012682020-A02996-33
• Study Type: interventional
• Target: 534
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

SARS-CoV-2

Keywords

SARS-CoV-2; COVID19; conjunctiva; tears

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• assessement of viral load levels

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

Study Arms (1)

Patients attending to the COVID19 screening facility

OTHER

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

Interventions

conjunctival swab DIAGNOSTIC_TEST

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

Patients attending to the COVID19 screening facility

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

MeSH Terms

Conditions

COVID-19; Lacerations

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Wounds and Injuries

Study Officials

• Antoine Rousseau, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 4, 2020
• Study Start: January 19, 2021
• Primary Completion: April 29, 2021
• Study Completion: April 29, 2021
• Last Updated: September 9, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)