SARS Cov-2 in Conjunctival Secretion in COVID-19 Patients

Completed

• Conditions: Sars-CoV2; Tear
• Interventions: Diagnostic Test: Tears swab

• Registration Number: NCT04402853
• Lead Sponsor: Università degli Studi dell'Insubria

Brief Summary

Observational study to evaluate the presence of SARS COV-2 in tears collected in COVID-19 patients in Lombardia region, northern Italy, and to correlate virus presence to concomitant systemic clinical conditions.

Detailed Description

Since February 2020, Coronavirurus Disease 2019 associated to a severe acute respiratory syndrome started in China and rapidly spread all over the world and in particular in northern Italy. There are many reasons to justify this rapid diffusion in Italian Lombardia region as the high population density with more possibilities of interpersonal contact, high prevalence of respiratory pathologies, in particular in elderly people, due to pollution, high number of contacts with Chinese population for travelling and business reasons, and at last the non-windy temperate climate conditions, that increases the persistence of virus in the environment.

At now, more than eighty thousand citizens from Lombardia Region have been officially affected by the disease with a high death toll, also considering that actual numbers are certainly much underestimated.

The aim of the present study was to evaluate the prevalence of SARS COV-2 virus in tears collected from COVID-19 patients by rtPCR analysis directed to target sites of viral RNA, and to correlate virus presence to concomitant systemic clinical conditions

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-05-20
• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-22
• Study First Posted: 2020-05-27
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-01
• Last Update Posted: 2020-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Hospitalized COVID 19 patients

Exclusion Criteria

• Patients with respiratory support that interferes with tears sampling

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID 19 Patients	Tears swab	hospitalized patients with COVID 19

Primary Outcome Measures

Name	Time	Method
Virus presence in COVID 19 patients tears	1 day	prevalence of SARS CoV 2 virus on tears

Secondary Outcome Measures

Name	Time	Method
Concordance to Naso-Pharingeal Swab	1 day	Evaluation of concordance with Naso-Pharingeal testing

Trial Locations

Locations (1)

ASST Sette Laghi; 🇮🇹 Varese, Italy