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Clinical Trials/NCT04402853
NCT04402853CompletedNot Applicable

SARS Cov-2 in Conjunctival Secretions in an Italian Lombardia Cohort of Patients

Università degli Studi dell'Insubria1 site in 1 country100 target enrollmentStarted: February 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Virus presence in COVID 19 patients tears

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Crossover
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Hospitalized COVID 19 patients

Exclusion Criteria

  • Patients with respiratory support that interferes with tears sampling

Outcomes

Primary Outcomes

Virus presence in COVID 19 patients tears

Time Frame: 1 day

prevalence of SARS CoV 2 virus on tears

Secondary Outcomes

  • Concordance to Naso-Pharingeal Swab(1 day)

Investigators

Sponsor
Università degli Studi dell'Insubria
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Simone Donati

Associate Professor

Università degli Studi dell'Insubria

Study Sites (1)

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