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NCT Number: NCT04402853

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

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.

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Key information

Conditions

Sars-CoV2 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lacerations Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Tear Virus Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ASST Sette Laghi

Varese, 21100, Italy

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hospitalized COVID 19 patients

Exclusion criteria

  • Patients with respiratory support that interferes with tears sampling

Treatment and study plan

Tears swab

Diagnostic Test

rtPCR on tears swabs samples

Primary outcomes

  1. Virus presence in COVID 19 patients tears

    Time frame: 1 day

    prevalence of SARS CoV 2 virus on tears

Secondary outcomes

  1. Concordance to Naso-Pharingeal Swab

    Time frame: 1 day

    Evaluation of concordance with Naso-Pharingeal testing

Sponsors and collaborators

Lead sponsor

Università degli Studi dell'Insubria

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 27, 2020
Registry last updated
Dec 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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