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

December 1, 2020 updated by: Simone Donati, Università degli Studi dell'Insubria

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Varese, Italy, 21100
        • ASST Sette Laghi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Hospitalized patients with a confirmed diagnosis of COVID 19 pneumonia

Description

Inclusion Criteria:

  • Hospitalized COVID 19 patients

Exclusion Criteria:

  • Patients with respiratory support that interferes with tears sampling

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID 19 Patients
hospitalized patients with COVID 19
Diagnostic test: Tears swab
rtPCR on tears swabs samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Virus presence in COVID 19 patients tears
Time Frame: 1 day
prevalence of SARS CoV 2 virus on tears
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance to Naso-Pharingeal Swab
Time Frame: 1 day
Evaluation of concordance with Naso-Pharingeal testing
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi dell'Insubria

Investigators

  • Principal Investigator: Simone Donati, Professor, University of Insubria, Varese

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

May 20, 2020

Study Registration Dates

First Submitted

May 22, 2020

First Submitted That Met QC Criteria

May 22, 2020

First Posted (Actual)

May 27, 2020

Study Record Updates

Last Update Posted (Actual)

December 3, 2020

Last Update Submitted That Met QC Criteria

December 1, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 72/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The study will be published

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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