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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04402853
Recruitment Status : Completed
First Posted : May 27, 2020
Last Update Posted : December 3, 2020
Information provided by (Responsible Party):
Simone Donati, 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.

Condition or disease Intervention/treatment
Sars-CoV2 Tear Diagnostic Test: Tears swab

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

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: SARS Cov-2 in Conjunctival Secretions in an Italian Lombardia Cohort of Patients
Actual Study Start Date : February 1, 2020
Actual Primary Completion Date : March 1, 2020
Actual Study Completion Date : May 20, 2020

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Virus presence in COVID 19 patients tears [ Time Frame: 1 day ]
    prevalence of SARS CoV 2 virus on tears

Secondary Outcome Measures :
  1. Concordance to Naso-Pharingeal Swab [ Time Frame: 1 day ]
    Evaluation of concordance with Naso-Pharingeal testing

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Hospitalized patients with a confirmed diagnosis of COVID 19 pneumonia

Inclusion Criteria:

  • Hospitalized COVID 19 patients

Exclusion Criteria:

  • Patients with respiratory support that interferes with tears sampling

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04402853

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ASST Sette Laghi
Varese, Italy, 21100
Sponsors and Collaborators
Università degli Studi dell'Insubria
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Principal Investigator: Simone Donati, Professor University of Insubria, Varese
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Simone Donati, Associate Professor, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT04402853    
Other Study ID Numbers: 72/2020
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The study will be published

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Simone Donati, Università degli Studi dell'Insubria: