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

NCT ID: NCT04402853

Last Updated: 2020-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2020-05-20

Brief Summary

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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

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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

Conditions

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Sars-CoV2 Tear

Keywords

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COVID 19 EYE Tears

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID 19 Patients

hospitalized patients with COVID 19

Tears swab

Intervention Type DIAGNOSTIC_TEST

rtPCR on tears swabs samples

Interventions

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Tears swab

rtPCR on tears swabs samples

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Hospitalized COVID 19 patients

Exclusion Criteria

* Patients with respiratory support that interferes with tears sampling
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Università degli Studi dell'Insubria

OTHER

Sponsor Role lead

Responsible Party

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Simone Donati

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simone Donati, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Insubria, Varese

Locations

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ASST Sette Laghi

Varese, , Italy

Site Status

Countries

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Italy

References

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Wu P, Duan F, Luo C, Liu Q, Qu X, Liang L, Wu K. Characteristics of Ocular Findings of Patients With Coronavirus Disease 2019 (COVID-19) in Hubei Province, China. JAMA Ophthalmol. 2020 May 1;138(5):575-578. doi: 10.1001/jamaophthalmol.2020.1291.

Reference Type BACKGROUND
PMID: 32232433 (View on PubMed)

Hong N, Yu W, Xia J, Shen Y, Yap M, Han W. Evaluation of ocular symptoms and tropism of SARS-CoV-2 in patients confirmed with COVID-19. Acta Ophthalmol. 2020 Aug;98(5):e649-e655. doi: 10.1111/aos.14445. Epub 2020 Apr 26.

Reference Type RESULT
PMID: 32336042 (View on PubMed)

Related Links

Other Identifiers

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72/2020

Identifier Type: -

Identifier Source: org_study_id