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COVID-19 Search in Conjunctival Cells (COVID-T)

I

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Completed

Conditions

Pulmonary Disease
COVID 19

Treatments

Diagnostic Test: conjunctival swab

Study type

Interventional

Funder types

Other

Identifiers

NCT04364594
0013008/20

Details and patient eligibility

About

The patients enrolled in this study will be all patients entering triage with suspicion of SARS-CoV2. Planned activities are required by the nasopharyngeal swab in parallel with the analysis of the conjunctival swab to identify new potential alternative and equally effective diagnostic pathways.

Simultaneously systemic data (as Pulmonary images, hematological parameters etc.) will be collected to observe a possible correlation between conjunctival swab positivity and systemic impairment.

Full description

In recent months, considerable interest has turned to Coronavirus infection in terms of early diagnosis and targeted therapy. Thanks to the experimentation of new therapeutic strategies, it becomes more and more evident how some subgroups of patients can benefit from a specific treatment, while others would have no benefit.

Alongside these innovative clinical research techniques, early diagnosis that would lead to identifying those at risk of a new disease and new infection is becoming increasingly important.

COVID-19 occurred in China in December 2019 but probably already had an expression in the previous months. The number of victims reached its peak in January 2020 with prevalent involvement of patients already at risk or with previous physical debilitations. But even apparently healthy and young individuals can be affected by infections with a lethal outcome. Since January 2020 new cases have been registered all over the world and prevalently in Italy. The main way of infection identified is the respiratory tract, but infection through conjunctival may not be excluded.

The main outcome of this research is to investigate the positivity of the COVID-19 virus in the conjunctival mucosa to establish a new diagnostic target.

All patients will receive both the conjunctival swab and nasopharyngeal swab. The conjunctival swab will be performed in each eye and both swabs will be inserted into the same virus test tube. The swab samples will be sent in the same day to the microbiology laboratory for examination by Real Time-PCR.

The secondary outcome will be to evaluate the possible positivity of the conjunctival swab with the degree of systemic impairment. This objective has the purpose of personalized medicine.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients accepted to triage with positivity or suspected positivity to COVID-19 will be enrolled in the study and both conjunctival and nasopharyngeal swab will be performed.

Exclusion criteria

  • To date, there are no exclusion criteria

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

affected individual
Experimental group
Description:
Patients affected by Coronavirus 19 admitted to the hospital setting
Treatment:
Diagnostic Test: conjunctival swab

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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