Official Title
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2): Diagnostic Targets for Customized Medicine.
Brief Summary

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.

Detailed 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.

Completed
COVID 19
Pulmonary Disease

Diagnostic Test: conjunctival swab

analysis of conjunctival cells (real time PCR) collected by conjunctival swabs in both eyes
Other Name: Pulmonary involvement determined by X-Ray (XR) rays and Computed Tomography (CT) scan

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Italy
Locations

Maria Cristina Savastano
Roma, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NCT Number
Keywords
Conjunctival swabs
diagnosis
SARS-CoV2
Systemic Impairment
MeSH Terms
COVID-19