A Study to Assess the Virus RNA, and miRNA Levels Related to Viral Infection, and Inflammatory Response in Tears of Patients Affected by COVID-19 Disease

Study Overview
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Brief Summary
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The aim of this study is to assess the virus RNA, and miRNA levels related to viral infection, and inflammatory response in tears of hospitalized patients with a diagnosis of COVID-19 with and without conjunctivitis and to correlate them with clinical condition. Tears will be collected by using Schirmer Test I, a non invasive painless test which can be performed at the patient's bed. Tears will be collected on the graduated paper strips pulling the lower lid gently downward for 5 minutes. Following, the strip will be placed in a 2.0 mL Eppendorf tube and stored at -80◦C (or - 20°C)

Detailed Description
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The SARS-CoV-2 is a virus highly infectious whose main target of infection is the respiratory tract. Virus has been reported to target other mucus tissues, such as the conjunctiva of the eye and causes conjunctivitis. A recent study has detected the presence of SARS-CoV-2 in the tears of patients affected by COVID-19 with conjunctivitis, using real-time reverse transcription polymerase chain reaction (RT-PCR). This suggests that droplets and body fluids of infected people can contaminate the human conjunctival mucosa and it can be a view of transmission that it must not be ignored. A role of miRNAs has been found in ocular infections such as fungal, bacterial, viral infections. It would be interesting to correlate tear fluid miRNA levels to patients clinical findings

Official Title
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Tear Fluid miRNA Analysis in Sars-Cov2 Conjunctivitis

Conditions
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COVID, Conjunctivitis

Intervention / Treatment
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* Diagnostic Test: Schirmer Test I


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Group 1): A confirmed diagnosis of COVID-19 disease Age ≥ of 18 years. absence of conjuntivitis detected by portable slit lamp Inclusion Criteria (Group 2): A confirmed diagnosis of COVID-19 disease Age ≥ of 18 years. Presence of bilateral conjunctivitis defined as red eyes (macroscopic signs of conjunctival congestion) Exclusion Criteria (both groups): Pregnant women Any form Ocular surface diseases preceding Covid-19 diagnosis, Glaucoma, history of anterior segment inflammation, previous penetrating ocular trauma Ocular surgeries within previous 6 months Topical therapies History of ocular allergy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with bilateral conjunctivitis<br>Hospitalized patient affected by COVID-19 disease with bilateral conjunctivitis defined as red eyes (macroscopic signs of conjunctival congestion) | Diagnostic Test: Schirmer Test I<br>* Collection of tear fluid<br>|
| Patients without conjunctivitis<br>Hospitalized patient affected by COVID-19 disease without any signs of conjunctivitis defined as red eyes (macroscopic signs of conjunctival congestion) | Diagnostic Test: Schirmer Test I<br>* Collection of tear fluid<br>|
| Healthy control group<br>group of healthy patients considered as controls | Diagnostic Test: Schirmer Test I<br>* Collection of tear fluid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| virus molecular analysis | - to asses virus RNA and miRNA levels in tears | 2 weeks | 
| host molecular analysis | - to asses inflammatory response molecules | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidemiologic data | To analyze the prevalence of conjunctivitis in patients with a diagnosis of COVID-19 and the assessment of the predictive value of conjunctivitis in the development of the COVID-19 disease (or in developing respiratory distress forms-ARDS). | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID, conjunctivitis, SARS-CoV2, miRNA, tear fluid