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

NCT ID: NCT04346160

Last Updated: 2020-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-14
• Study Completion Date: 2020-04-30

Brief Summary

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

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

Conditions

COVID; Conjunctivitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with bilateral conjunctivitis

Hospitalized patient affected by COVID-19 disease with bilateral conjunctivitis defined as red eyes (macroscopic signs of conjunctival congestion)

Schirmer Test I

Intervention Type: DIAGNOSTIC_TEST

Collection of tear fluid

Patients without conjunctivitis

Hospitalized patient affected by COVID-19 disease without any signs of conjunctivitis defined as red eyes (macroscopic signs of conjunctival congestion)

Schirmer Test I

Intervention Type: DIAGNOSTIC_TEST

Collection of tear fluid

Healthy control group

group of healthy patients considered as controls

Schirmer Test I

Intervention Type: DIAGNOSTIC_TEST

Collection of tear fluid

Interventions

Schirmer Test I

Collection of tear fluid

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• A confirmed diagnosis of COVID-19 disease
• Age ≥ of 18 years.
• absence of conjuntivitis detected by portable slit lamp

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

G. d'Annunzio University

OTHER

Sponsor Role: lead

Responsible Party

Leonardo Mastropasqua

Study Director, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leonardo Mastropasqua, Professor

Role: PRINCIPAL_INVESTIGATOR

Ophtalmology Clinic, G. d'Annunzio University

Locations

Ophtalmology Clinic, G.d'Annunzio University

Chieti, , Italy

Countries

Italy

Central Contacts

Manuela Lanzini, Doctor

Role: CONTACT

m.lanzini@unich.it

+393703005156

Other Identifiers

UChieti03

Identifier Type: -

Identifier Source: org_study_id