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

G. d'Annunzio University

Status: Unknown

Conditions: Conjunctivitis; COVID

Treatments: Diagnostic Test: Schirmer Test I

Study type: Observational

Funder types: Other

Identifiers

NCT04346160

UChieti03

Details and patient eligibility

About

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)

Full 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

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

25 participants in 3 patient groups

Patients with bilateral conjunctivitis

Description:

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

Treatment:

Diagnostic Test: Schirmer Test I

Patients without conjunctivitis

Description:

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

Treatment:

Diagnostic Test: Schirmer Test I

Healthy control group

Description:

group of healthy patients considered as controls

Treatment:

Diagnostic Test: Schirmer Test I