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

Tear Fluid miRNA Analysis in Sars-Cov2 Conjunctivitis

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)

Study Overview

• Status: Unknown
• Conditions: Conjunctivitis; COVID
• Intervention / Treatment: Diagnostic test: Schirmer Test I

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

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

• Study Contact: Name: Manuela Lanzini, Doctor; Phone Number: +393703005156; Email: m.lanzini@unich.it

Study Locations

• Italy
  • Chieti, Italy, 66013
    • Ophtalmology Clinic, G.d'Annunzio University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

a total of 25 patients with a diagnosis of COVID-19 with bilateral conjunctivitis (Group 1) and without conjunctivitis (Group 2) will be enrolled at the Anesthesia and Intensive Care department, the Infectious diseases department and the Emergency Medicine department, at the "SS. Annunziata Hospital" of Chieti-University G. D'Annunzio, Chieti-Pescara, Italy, in April 2020. A group of healthy patients will be enrolled and were considered as controls

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with bilateral conjunctivitis; Hospitalized patient affected by COVID-19 disease with bilateral conjunctivitis defined as red eyes (macroscopic signs of conjunctival congestion)	Diagnostic test: Schirmer Test I; 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)	Diagnostic test: Schirmer Test I; Collection of tear fluid
Healthy control group; group of healthy patients considered as controls	Diagnostic test: Schirmer Test I; Collection of tear fluid

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: G. d'Annunzio University
• Investigators: Principal Investigator: Leonardo Mastropasqua, Professor, Ophtalmology Clinic, G. d'Annunzio University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 14, 2020
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): April 30, 2020

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): April 20, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: COVID; miRNA; conjunctivitis; SARS-CoV2; tear fluid
• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases; Conjunctivitis
• Other Study ID Numbers: UChieti03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No