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

Sponsor

G. d'Annunzio University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04346160

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Days)

47.6

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
COVID Conjunctivitis	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 Design

Study Type:

Observational

Anticipated Enrollment :

25 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Tear Fluid miRNA Analysis in Sars-Cov2 Conjunctivitis

Anticipated Study Start Date :

Apr 14, 2020

Anticipated Primary Completion Date :

Apr 30, 2020

Anticipated Study Completion Date :

Apr 30, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

virus molecular analysis [2 weeks]
- to asses virus RNA and miRNA levels in tears
host molecular analysis [2 weeks]
- to asses inflammatory response molecules

Secondary Outcome Measures

Epidemiologic data [2 weeks]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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