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

COVID Clinical Trial

Official title:

Tear Fluid miRNA Analysis in Sars-Cov2 Conjunctivitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04346160
• Other study ID #: UChieti03
• Status: Not yet recruiting
• Start date: April 14, 2020
• Est. completion date: April 30, 2020

Study information

• Verified date: April 2020
• Source: G. d'Annunzio University
• Contact: Manuela Lanzini, Doctor
• Phone: +393703005156
• Email: m.lanzini[@]unich.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Conjunctivitis
• COVID

Intervention

Diagnostic Test:
• Schirmer Test I
Collection of tear fluid

Locations

Country	Name	City	State
Italy	Ophtalmology Clinic, G.d'Annunzio University	Chieti

Sponsors (1)

Lead Sponsor	Collaborator
G. d'Annunzio University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	virus molecular analysis	- to asses virus RNA and miRNA levels in tears	2 weeks
Primary	host molecular analysis	- to asses inflammatory response molecules	2 weeks
Secondary	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