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

• Conditions: COVID; Conjunctivitis
• Interventions: Diagnostic Test: Schirmer Test I

• Registration Number: NCT04346160
• Lead Sponsor: G. d'Annunzio University

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

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-10
• Study Start: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-15
• Last Update Submitted: 2020-04-16
• Last Update Posted: 2020-04-20
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with bilateral conjunctivitis	Schirmer Test I	Hospitalized patient affected by COVID-19 disease with bilateral conjunctivitis defined as red eyes (macroscopic signs of conjunctival congestion)
Patients without conjunctivitis	Schirmer Test I	Hospitalized patient affected by COVID-19 disease without any signs of conjunctivitis defined as red eyes (macroscopic signs of conjunctival congestion)
Healthy control group	Schirmer Test I	group of healthy patients considered as controls

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

Ophtalmology Clinic, G.d'Annunzio University; 🇮🇹 Chieti, Italy