NCT04346160

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: G. d'Annunzio University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• COVID
• Conjunctivitis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Schirmer Test I	Collection of tear fluid

Timeline

• Start date: 2020-04-14
• Primary completion: 2020-04-30
• Completion: 2020-04-30
• First posted: 2020-04-15
• Last updated: 2020-04-20

Locations

1 site across 1 country: Italy