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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04346160

Enrollment

Registered

2020-04-15

Start date

2020-04-14

Completion date

2020-04-30

Last updated

2020-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conjunctivitis, COVID

Keywords

COVID, conjunctivitis, SARS-CoV2, miRNA, tear fluid

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

Interventions

DIAGNOSTIC_TESTSchirmer Test I

Collection of tear fluid

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

Italy

Contacts

Primary ContactManuela Lanzini, Doctor

m.lanzini@unich.it+393703005156

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026