Clinical trial 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
Official title: Tear Fluid miRNA Analysis in Sars-Cov2 Conjunctivitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID
Conjunctivitis
Keywords: COVID
conjunctivitis
SARS-CoV2
miRNA
tear fluid
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: a total of 25 patients with a diagnosis of COVID-19 with bilateral conjunctivitis (Group 1) and without conjunctivitis (Group 2) will be enrolled at the Anesthesia and Intensive Care department, the Infectious diseases department and the Emergency Medicine department, at the "SS. Annunziata Hospital" of Chieti-University G. D'Annunzio, Chieti-Pescara, Italy, in April 2020. A group of healthy patients will be enrolled and were considered as controls

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

Eligibility criteria: 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

Primary outcomes:
measure: virus molecular analysis
timeFrame: 2 weeks
measure: host molecular analysis
timeFrame: 2 weeks
Secondary outcomes:
measure: Epidemiologic data
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Ophtalmology Clinic, G.d'Annunzio University
Study officials:
affiliation: Ophtalmology Clinic, G. d'Annunzio University
name: Leonardo Mastropasqua, Professor
role: PRINCIPAL_INVESTIGATOR
References: