Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04346160
Recruitment Status : Not yet recruiting
First Posted : April 15, 2020
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
Leonardo Mastropasqua, 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)


Condition or disease Intervention/treatment
COVID Conjunctivitis Diagnostic Test: Schirmer Test I

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

Layout table for study information
Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Tear Fluid miRNA Analysis in Sars-Cov2 Conjunctivitis
Estimated Study Start Date : April 14, 2020
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye Tears

Group/Cohort Intervention/treatment
Patients with bilateral conjunctivitis
Hospitalized patient affected by COVID-19 disease with bilateral conjunctivitis defined as red eyes (macroscopic signs of conjunctival congestion)
Diagnostic Test: Schirmer Test I
Collection of tear fluid

Patients without conjunctivitis
Hospitalized patient affected by COVID-19 disease without any signs of conjunctivitis defined as red eyes (macroscopic signs of conjunctival congestion)
Diagnostic Test: Schirmer Test I
Collection of tear fluid

Healthy control group
group of healthy patients considered as controls
Diagnostic Test: Schirmer Test I
Collection of tear fluid




Primary Outcome Measures :
  1. virus molecular analysis [ Time Frame: 2 weeks ]
    - to asses virus RNA and miRNA levels in tears

  2. host molecular analysis [ Time Frame: 2 weeks ]
    - to asses inflammatory response molecules


Secondary Outcome Measures :
  1. Epidemiologic data [ Time Frame: 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).


Biospecimen Retention:   Samples With DNA
tear fluid


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04346160


Contacts
Layout table for location contacts
Contact: Manuela Lanzini, Doctor +393703005156 m.lanzini@unich.it

Locations
Layout table for location information
Italy
Ophtalmology Clinic, G.d'Annunzio University
Chieti, Italy, 66013
Sponsors and Collaborators
G. d'Annunzio University
Investigators
Layout table for investigator information
Principal Investigator: Leonardo Mastropasqua, Professor Ophtalmology Clinic, G. d'Annunzio University
Layout table for additonal information
Responsible Party: Leonardo Mastropasqua, Study Director, Professor, G. d'Annunzio University
ClinicalTrials.gov Identifier: NCT04346160    
Other Study ID Numbers: UChieti03
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leonardo Mastropasqua, G. d'Annunzio University:
COVID
conjunctivitis
SARS-CoV2
miRNA
tear fluid
Additional relevant MeSH terms:
Layout table for MeSH terms
Conjunctivitis
Conjunctival Diseases
Eye Diseases