NCT04346160

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

April 14, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

16 days

First QC Date

April 10, 2020

Last Update Submit

April 16, 2020

Conditions

COVIDConjunctivitis

Keywords

COVIDconjunctivitisSARS-CoV2miRNAtear fluid

Outcome Measures

Primary Outcomes (2)

  • virus molecular analysis

    \- to asses virus RNA and miRNA levels in tears

    2 weeks

  • host molecular analysis

    \- to asses inflammatory response molecules

    2 weeks

Secondary Outcomes (1)

  • Epidemiologic data

    2 weeks

Study Arms (3)

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

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

Healthy control group

group of healthy patients considered as controls

Diagnostic Test: Schirmer Test I

Interventions

Schirmer Test IDIAGNOSTIC_TEST

Collection of tear fluid

Healthy control groupPatients with bilateral conjunctivitisPatients without conjunctivitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • A confirmed diagnosis of COVID-19 disease
  • Age ≥ of 18 years.
  • absence of conjuntivitis detected by portable slit lamp
  • A confirmed diagnosis of COVID-19 disease
  • Age ≥ of 18 years.
  • Presence of bilateral conjunctivitis defined as red eyes (macroscopic signs of conjunctival congestion)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophtalmology Clinic, G.d'Annunzio University

Chieti, 66013, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

tear fluid

MeSH Terms

Conditions

Conjunctivitis

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye Diseases

Study Officials

  • Leonardo Mastropasqua, Professor

    Ophtalmology Clinic, G. d'Annunzio University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuela Lanzini, Doctor

CONTACT

+393703005156m.lanzini@unich.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director, Professor

Study Record Dates

First Submitted

April 10, 2020

First Posted

April 15, 2020

Study Start

April 14, 2020

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

April 20, 2020

Record last verified: 2020-04

Locations

IT(1)