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COVID-T: COVID-19 Search in Conjunctival Cells

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Completed
CT.gov ID
NCT04364594
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
2.1
Actual Duration (Months)
23.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The patients enrolled in this study will be all patients entering triage with suspicion of SARS-CoV2. Planned activities are required by the nasopharyngeal swab in parallel with the analysis of the conjunctival swab to identify new potential alternative and equally effective diagnostic pathways.

Simultaneously systemic data (as Pulmonary images, hematological parameters etc.) will be collected to observe a possible correlation between conjunctival swab positivity and systemic impairment.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: conjunctival swab
 N/A

Detailed Description

In recent months, considerable interest has turned to Coronavirus infection in terms of early diagnosis and targeted therapy. Thanks to the experimentation of new therapeutic strategies, it becomes more and more evident how some subgroups of patients can benefit from a specific treatment, while others would have no benefit.

Alongside these innovative clinical research techniques, early diagnosis that would lead to identifying those at risk of a new disease and new infection is becoming increasingly important.

COVID-19 occurred in China in December 2019 but probably already had an expression in the previous months. The number of victims reached its peak in January 2020 with prevalent involvement of patients already at risk or with previous physical debilitations. But even apparently healthy and young individuals can be affected by infections with a lethal outcome. Since January 2020 new cases have been registered all over the world and prevalently in Italy. The main way of infection identified is the respiratory tract, but infection through conjunctival may not be excluded.

The main outcome of this research is to investigate the positivity of the COVID-19 virus in the conjunctival mucosa to establish a new diagnostic target.

All patients will receive both the conjunctival swab and nasopharyngeal swab. The conjunctival swab will be performed in each eye and both swabs will be inserted into the same virus test tube. The swab samples will be sent in the same day to the microbiology laboratory for examination by Real Time-PCR.

The secondary outcome will be to evaluate the possible positivity of the conjunctival swab with the degree of systemic impairment. This objective has the purpose of personalized medicine.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2): Diagnostic Targets for Customized Medicine.
Actual Study Start Date :
Mar 26, 2020
Actual Primary Completion Date :
Apr 24, 2020
Actual Study Completion Date :
May 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: affected individual

Patients affected by Coronavirus 19 admitted to the hospital setting

Diagnostic Test: conjunctival swab
analysis of conjunctival cells (real time PCR) collected by conjunctival swabs in both eyes
Other Names:
  • Pulmonary involvement determined by X-Ray (XR) rays and Computed Tomography (CT) scan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Conjunctival swab results based on RT-PCR [2 months]

      Collection of conjunctival cell samples from eyes of COVID-19 patients. Analysis of conjunctival cells by real-time PCR to document presence of COVID-19. Binary outcome: yes, no. To evaluate the result in relation to nasopharyngeal swab (binary outcome yes, no) and to correlate conjunctival with nasopharyngeal swab positivity

    Secondary Outcome Measures

    1. Conjunctival swab positivity in relation to Pulmonary and blood abnormalities [2 months]

      To evaluate the agreement between conjunctival swab positivity and the degree of systemic impairment. The latter will be measured on the basis of pulmonary disease severity as assessed by a standardized scale (Occhipinti et al 2019) for interstitial lung involvement in systemic sclerosis; the blood measurements of d-dimer, LDH and reactive CP.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients accepted to triage with positivity or suspected positivity to COVID-19 will be enrolled in the study and both conjunctival and nasopharyngeal swab will be performed.
    Exclusion Criteria:
    • To date, there are no exclusion criteria

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maria Cristina Savastano Roma Italy 00198

    Sponsors and Collaborators

    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    ClinicalTrials.gov Identifier:
    NCT04364594
    Other Study ID Numbers:
    • 0013008/20
    First Posted:
    Apr 28, 2020
    Last Update Posted:
    Jul 23, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    Conjunctival swabs
    Diagnosis
    SARS-CoV2
    Systemic Impairment
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Jul 23, 2020