COVID-19 Search in Conjunctival Cells (COVID-T)
Primary Purpose
COVID 19, Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
conjunctival swab
Sponsored by
About this trial
This is an interventional diagnostic trial for COVID 19 focused on measuring Conjunctival swabs, Diagnosis, SARS-CoV2, Systemic Impairment
Eligibility Criteria
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
Sites / Locations
- Maria Cristina Savastano
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
affected individual
Arm Description
Patients affected by Coronavirus 19 admitted to the hospital setting
Outcomes
Primary Outcome Measures
Conjunctival swab results based on RT-PCR
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
Conjunctival swab positivity in relation to Pulmonary and blood abnormalities
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.
Full Information
NCT ID
NCT04364594
First Posted
April 22, 2020
Last Updated
July 22, 2020
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT04364594
Brief Title
COVID-19 Search in Conjunctival Cells
Acronym
COVID-T
Official Title
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2): Diagnostic Targets for Customized Medicine.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 26, 2020 (Actual)
Primary Completion Date
April 24, 2020 (Actual)
Study Completion Date
May 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID 19, Pulmonary Disease
Keywords
Conjunctival swabs, Diagnosis, SARS-CoV2, Systemic Impairment
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
affected individual
Arm Type
Experimental
Arm Description
Patients affected by Coronavirus 19 admitted to the hospital setting
Intervention Type
Diagnostic Test
Intervention Name(s)
conjunctival swab
Other Intervention Name(s)
Pulmonary involvement determined by X-Ray (XR) rays and Computed Tomography (CT) scan
Intervention Description
analysis of conjunctival cells (real time PCR) collected by conjunctival swabs in both eyes
Primary Outcome Measure Information:
Title
Conjunctival swab results based on RT-PCR
Description
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
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Conjunctival swab positivity in relation to Pulmonary and blood abnormalities
Description
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.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Maria Cristina Savastano
City
Roma
ZIP/Postal Code
00198
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study Protocol approved by Ethical Committee, informed consent, clinical study report, will be available
IPD Sharing Time Frame
The data will be available immediately after the statistical analysis of the results and will remain available for at least 1 year
IPD Sharing Access Criteria
On request by e-mail
Citations:
PubMed Identifier
30861018
Citation
Occhipinti M, Bosello S, Sisti LG, Cicchetti G, de Waure C, Pirronti T, Ferraccioli G, Gremese E, Larici AR. Quantitative and semi-quantitative computed tomography analysis of interstitial lung disease associated with systemic sclerosis: A longitudinal evaluation of pulmonary parenchyma and vessels. PLoS One. 2019 Mar 12;14(3):e0213444. doi: 10.1371/journal.pone.0213444. eCollection 2019.
Results Reference
background
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COVID-19 Search in Conjunctival Cells
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