Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT04364594
Status:
COMPLETED
Last Update Posted:
2020-07-23
First Post:
2020-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 Search in Conjunctival Cells
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Study Overview
Official Title:
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2): Diagnostic Targets for Customized Medicine.
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVID-T
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: