COVID-19 Search in Conjunctival Cells (COVID-T)
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|ClinicalTrials.gov Identifier: NCT04364594|
Recruitment Status : Completed
First Posted : April 28, 2020
Last Update Posted : July 23, 2020
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|
|COVID 19 Pulmonary Disease||Diagnostic Test: conjunctival swab||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2): Diagnostic Targets for Customized Medicine.|
|Actual Study Start Date :||March 26, 2020|
|Actual Primary Completion Date :||April 24, 2020|
|Actual Study Completion Date :||May 30, 2020|
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 Name: Pulmonary involvement determined by X-Ray (XR) rays and Computed Tomography (CT) scan
- Conjunctival swab results based on RT-PCR [ Time Frame: 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
- Conjunctival swab positivity in relation to Pulmonary and blood abnormalities [ Time Frame: 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.
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): NCT04364594
|Maria Cristina Savastano|
|Roma, Italy, 00198|