Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05739513
Status:
COMPLETED
Last Update Posted:
2023-03-17
First Post:
2023-02-21
Brief Title:
A Specific miRNA Encoded by SARS-CoV-2 as a Diagnostic Tool to Predict Disease Severity in COVID-19 Patients
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
A Specific miRNA Encoded by SARS-CoV-2 as a Diagnostic Tool to Predict Disease Severity in COVID-19 Patients
Status:
COMPLETED
Status Verified Date:
2023-03
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:
CoV-miR
Brief Summary:
Coronavirus disease is caused by SARS-CoV-2 known as 2019 novel coronavirus 2019-nCoV To date has caused a large number of deaths causing serious respiratory illness such as pneumonia and lung failure therefore representing a serious threat to public health The etiological agent belongs to the subfamily Orthocoronavirinae in the family Coronaviridae Order Nidovirales The genome of coronaviruses is composed of an enveloped positive-sense single-stranded RNA with a size varying between 26 kb and 32 kb becoming the largest genome of known RNA viruses so far Similar to RNA viruses this family is characterized by genetic variability and high recombination rate that enable them to be easily distributed among humans and animals worldwide Considering the huge impact of the pandemic it is urgent to gain understanding and to build strategies to contain the viral spread To date different diagnostic kits for testing the illness are available Besides diagnosis the prediction of the severity and prognosis of COVID-19 is essential to stratify patients and allocate them in the adequate medical facilities so as to reduce mortality rates It has been reported that microRNAs miRNAs are valuable biomarkers for disease diagnosis prognosis and classification MiRNAs are defined as a class of non-coding RNAs that are able to regulate gene expression by specific binding to complementary regions in coding messenger RNAs leading to translational repression or decay Not only that but also they can be important modulators of viral infectionsPrevious studies have revealed the presence of miRNA-like small RNAs milRNAs which can be encoded by RNA viruses and can actively disrupt the host innate immune responses in order to create a favourable environment for viral replication On the other side cellular miRNAs can also play a role on virus replication and pathogenesisIn this case this pilot project is aimed at their valuable diagnostic potential in order to diagnose and stratify patients under viral infection The project came up after receiving information from a Chinese research group requesting their results to be replicated in Caucasian population The ROC curves were constructed to demonstrate the accuracy of this specific miRNA in COVID-19 patient stratification and discerning between severe patients from healthy controls Both ROC curves suggested the miRNA as precise biomarker for differential diagnosis and prognosis of disease severity
Detailed Description:
It will include 120 patients with and without COVID-19 According to the World Health Organization guidance all patients with COVID-19 enrolled in the study were diagnosed bythe throat swab and RT-PCR method Patient information was collected from medical recordsTotal RNA content will be extracted from plasma samples by methods aimed at preserving and isolating small RNA molecules The kit used will be mirVANATM PARISTM Isolation Kit Applied Biosystems Darmstadt Germany The mirVANATM PARISTM Kit begins with homogenization of samples with a special cell disruption buffer and RNA isolation is performed using a procedure that combines the advantages of organic and solid-phase extraction Once extracted a fixed volume of RNA solution will be used as the input for the reverse transcription reaction using the TaqMan MicroRNA Reverse Transcription Kit Applied Biosystems Darmstadt Germany The product will be further amplified by real-time PCR using specific primers for the detection of the milRNA previously validated by means of the LightCycler 480 Real-Time PCR System Roche Diagnostics Barcelona Spain
Study Oversight
Has Oversight DMC:
None
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?:
None