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Completed

NCT Number: NCT05739513

A Specific miRNA Encoded by SARS-CoV-2 as a Diagnostic Tool to Predict Disease Severity in COVID-19 Patients

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 infections.Previous 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 pathogenesis.In 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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mingrone Geltrude

Roma, 00168, Italy

About this study

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 records.Total 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient with Covid -19

Exclusion criteria

  • age < 18 years

Treatment and study plan

miRNA analysis in plasma

Diagnostic Test

blood sample

Primary outcomes

  1. miRNA analysis in plasma

    Time frame: 1 year

    Replicate in our Caucasian cohort previous findings which are under revision in The New England Journal of Medicine, where a miRNA-like small RNA encoded by SARSCoV- 2, has been reported to distinguish severe patients from mild ones and predict the prognosis of COVID-19

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: CoV-miR

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 22, 2023
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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