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

NCT05739513 | Completed

• 1 other identifier: 3446
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• miRNA analysis in plasma

  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

  1 year

Study Arms (2)

Patients with COVID-19

OTHER

blood sampling for miRNA analysis

Diagnostic Test: miRNA analysis in plasma

Patients without COVID-19

OTHER

blood sampling for miRNA analysis

Diagnostic Test: miRNA analysis in plasma

Interventions

miRNA analysis in plasma DIAGNOSTIC_TEST

blood sample

Patients with COVID-19; Patients without COVID-19

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient with Covid -19

You may not qualify if:

• age \< 18 years

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Mingrone Geltrude

Roma, 00168, Italy

Location

Related Publications (10)

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  PMID: 32397911 BACKGROUND

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  PMID: 32234466 BACKGROUND

• Tu YF, Chien CS, Yarmishyn AA, Lin YY, Luo YH, Lin YT, Lai WY, Yang DM, Chou SJ, Yang YP, Wang ML, Chiou SH. A Review of SARS-CoV-2 and the Ongoing Clinical Trials. Int J Mol Sci. 2020 Apr 10;21(7):2657. doi: 10.3390/ijms21072657.

  PMID: 32290293 BACKGROUND

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  PMID: 32286245 BACKGROUND

• Ortega FJ, Mercader JM, Catalan V, Moreno-Navarrete JM, Pueyo N, Sabater M, Gomez-Ambrosi J, Anglada R, Fernandez-Formoso JA, Ricart W, Fruhbeck G, Fernandez-Real JM. Targeting the circulating microRNA signature of obesity. Clin Chem. 2013 May;59(5):781-92. doi: 10.1373/clinchem.2012.195776. Epub 2013 Feb 8.

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  PMID: 24973316 BACKGROUND

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  PMID: 18668037 BACKGROUND

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  PMID: 32420944 BACKGROUND

• Pfeffer S, Zavolan M, Grasser FA, Chien M, Russo JJ, Ju J, John B, Enright AJ, Marks D, Sander C, Tuschl T. Identification of virus-encoded microRNAs. Science. 2004 Apr 30;304(5671):734-6. doi: 10.1126/science.1096781.

  PMID: 15118162 BACKGROUND

• Morales L, Oliveros JC, Fernandez-Delgado R, tenOever BR, Enjuanes L, Sola I. SARS-CoV-Encoded Small RNAs Contribute to Infection-Associated Lung Pathology. Cell Host Microbe. 2017 Mar 8;21(3):344-355. doi: 10.1016/j.chom.2017.01.015. Epub 2017 Feb 16.

  PMID: 28216251 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• geltrude mingrone, professor

  Policlinico A. Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: February 22, 2023
• Study Start: December 7, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 12, 2021
• Last Updated: March 17, 2023

Record last verified: 2023-03

Locations

IT (1)