COVID-19CoV-miRNCT05739513
A Specific miRNA Encoded by SARS-CoV-2 as a Diagnostic Tool to Predict Disease Severity in COVID-19 Patients
A study testing miRNA analysis in plasma in people with COVID-19, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COVID-19
- What is being tested?
- miRNA analysis in plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 7 Dec 2020to 12 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with Covid -19
Who cannot join
- age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 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).
- Conditions
- COVID-19
- Being tested
- miRNA analysis in plasma
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miRNA analysis in plasmaDiagnostic test
blood sample
| Study group | Role | What they receive |
|---|---|---|
| Patients with COVID-19 | Other | blood sampling for miRNA analysis Receives: Diagnostic Test: miRNA analysis in plasma |
| Patients without COVID-19 | Other | blood sampling for miRNA analysis Receives: Diagnostic Test: miRNA analysis in plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start7 Dec 2020
- Primary completion1 Jul 2021
- Study completion12 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingrone Geltrude, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- geltrude mingrone, professor, Principal investigator, Policlinico A. Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739513
- Sponsor's protocol ID
- 3446
- Acronym
- CoV-miR
- Status last verified
- Mar 2023
- First submitted
- 21 Feb 2023
- Last updated
- 17 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Amawi H, Abu Deiab GI, A Aljabali AA, Dua K, Tambuwala MM. COVID-19 pandemic: an overview of epidemiology, pathogenesis, diagnostics and potential vaccines and therapeutics. Ther Deliv. 2020 Apr;11(4):245-268. doi: 10.4155/tde-2020-0035. Epub 2020 May 12.
PubMed 32397911Li H, Liu SM, Yu XH, Tang SL, Tang CK. Coronavirus disease 2019 (COVID-19): current status and future perspectives. Int J Antimicrob Agents. 2020 May;55(5):105951. doi: 10.1016/j.ijantimicag.2020.105951. Epub 2020 Mar 29.
PubMed 32234466Tu 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.
PubMed 32290293Henry BM, de Oliveira MHS, Benoit S, Plebani M, Lippi G. Hematologic, biochemical and immune biomarker abnormalities associated with severe illness and mortality in coronavirus disease 2019 (COVID-19): a meta-analysis. Clin Chem Lab Med. 2020 Jun 25;58(7):1021-1028. doi: 10.1515/cclm-2020-0369.
PubMed 32286245Ortega 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.
PubMed 23396142Pirola CJ, Fernandez Gianotti T, Castano GO, Mallardi P, San Martino J, Mora Gonzalez Lopez Ledesma M, Flichman D, Mirshahi F, Sanyal AJ, Sookoian S. Circulating microRNA signature in non-alcoholic fatty liver disease: from serum non-coding RNAs to liver histology and disease pathogenesis. Gut. 2015 May;64(5):800-12. doi: 10.1136/gutjnl-2014-306996. Epub 2014 Jun 27.
PubMed 24973316Baek D, Villen J, Shin C, Camargo FD, Gygi SP, Bartel DP. The impact of microRNAs on protein output. Nature. 2008 Sep 4;455(7209):64-71. doi: 10.1038/nature07242. Epub 2008 Jul 30.
PubMed 18668037Canatan D, De Sanctis V. The impact of MicroRNAs (miRNAs) on the genotype of coronaviruses. Acta Biomed. 2020 May 11;91(2):195-198. doi: 10.23750/abm.v91i2.9534.
PubMed 32420944Pfeffer 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.
PubMed 15118162Morales 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.
PubMed 28216251
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Specific miRNA Encoded by SARS-CoV-2 as a Diagnostic Tool to Predict Disease Severity in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT05739513
- Acronym / sponsor ID
- CoV-miR / 3446
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 12 Jul 2021 (actual)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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).
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with COVID-19 | Other | Diagnostic Test: miRNA analysis in plasmablood sampling for miRNA analysis |
| Patients without COVID-19 | Other | Diagnostic Test: miRNA analysis in plasmablood sampling for miRNA analysis |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient with Covid -19
Key exclusion criteria (1 listed)
- age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| miRNA analysis in plasmablood sample | Diagnostic test | Patients with COVID-19, Patients without COVID-19 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Background: PubMed 32397911Amawi H, Abu Deiab GI, A Aljabali AA, Dua K, Tambuwala MM. COVID-19 pandemic: an overview of epidemiology, pathogenesis, diagnostics and potential vaccines and therapeutics. Ther Deliv. 2020 Apr;11(4):245-268. doi: 10.4155/tde-2020-0035. Epub 2020 May 12.
- Background: PubMed 32234466Li H, Liu SM, Yu XH, Tang SL, Tang CK. Coronavirus disease 2019 (COVID-19): current status and future perspectives. Int J Antimicrob Agents. 2020 May;55(5):105951. doi: 10.1016/j.ijantimicag.2020.105951. Epub 2020 Mar 29.
- Background: PubMed 32290293Tu 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.
- Background: PubMed 32286245Henry BM, de Oliveira MHS, Benoit S, Plebani M, Lippi G. Hematologic, biochemical and immune biomarker abnormalities associated with severe illness and mortality in coronavirus disease 2019 (COVID-19): a meta-analysis. Clin Chem Lab Med. 2020 Jun 25;58(7):1021-1028. doi: 10.1515/cclm-2020-0369.
- Background: PubMed 23396142Ortega 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.
- Background: PubMed 24973316Pirola CJ, Fernandez Gianotti T, Castano GO, Mallardi P, San Martino J, Mora Gonzalez Lopez Ledesma M, Flichman D, Mirshahi F, Sanyal AJ, Sookoian S. Circulating microRNA signature in non-alcoholic fatty liver disease: from serum non-coding RNAs to liver histology and disease pathogenesis. Gut. 2015 May;64(5):800-12. doi: 10.1136/gutjnl-2014-306996. Epub 2014 Jun 27.
- Background: PubMed 18668037Baek D, Villen J, Shin C, Camargo FD, Gygi SP, Bartel DP. The impact of microRNAs on protein output. Nature. 2008 Sep 4;455(7209):64-71. doi: 10.1038/nature07242. Epub 2008 Jul 30.
- Background: PubMed 32420944Canatan D, De Sanctis V. The impact of MicroRNAs (miRNAs) on the genotype of coronaviruses. Acta Biomed. 2020 May 11;91(2):195-198. doi: 10.23750/abm.v91i2.9534.
- Background: PubMed 15118162Pfeffer 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.
- Background: PubMed 28216251Morales 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
geltrude mingrone, professor principal investigator
Policlinico A. Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing miRNA analysis in plasma in people with COVID-19, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
miRNA analysis in plasma (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05739513, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.