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SARS CoV-2HERV_COVIDNCT06775457

Genome Analysis of Human Endogenous Retroviruses (HERVs)(COVID19)

A study testing sample collection in people with SARS CoV-2 and Kawasaki Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 5 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

Human Endogenous Retroviruses (HERVs) are ancient sequences that became integrated into our DNA during evolutionary processes. The significance of their presence in DNA is still being studied, but HERVs appear to be involved in the regulation of the immune response. Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
SARS CoV-2, Kawasaki Disease, Retrovirus Infection
What is being tested?
sample collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
5 sitesItaly
Study dates
10 Jun 2021to 31 Dec 2025
Phase
Interventional

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 Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Pediatric patients, newly diagnosed with Kawasaki disease
  • Pediatric patients, newly diagnosed with Vasculitis
  • Pediatric patients, newly diagnosed with SARS-CoV-2 infection
  • Pediatric patients, newly diagnosed with febrile virosis
  • Pediatric patients with inflammatory diseases with systemic involvement

Who cannot join

  • None

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Marianna Fabi, MD contact

0512143012

marianna.fabi@aosp.bo.it

5 sites in 1 country

Italy5 sites, 5 recruiting
  • IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Pediatria d'Urgenza, Pronto Soccorso e Osservazione Breve ed Intensiva

    Bologna, 40138

    Marianna Fabi, MD, 0512143012, marianna.fabi@aosp.bo.it

    Marianna Fabi, MD

    Recruiting
  • Ospedale Ramazzini di Carpi, Azienda USL di Modena UO Pediatria

    Carpi, Modena, 41012

    Elena Corinaldesi, 0592025805, elcorinaldesi@yahoo.it

    Elena Corinaldesi, MD

    Recruiting
  • Azienda Ospedaliera-Universitaria di Modena

    Modena, 41100

    Lorenzo Iughetti, MD, 0594222182, iughetti.lorenzo@unimore.it

    Lorenzo Iughetti, MD

    Recruiting
  • IRCCS Ospedale Pediatrico Bambino Gesù UOC Pediatria Generale

    Roma, 00165

    Alessandra Marchesi, MD, 06 6859 4784, alessandra.marchesi@opbg.net

    Alessandra Marchesi, MD

    Recruiting
  • Ospedale Regina Margherita, Torino, UO Reumatologia Pediatrica

    Torino, 10126

    Francesco Licciardi, MD, 011 633 1633, francesco.licciardi@cittadellasalute.to.it

    Francesco Licciardi, MD

    Recruiting

Other trials in Italy

About this study

Official title: Genome Analysis of Human Endogenous Retroviruses (HERVs) and Gut Microbiota in Patients With SARS-CoV-2 Infection, Kawasaki Disease and Other Febrile and Inflammatory Diseases With Systemic Involvement in Pediatric Age.

Human Endogenous Retroviruses (HERVs) are ancient sequences that became integrated into our DNA during evolutionary processes.

The significance of their presence in DNA is still being studied, but HERVs appear to be involved in the regulation of the immune response.

Read more

The gut microbiota is the set of microorganisms that physiologically colonize the gastrointestinal tract. Progressively increasing attention is being paid to the gut microbiota and its potential role in diseases of various kinds. In particular, it has recently been shown how abnormalities in the microbiota can affect immune regulation by determining the occurrence of certain diseases. One objective of the study is to evaluate whether there is an association between the expression of HERVs and clinical manifestations in pediatric age in patients with various diseases such as Kawasaki Disease, IgA Vasculitis/Schonlein-Henoch's Purpura, SARS-CoV-2 infection, or, finally, febrile virosis.

Another objective of the study is to evaluate whether there is an association between the presence of particular types of bacteria in the gut microbiota and clinical manifestations in pediatric age in patients with Kawasaki Disease, IgA Vasculitis/Schonlein-Henoch purpura, SARS-CoV-2 infection or febrile virosis.

The results from this may open new perspectives for both the care and therapeutic management of children with these diseases.

Read the detailed description

The literature provides us with indications that HERVs have been found to be implicated in the pathogenesis of numerous complex diseases, characterized by a multifactorial etiology on a genetic susceptibility basis. Indeed, it is hypothesized that HERVs may represent the link between genetic risk factors and infectious/environmental factors, thus contributing to the onset and/or progression of these diseases. It has also been pointed out that there is an interaction between HERVs and cytokines, in that reactivation of HERVs appears to shape the innate immune response, evoking the production of pro-inflammatory cytokines, and conversely, inflammatory effectors could in turn be responsible for further increasing HERVs activity. A similar point can be made regarding the gut microbiota and its potential role in modulating both innate and adaptive immune responses.

An imbalance of gut microbiota (GM), thus of host-GM homeostasis, as a result of various environmental stimuli ( antibiotic intake, diet, geographic area...), may alter the immune system response favoring in some cases an aberrant immune response by modulating the innate and adaptive immune system (IS). It can influence inflammasome function in innate immune cells and enterocytes, either through a direct interaction between GM and immune cells, or through the production of metabolites (lipopolysaccharides, peptidoglycans, microbial nucleic acids, glucans, and mannans) that regulate IS function. Short-chain fatty acids, produced by fermentation of lipopolysaccharides from GM exert an important role on the host IS: butyrate modifies the cytokine production profile of helper T cells and promotes the integrity of the intestinal epithelium, while acetate promotes the resolution of intestinal inflammation. Based on this rationale, we intend to conduct a study of patients with Kawasaki disease (KD), IgA vasculitis/Schonlein-Henoch purpura, SARS-CoV-2 infection, and febrile virosis in pediatric age. Particularly in Kawasaki disease, the study could identify in HERVs a causative/favorable role in disease onset and identify individuals at higher risk of severe form in terms of cardiac injury and response to conventional therapy, and contribute the identification of possible new therapeutic targets. The increased expression of HERVs could, in fact, identify subjects at higher risk for a severe form, who could benefit from additional personalized therapy early on and closer cardiologic instrumental follow-up for coronary lesions. Relative to IgA vasculitis/Schonlein-Henoch purpura, determination of altered transcriptional activity of HERVs in affected subjects could help define a prognostic factor of severe pictures. We also intend to compare the characteristics of affected subjects with those of KD patients, given the vasculitic nature of both diseases, to highlight differences or similarities in expression. In pediatric SARS-CoV-2 infection, we believe that the study of the expression of HERVs may be a useful aid in explaining the increased susceptibility of some individuals to development of severe disease pictures, especially the development of MIS-C picture. In inclusion of subjects with significant febrile virosis pictures, such as to require hospitalization, is aimed both at identifying possible patterns of predisposition for the development of systemic pictures in the context of viral infections and to compare clinical-laboratory features with respect to patients with symptomatic SARS-CoV-2 infection. Similarly, in each of the categories of patients previously described, we believe that analysis of GM can help determine whether particular profiles and characteristics may condition different disease pictures through modulation of immune response and by maintaining intestinal mucosal integrity.

Being tested
sample collection
Keywords
SARS-COV2, Kawasaki Disease, Human Endogenous Retroviruses
Medical subject headings
Mucocutaneous Lymph Node Syndrome, Retroviridae Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sample collectionOther

    Blood samples and fecal samples will be taken from patients during evaluation visits. Blood samples will be analyzed for the study of HERVs. While fecal samples will be analyzed for the characterization of gut microbiota.

Study groups in NCT06775457
Study groupRoleWhat they receive
PatientsExperimentalThe study will be offered consecutively to each patient in whom Kawasaki Disease, Schonlein-Henoch purpura, symptomatic SARS-CoV-2 infection, febrile virosis, and with inflammatory diseases with systemic involvement are diagnosed.
Receives: Other: sample collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HERVs analysis

    Investigate the expression levels of specific HERVs families in PBMCs of patients with Kawasaki disease, IgA vasculitis/Schonlein-Henoch purpura, SARS- CoV-2 infection, and febrile virosis and inflammatory diseases with systemic involvement in pediatric age.

    Measured: through study completion, an average of 1 year

  2. Microbiota characterization

    Characterize the MI composition of subjects with Kawasaki disease, IgA vasculitis/Schonlein-Henoch's purpura, SARS-CoV-2 infection, and febrile virosis and inflammatory diseases with systemic involvement in pediatric age included by culture-independent method (16S rRNA gene sequencing).

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2025
  2. Study start10 Jun 2021
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
In vitro prospective, nongenetic human tissue study on biological specimens.
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06775457
Sponsor's protocol ID
HERV_COVID
Acronym
HERV_COVID
Status last verified
Oct 2024
First submitted
1 Dec 2024
Last updated
15 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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