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.
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.
5 sites in 1 country
Italy5 sites, 5 recruiting
- 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
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.
- Conditions
- SARS CoV-2, Kawasaki Disease, Retrovirus Infection
- 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 group | Role | What they receive |
|---|---|---|
| Patients | Experimental | The 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.
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
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.
- First posted15 Jan 2025
- Study start10 Jun 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV-2Studies of the same condition, open and under way.
- 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
- 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)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marianna Fabi, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
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