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

NCT06775457 | Recruiting

• 1 other identifier: HERV_COVID
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

Brief 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. 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.

Conditions

SARS CoV-2; Kawasaki Disease; Retrovirus Infection

Keywords

SARS-COV2; Kawasaki Disease; Human Endogenous Retroviruses

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  through study completion, an average of 1 year

Study Arms (1)

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.

Other: sample collection

Interventions

sample collection OTHER

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.

Patients

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (5)

Ospedale Ramazzini di Carpi, Azienda USL di Modena UO Pediatria

Carpi, Modena, 41012, Italy

RECRUITING

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

Bologna, 40138, Italy

RECRUITING

Azienda Ospedaliera-Universitaria di Modena

Modena, 41100, Italy

RECRUITING

IRCCS Ospedale Pediatrico Bambino Gesù UOC Pediatria Generale

Roma, 00165, Italy

RECRUITING

Ospedale Regina Margherita, Torino, UO Reumatologia Pediatrica

Torino, 10126, Italy

RECRUITING

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome; Retroviridae Infections

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Marianna Fabi, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianna Fabi, MD

CONTACT

0512143012; marianna.fabi@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In vitro prospective, nongenetic human tissue study on biological specimens.

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: January 15, 2025
• Study Start: June 10, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 15, 2025

Record last verified: 2024-10

Locations

IT (5)