Evaluation of Orthohepevirus C Infection as an Emerging Cause of Zoonotic Origin Disease

Maimónides Biomedical Research Institute of Córdoba

Status: Not yet enrolling

Conditions: Chronic Hepatitis; Hepatitis; Liver Disease Chronic; Acute Hepatitis; Liver Diseases

Study type: Observational

Funder types: Other

Identifiers

NCT05062967

PI21/00793

Details and patient eligibility

About

The main objective of this study is to evaluate the prevalence and the clinical impact of Orthohepevirus C infection in different human populations, and to determine its zoonotic origin comparing the sequences obtained in both human and animal populations. This is an ambispective study where Orthohepevirus C infection will be evaluated in four high risk human population: i) patients with acute hepatitis, ii) patients with positive IgM antibody against Hepatitis E virus infection with undetectable viral load, iii) HIV infected individuals, and iv) solid organ transplant recipients. Furthermore, we will analyze three animal populations: i) suburban rodents, ii) domestic rodents, iii) wild carnivores. Viral sequences identified in both human and animal populations will be compared to evaluate the zoonotic origin of the infections.

Full description

To carry out the project a database will be created in electronic format, where the study team will integrate epidemiological, clinical and laboratory tests data of patients. Data will be anonymous and coded by a data manager.

Primary objective is to assess the prevalence of Ortho-C infection in patients with acute hepatitis of no identified origin

Secondary objectives are:

1. To evaluate the prevalence and risk factors of Ortho-C infection in patients with solid organ transplant.
2. To evaluate the prevalence and risk factors of Ortho-C infection in patients with HIV infection.
3. To assess the presence of Ortho-C infection in patients with the presence of antibodies (IgM) against HEV and absence of HEV-RNA
4. To evaluate the prevalence of infection by Ortho-C in wild and periurban rodents.
5. To evaluate the prevalence of infection by Ortho-C in domestic rodents and mustelids.
6. To evaluate the prevalence of infection by Ortho-C in wild carnivores
7. To molecularly characterize and evaluate the degree of homology of Ortho-C viral sequences found in humans and animals

Enrollment: 3,257 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. HAOD cohort (Cohort of patients with acute hepatitis of unknown origin)

• Patients older than 18 years with acute hepatitis of unknown origin (HAOD)

  2. OrthoC-Tx cohort (HEV Screening Cohort in Transplant Patients):

• Kidney or liver transplant subjects

  3. Ortho-CoRIS Cohort (derived from the AIDS Research Network Cohort (CoRIS))

• HIV-infected patients being monitored by the Spanish AIDS Research Network (RIS)

  4. TrazHE Cohort (Traceability cohort of Hepatitis E infections)

• Patients with the presence of antibodies (IgM) against HEV and absence of HEV-RNA

  5. Ortho-C-Rodent Collection:

• Wild and peri-urban rodents (rats) from different areas of Spain

  6. Ortho-C-Domestic Rodent Collection:

• Domestic rodents and mustelids under follow-up in veterinary clinics of different Spanish municipalities.

  7. Ortho-C-Carnivore Collection:

• Wild carnivores that eat rodents collected by the research team since 2020 in 4 autonomous communities (Extremadura, Andalusia, Murcia and Castilla la Mancha)

Trial design

3,257 participants in 7 patient groups

HAOD Cohort

Description:

This cohort includes patients with acute hepatitis of unknown origin, meaning its origin could not be determined after screening of (at least) HAV, HAB, HAC, HAE, Epstein-Barr virus and cytomegalovirus. Patients will be recruited in 17 centres nationwide. The research group will receive a 1mL plasma / serum sample from each patient to study the presence of Ortho-C infection

OrthoC-Tx Cohort

Description:

This cohort includes liver or kidney transplant patients under follow-up. The research group will receive a 1mL plasma / serum sample every year from each patient to study the presence of Ortho-C infection

Ortho-CoRIS Cohort

Description:

This cohort includes VIH positive patients who are in follow-up by the Spanish Network of AIDS Research. The research group will receive a plasma / serum sample every year from each patient to study the presence of Ortho-C infection.

TrazHE Cohort

Description:

This cohort includes patients whose clinical picture is compatible with HAE infection. The presence of Ortho-C infection will be studied in patients with positive IgM for HAE and absence of RNA-HAE.

Ortho-C-Rodent Cohort

Description:

This cohort includes wild rats. Feces and liver samples will be taken in order to determine the prevalence of Ortho-C in wild rats (Ortho-C's main reservoir).

Ortho-C-Domestic Rodent Cohort

Description:

This cohort includes domestic rats and mustelids. Feces and liver samples will be taken in order to determine the prevalence of Ortho-C in domestic rats and mustelids.

Ortho-C-Carnivore Cohort

Description:

This cohort includes 236 wild carnivores that feed off rodents. Carnivores' cause of death is they were run over. Feces, liver and serum samples will be taken to study the transmission of Ortho-C.