OBSERVATIONAL STUDY ON VIRAL SHEDDING AND IMMUNOLOGICAL RESPONSE OF OROPOUCHE VIRUS (OROVIMM)

This is a single-center observational study, whose primary objective is to describe the immune response to Oropouche Virus (OROV) during the study period and the duration of viral RNA shedding, only for sequential samples, by RT-PCR in different matrices.

Study Overview

• Status: Recruiting
• Conditions: Oropouche Infection

Detailed Description

This is a study with retrospective and prospective enrollment.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Elvia Malo; Phone Number: +390456013111; Email: ricerca.clinica@sacrocuore.it

Study Locations

• Italy
  • VR
    • Negrar, VR, Italy, 37024
      • Recruiting
      • IRCCS Sacro Cuore Don Calabria
      • Contact: Concetta Castilletti; Phone Number: +39(0)456013111; Email: concetta.castilletti@sacrocuore.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult patients (age 18 years or over) with RT-PCR-confirmed OROV, who attended or will attend health services at the Center.

Description

Inclusion Criteria:

• patients resulted positive to the RT-PCR for OROV;
• informed consent to the participation to the study and to personal data's treatment and/or donation of residual samples to Tropika Biobank;
• patients ≥ 18 years old.

Exclusion Criteria

• lack of signed informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

OROV patients; The study population will consist of adult patients (age 18 years or over) with RT-PCR-confirmed OROV, who attended or will attend health services at DITM. During first clinical encounter, study participants will be interviewed and physically examined as part of routine clinical practice, in this occasion patients will be also approached to obtain informed consent by their attending physician; all the patients will also be asked the consent for the donation of residual samples from routine diagnostic tests to Tropica BioBank. RT-PCR and culture testing will be repeated at each clinical visit and will stop when one negative RT-PCR results from all matrices have been obtained. Immunologic testing will continue for the duration of the study. Subject participation duration will be about 3 months in total.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-OROV serum antibody response	Results of the anti-OROV serum antibody response along the study period: IgM (titer, reciprocal of dilution);; IgG (titer, reciprocal of dilution).	Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
OROV viral RNA shedding in different matrices	Results of OROV viral RNA presence in different matrice along the study period: RT-PCR Ct and RNA copies/mL in different matrices: urine, whole blood, serum, vaginal swab or seminal fluid, CSF and amniotic fluid if available.	Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of anti-OROV humoral response	Results of the anti-OROV neutralizing antibody response along the study period: neutralizing antibodies titer (titer, reciprocal of dilution).	Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO.
Quality of anti-OROV cell mediated immunity evolution	Results of the quality of anti-OROV cell mediatedimmune response along the study period: specific cell-mediated response (specific IFN producing cells/100,000).	Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Quality of anti-OROV cytokine production	Results of the quality of anti-OROV cytokine production profile along the study period: cytokine analysis (pg/ml)	Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO.
Timing evolution of humoral OROV specific response	IgM and IgG kinetics (days from symptoms onset or first diagnosis).	Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Time duration limits of RT-PCR-positivity persistence in different matrices	RT-PCR positivity persistence (days from symptoms onset or first diagnosis)	Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Semi-quantitative OROV RNA viral loads evaluation	Results of OROV RT-PCR testing results by cycle threshold (Ct) values along the study period: RT-PCR (Ct)	Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Quantitative OROV RNA viral load evaluation	Results of OROV RNA copies along the study period: ddPCR (copies/mL)	Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO

Collaborators and Investigators

• Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 24, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 16, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Bunyaviridae Infections
• Other Study ID Numbers: 2024-ZN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No