Clinical trial NCT06892015: OBSERVATIONAL STUDY ON VIRAL SHEDDING AND IMMUNOLOGICAL RESPONSE OF OROPOUCHE VIRUS
Official title: OBSERVATIONAL STUDY ON VIRAL SHEDDING AND IMMUNOLOGICAL RESPONSE OF OROPOUCHE VIRUS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oropouche Infection
Lead sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

Brief summary: 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.

Detailed description: This is a study with retrospective and prospective enrollment.

Eligibility criteria: 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.

Primary outcomes:
measure: Anti-OROV serum antibody response
timeFrame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
measure: OROV viral RNA shedding in different matrices
timeFrame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Secondary outcomes:
measure: Quality of anti-OROV humoral response
timeFrame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO.
measure: Quality of anti-OROV cell mediated immunity evolution
timeFrame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
measure: Quality of anti-OROV cytokine production
timeFrame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO.
measure: Timing evolution of humoral OROV specific response
timeFrame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
measure: Time duration limits of RT-PCR-positivity persistence in different matrices
timeFrame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
measure: Semi-quantitative OROV RNA viral loads evaluation
timeFrame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
measure: Quantitative OROV RNA viral load evaluation
timeFrame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Other outcomes:
Locations:
city: Negrar
country: Italy
facility: IRCCS Sacro Cuore Don Calabria
state: VR
Study officials:
References: