About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial 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.
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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).
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.
Secondary outcomes
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).
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).
Quality of anti-OROV cytokine production
Results of the quality of anti-OROV cytokine production profile along the study period: cytokine analysis (pg/ml)
Timing evolution of humoral OROV specific response
IgM and IgG kinetics (days from symptoms onset or first diagnosis).
Sponsors and contacts
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