IRCCS Sacro Cuore Don Calabria
Negrar, VR, 37024, Italy
Location status: Recruiting
NCT Number: NCT06892015
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Negrar, VR, 37024, Italy
Location status: Recruiting
This is a study with retrospective and prospective enrollment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Results of the anti-OROV serum antibody response along the study period:
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
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.
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO.
Results of the anti-OROV neutralizing antibody response along the study period:
neutralizing antibodies titer (titer, reciprocal of dilution).
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Results of the quality of anti-OROV cell mediatedimmune response along the study period: specific cell-mediated response (specific IFN producing cells/100,000).
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO.
Results of the quality of anti-OROV cytokine production profile along the study period: cytokine analysis (pg/ml)
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
IgM and IgG kinetics (days from symptoms onset or first diagnosis).
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
RT-PCR positivity persistence (days from symptoms onset or first diagnosis)
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Results of OROV RT-PCR testing results by cycle threshold (Ct) values along the study period: RT-PCR (Ct)
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Results of OROV RNA copies along the study period: ddPCR (copies/mL)
Contact information is provided by the study sponsor or research team.
IRCCS Sacro Cuore Don Calabria di Negrar
Other
Acronym: OROVIMM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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