OBSERVATIONAL STUDY ON VIRAL SHEDDING AND IMMUNOLOGICAL RESPONSE OF OROPOUCHE VIRUS

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Sacro Cuore Don Calabria di Negrar

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

30 Participants
are grouped into 1 trial group
Group A: OROV patients

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
2

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.

Time frame
Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO

Secondary outcomes

1

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).

Time frame
Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO.
2

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).

Time frame
Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
3

Quality of anti-OROV cytokine production

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.
4

Timing evolution of humoral OROV specific response

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

Other outcomes

Sponsors and contacts

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