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NCT Number: NCT06892015

OBSERVATIONAL STUDY ON VIRAL SHEDDING AND IMMUNOLOGICAL RESPONSE OF OROPOUCHE VIRUS

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Sacro Cuore Don Calabria

Negrar, VR, 37024, Italy

Location status: Recruiting

Location contact

Concetta Castilletti

CONTACT

[email protected]

+39(0)456013111

About this study

This is a study with retrospective and prospective enrollment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Anti-OROV serum antibody response

    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:

    • IgM (titer, reciprocal of dilution);
    • IgG (titer, reciprocal of dilution).
  2. OROV viral RNA shedding in different matrices

    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.

Secondary outcomes

  1. Quality of anti-OROV humoral response

    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).

  2. Quality of anti-OROV cell mediated immunity evolution

    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).

  3. Quality of anti-OROV cytokine production

    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)

  4. Timing evolution of humoral OROV specific response

    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).

  5. Time duration limits of RT-PCR-positivity persistence in different matrices

    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)

  6. Semi-quantitative OROV RNA viral loads evaluation

    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)

  7. Quantitative OROV RNA viral load evaluation

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Elvia Malo

CONTACT

[email protected]

+390456013111

Sponsors and collaborators

Lead sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Other

Registry information

Acronym: OROVIMM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2025
Registry last updated
May 18, 2025

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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