Oropouche InfectionOROVIMMNCT06892015
OBSERVATIONAL STUDY ON VIRAL SHEDDING AND IMMUNOLOGICAL RESPONSE OF OROPOUCHE VIRUS
An observational study of Oropouche Infection, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropouche Infection
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 19 Dec 2024to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- lack of signed informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Sacro Cuore Don Calabria
Negrar, VR, 37024
Concetta Castilletti, +39(0)456013111, concetta.castilletti@sacrocuore.it
About this study
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.
Read the detailed description
This is a study with retrospective and prospective enrollment.
- Conditions
- Oropouche Infection
- Medical subject headings
- Bunyaviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OROV patients | 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 DITM. During first clinical encounter, study participants will be interviewed and physically examined as part of routine clinical practice, in this occasion patients will be also approached to obtain informed consent by their attending physician; all the patients will also be asked the consent for the donation of residual samples from routine diagnostic tests to Tropica BioBank. RT-PCR and culture testing will be repeated at each clinical visit and will stop when one negative RT-PCR results from all matrices have been obtained. Immunologic testing will continue for the duration of the study. Subject participation duration will be about 3 months in total. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
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.
Measured: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Secondary outcomes (7)
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).
Measured: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO.
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).
Measured: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Quality of anti-OROV cytokine production
Results of the quality of anti-OROV cytokine production profile along the study period: cytokine analysis (pg/ml)
Measured: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO.
Timing evolution of humoral OROV specific response
IgM and IgG kinetics (days from symptoms onset or first diagnosis).
Measured: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Time duration limits of RT-PCR-positivity persistence in different matrices
RT-PCR positivity persistence (days from symptoms onset or first diagnosis)
Measured: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Semi-quantitative OROV RNA viral loads evaluation
Results of OROV RT-PCR testing results by cycle threshold (Ct) values along the study period: RT-PCR (Ct)
Measured: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Quantitative OROV RNA viral load evaluation
Results of OROV RNA copies along the study period: ddPCR (copies/mL)
Measured: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start19 Dec 2024
- Primary completionApr 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropouche InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892015
- Sponsor's protocol ID
- 2024-ZN
- Acronym
- OROVIMM
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OBSERVATIONAL STUDY ON VIRAL SHEDDING AND IMMUNOLOGICAL RESPONSE OF OROPOUCHE VIRUS
- ClinicalTrials.gov ID
- NCT06892015
- Acronym / sponsor ID
- OROVIMM / 2024-ZN
- Conditions
- Oropouche Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OROV patients | – | –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 DITM. During first clinical encounter, study participants will be interviewed and physically examined as part of routine clinical practice, in this occasion patients will be also approached to obtain informed consent by their attending physician; all the patients will also be asked the consent for the donation of residual samples from routine diagnostic tests to Tropica BioBank. RT-PCR and culture testing will be repeated at each clinical visit and will stop when one negative RT-PCR results from all matrices have been obtained. Immunologic testing will continue for the duration of the study. Subject participation duration will be about 3 months in total. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- lack of signed informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
7 secondary outcomes
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.
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
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.
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
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
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
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 and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropouche Infection, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elvia Malo (+390456013111, ricerca.clinica@sacrocuore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.