SARS CoV-2NCT06914635
Immunotherapy: Care and Prevention of Infectious and Tumoral Diseases (ImmunoHUB)
An observational study of SARS CoV-2 and Liver Tumours, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
The project comprises two research lines. In the line 1, human monoclonal antibodies toward SARS-CoV-2 will be generate and characterized by in vitro functional tests. In the line 2, in vitro tests will be performed to evaluate the efficency of immune response mediated by antibodies direct to specific tumor molecules. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS CoV-2, Liver Tumours
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 30 May 2023to Feb 2027
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Line 1: Recovered subjects from SAS-CoV-2 infection. Line 2: Patients with primary liver tumor
Who may be able to join
- Line 1: - Age >18 at time of signing informed consent form
- Signed informed consent form Line 2: - Primery liver tumor
- Age >18 at time of signing informed consent form
- Signed informed consent form
Who cannot join
- Line 1: - Active or history of neoplastic malignancy
- Active autoimmune disease ongoing treatment with immunosuppressive therapy
- Evidence of positive HIV, HCV, HBV test
- Diabetes
- Failure to sign informed consent form Line 2: - Concomitant diseases with life expectancy of less than 12 months
- Chronic autoimmune or inflammatory diseases
Show all 10Show fewer
- Treatment with atezolizumab, bevacizumab, sorafenib, lenvatinib, regorafenib, cabozantinib, checkpoint inhibitors and tyrosine kinase inhibitors or anti-VEGF therapies
- Other extrahepatic neoplasms occurring or in the last 3 years except for tumors resected with curative intent and without evidence of relapse for >3 years prior to signing informed consent and considered low risk of relapse
- HIV infection
- Failure to sign informed consent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Barbara Oliviero, Biologist contact
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Pavia, 27100
Mario Mondelli, MD, +39 0382 502639, m.mondelli@smatteo.pv.it
Barbara Oliviero, Biologist, b.oliviero@smatteo.pv.it
About this study
The project comprises two research lines. In the line 1, human monoclonal antibodies toward SARS-CoV-2 will be generate and characterized by in vitro functional tests. In the line 2, in vitro tests will be performed to evaluate the efficency of immune response mediated by antibodies direct to specific tumor molecules.
- Conditions
- SARS CoV-2, Liver Tumours
- Medical subject headings
- Carcinoma, Hepatocellular
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 |
|---|---|---|
| Recovered subjects after SARS-CoV-2 infection | Not described | |
| Patients with primary liver tumor. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficiency of antibodies will be evaluated toward SARS-CoV-2 and liver primary tumor cells by functional in vitro tests.
Measured: From enrollement to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start30 May 2023
- Primary completion19 Feb 2025
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV-2Studies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Mondelli, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914635
- Sponsor's protocol ID
- 0047354/23
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 6 Apr 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 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy: Care and Prevention of Infectious and Tumoral Diseases (ImmunoHUB)
- ClinicalTrials.gov ID
- NCT06914635
- Acronym / sponsor ID
- 0047354/23
- Conditions
- SARS CoV-2, Liver Tumours
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 6 Apr 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.
The project comprises two research lines. In the line 1, human monoclonal antibodies toward SARS-CoV-2 will be generate and characterized by in vitro functional tests. In the line 2, in vitro tests will be performed to evaluate the efficency of immune response mediated by antibodies direct to specific tumor molecules.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recovered subjects after SARS-CoV-2 infection | – | – |
| Patients with primary liver tumor. | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Line 1: Recovered subjects from SAS-CoV-2 infection. Line 2: Patients with primary liver tumor
Key inclusion criteria (4 listed)
- Line 1: - Age >18 at time of signing informed consent form
- Signed informed consent form Line 2: - Primery liver tumor
- Age >18 at time of signing informed consent form
- Signed informed consent form
Key exclusion criteria (10 listed)
- Line 1: - Active or history of neoplastic malignancy
- Active autoimmune disease ongoing treatment with immunosuppressive therapy
- Evidence of positive HIV, HCV, HBV test
- Diabetes
- Failure to sign informed consent form Line 2: - Concomitant diseases with life expectancy of less than 12 months
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
The efficiency of antibodies will be evaluated toward SARS-CoV-2 and liver primary tumor cells by functional in vitro tests.
Time frame: From enrollement to 24 weeks
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 6 Apr 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.
Barbara Oliviero, Biologist contact
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 SARS CoV-2 and Liver Tumours, run by Fondazione IRCCS Policlinico San Matteo di Pavia 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 4 inclusion and 10 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 6 Apr 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 Mario Mondelli, MD (+390382502639, m.mondelli@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficiency of antibodies will be evaluated toward SARS-CoV-2 and liver primary tumor cells by functional in vitro tests. (time frame: From enrollement to 24 weeks). 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 6 Apr 2025.