COVID 19NCT06891170
B Cell Responses in COVID-19
An observational study of COVID 19, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
In this study, we will develop techniques to optimize the in vitro production of human monoclonal antibodies. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID 19
- How many people
- 4 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jul 2021to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Vaccinated or recovered subjects from COVID-19
Who may be able to join
- Age >18 at time of signing informed consent form
- Signed informed consent form
Who cannot join
- Ongoing drug abuse
- Active or history of neoplastic malignancy
- Active autoimmune disease ongoing treatment with immunosuppressive therapy
- Ischemic heart disease
- Evidence of positive HIV, HCV, HBV test
- Diabetes
- Failure to sign informed consent form
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Pavia, 27100
About this study
Official title: B Cell Responses in COVID-19: Generation of SARS-CoV-2 Neutralizing Human Monoclonal Antibodies to Efficiently Contrast Wild-type and Emerging Variants.
In this study, we will develop techniques to optimize the in vitro production of human monoclonal antibodies.
- Conditions
- COVID 19
- Medical subject headings
- COVID-19
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 |
|---|---|---|
| Vaccinated or recovered subjects from COVID-19 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimization of the method to obtain human mAbs neutralizing COVID-19.
Measured: From enrollment 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 posted24 Mar 2025
- Study start7 Jul 2021
- Primary completion14 Oct 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID 19Studies 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Oliviero, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891170
- Sponsor's protocol ID
- RC_08072721
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 30 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 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B Cell Responses in COVID-19: Generation of SARS-CoV-2 Neutralizing Human Monoclonal Antibodies to Efficiently Contrast Wild-type and Emerging Variants.
- ClinicalTrials.gov ID
- NCT06891170
- Acronym / sponsor ID
- RC_08072721
- Conditions
- COVID 19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 14 Oct 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- 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.
In this study, we will develop techniques to optimize the in vitro production of human monoclonal antibodies.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccinated or recovered subjects from COVID-19 | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Vaccinated or recovered subjects from COVID-19
Key inclusion criteria (2 listed)
- Age >18 at time of signing informed consent form
- Signed informed consent form
Key exclusion criteria (7 listed)
- Ongoing drug abuse
- Active or history of neoplastic malignancy
- Active autoimmune disease ongoing treatment with immunosuppressive therapy
- Ischemic heart disease
- Evidence of positive HIV, HCV, HBV test
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
Optimization of the method to obtain human mAbs neutralizing COVID-19.
Time frame: From enrollment to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID 19, 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 30 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimization of the method to obtain human mAbs neutralizing COVID-19. (time frame: From enrollment 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 30 Apr 2025.