Covid19DEMETRANCT04746521
Cellular-Mediated Immunity in COVID-19
An observational study of Covid19 and Thromboembolism, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
In order to prevent reinfection, it is needed to detect the cellular-mediated immune response to the Sars-CoV-2 infection. The first goal of this study will be to detect the cellular-mediated immune response in patients affected by COVID-19 (with or without vaccination) and healthy subjects who undergone vaccination… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Thromboembolism
- What is being tested?
- Multitest 6 color TBNK and BD Lyotubes and genomicDNA extraction
- Type of treatment
- Vaccines
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 14 Mar 2021to 14 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cases: Patients with previous diagnosed Sars-CoV-2 infection who did undergo vaccination. Patients with previous diagnosed Sars-CoV-2 infection who did not undergo vaccination. Subjects without diagnosed Sars-CoV-2 infection who adhered to vaccination program. -
Who may be able to join
- Age > 18 years
- Previous diagnosis of COVID-19
- Absence of COVID-19 diagnosis
Who cannot join
- Age <18 years
- Inflammatory diseases
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
U.O.C. Division of Clinical Immunology, Immunohematology, Transfusion Medicine and Transplant Immunology, Regional Reference Laboratory of Transplant Immunology, Department of Internal and Specialty Medicine, A.O.U., UniversityofCampania "Luigi Vanvitelli
Naples, 80138
Giuditta Benincasa, BiolD, MSc, giuditta.benincasa@unicampania.it
About this study
Official title: DEtection of Cellular-MEdiated immuniTy in COVID-19 Patients and Subjects Who undeRgone vAccination Program
In order to prevent reinfection, it is needed to detect the cellular-mediated immune response to the Sars-CoV-2 infection. The first goal of this study will be to detect the cellular-mediated immune response in patients affected by COVID-19 (with or without vaccination) and healthy subjects who undergone vaccination program. The second goal of this study will be to identify the genetic and epigenetic biomarkers that influence individual immunological response and clinical evolution to the severe manifestations of the COVID-19.
Read the detailed description
First goal: Characterization of the immune response using detailed phenotypic evaluation of the adaptive compartment comprising B, T, and NK cells. The Investigators aim is to detect the cellular-mediated immune response in patients affected by COVID-19 and subjects who undergone vaccination program.
The Investigators will recruit three classes of subjects:
- Patients with previous Sars-CoV-2 infection who did not undergo vaccination;
- Patients with previous Sars-CoV-2 infection who undergone vaccination;
- Subjects without previous Sars-CoV-2 infection who undergone vaccination.
Second goal: Evaluation of genetic and epigenetic biomarkers that influence individual immunological response and susceptibility to thromboembolic manifestations in severe COVID-19 hospitalized patients.
The Investigators will recruit:
- A total of 50 severe COVID-19 patients admitted to the Sub-Intensive Care Unit of A.O.R.N. Ospedali dei Colli, Cotugno Hospital, Naples (Italy) of which N=50 with thromboembolic complications (PE+) and N=50 without thromboembolic complications (PE-);
- A total of N=50 healthy subjects (never diagnosed with Sars-Cov2 infection) among the volunteer blood donors attending the U.O.C. Divisione di Immunologia Clinica, Immunoematologia, Medicina Trasfusionale e Immunologia dei Trapianti, Dipartimento di Medicina Interna e Specialistica, AOU, "L. Vanvitelli" University of Campania (Naples, Italy)
- Conditions
- Covid19, Thromboembolism
- Being tested
- Multitest 6 color TBNK and BD Lyotubes, genomicDNA extraction
- Medical subject headings
- COVID-19, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multitest 6 color TBNK and BD LyotubesDiagnostic test
The Multitest 6 color TBNK allows us to count the population-specific B, T, NK cells
genomicDNA extractionBiological
Peripheral blood biospecimens (about 10-15 mL) will be collected through venipuncture in EDTA tubes. Peripheral blood mononuclear cells (PBMCs) will be isolated using Ficoll® Paque Plus (Sigma-Aldrich) centrifugation gradient and genomic DNA will be extracted from fresh PBMCs using DNeasy Blood \& Tissue kit (QIAGEN), according to manufacturer protocols
| Study group | Role | What they receive |
|---|---|---|
| Severe COVID-19 hospitalized patients | A total of 50 severe COVID-19 patients admitted to the Sub-Intensive Care Unit of A.O.R.N. Ospedali dei Colli, Cotugno Hospital, Naples (Italy) will be recruited, of which N=50 with thromboembolic complications (PE+) and N=50 without thromboembolic complications (PE-) balanced for age and sex of individuals. Receives: Biological: genomicDNA extraction | |
| Healthy controls (comparator group) | As control group (CTRL), we will recruit a total of N=50 healthy subjects (never diagnosed with Sars-Cov2 infection) among the volunteer blood donors attending the U.O.C. Divisione di Immunologia Clinica, Immunoematologia, Medicina Trasfusionale e Immunologia dei Trapianti, Dipartimento di Medicina Interna e Specialistica, AOU, "L. Vanvitelli" University of Campania (Naples, Italy). Receives: Biological: genomicDNA extraction | |
| COVID-19 patients compared with vaccinated subjects | 1. Patients with previous Sars-CoV-2 infection who did not undergo vaccination;
2. Patients with previous Sars-CoV-2 infection who undergone vaccination
3. Subjects without previous Sars-CoV-2 infection who undergone vaccination Receives: Diagnostic Test: Multitest 6 color TBNK and BD Lyotubes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Cellular-Mediated Immune Response
The Investigators will perform the BD Multitest 6-color TBNK by using 50 uL of peripheral blood to detect the absolute number (N) of CD3+, CD19+, CD16+, CD46+, CD4+ and CD8+ cells.
Measured: 3 Months
Detection of Cellular-Mediated Immune Response
The Investigators will perform the BD™ Lyotubes kit by using 150 uL of peripheral blood to detect the absolute number (N) of CD4+ and CD8+ cells undergoing to differentiation from naive T cells to central memory, effector memory, and terminal memory
Measured: 3 Months
Secondary outcomes (2)
Detection of T cell subpopulation maturation
The Investigators will perform the BD™ Lyotubes kit by using 150 uL of peripheral blood to detect the absolute number (N) of CD4+ and CD8+ cells undergoing to differentiation from naive T cells to central memory, effector memory, and terminal memory.
Measured: 5 months
Detection of T cell subpopulation maturation
The Investigators will perform the BD™ Lyotubes kit by using 150 uL of peripheral blood to detect the % of CD4+ and CD8+ cells undergoing to differentiation from naive T cells to central memory, effector memory, and terminal memory.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start14 Mar 2021
- Primary completion14 Jan 2022
- Study completion14 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuditta Benincasa, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746521
- Sponsor's protocol ID
- L. Vanvitelli
- Acronym
- DEMETRA
- Status last verified
- Jan 2022
- First submitted
- 8 Feb 2021
- Last updated
- 14 Feb 2022
- 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 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEtection of Cellular-MEdiated immuniTy in COVID-19 Patients and Subjects Who undeRgone vAccination Program
- ClinicalTrials.gov ID
- NCT04746521
- Acronym / sponsor ID
- DEMETRA / L. Vanvitelli
- Conditions
- Covid19, Thromboembolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 14 Mar 2021 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 14 Dec 2022 (estimated)
- First posted
- 9 Feb 2021 (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 order to prevent reinfection, it is needed to detect the cellular-mediated immune response to the Sars-CoV-2 infection. The first goal of this study will be to detect the cellular-mediated immune response in patients affected by COVID-19 (with or without vaccination) and healthy subjects who undergone vaccination program. The second goal of this study will be to identify the genetic and epigenetic biomarkers that influence individual immunological response and clinical evolution to the severe manifestations of the COVID-19.
Detailed description
First goal: Characterization of the immune response using detailed phenotypic evaluation of the adaptive compartment comprising B, T, and NK cells. The Investigators aim is to detect the cellular-mediated immune response in patients affected by COVID-19 and subjects who undergone vaccination program.
The Investigators will recruit three classes of subjects:
- Patients with previous Sars-CoV-2 infection who did not undergo vaccination;
- Patients with previous Sars-CoV-2 infection who undergone vaccination;
- Subjects without previous Sars-CoV-2 infection who undergone vaccination.
Second goal: Evaluation of genetic and epigenetic biomarkers that influence individual immunological response and susceptibility to thromboembolic manifestations in severe COVID-19 hospitalized patients.
The Investigators will recruit:
- A total of 50 severe COVID-19 patients admitted to the Sub-Intensive Care Unit of A.O.R.N. Ospedali dei Colli, Cotugno Hospital, Naples (Italy) of which N=50 with thromboembolic complications (PE+) and N=50 without thromboembolic complications (PE-);
- A total of N=50 healthy subjects (never diagnosed with Sars-Cov2 infection) among the volunteer blood donors attending the U.O.C. Divisione di Immunologia Clinica, Immunoematologia, Medicina Trasfusionale e Immunologia dei Trapianti, Dipartimento di Medicina Interna e Specialistica, AOU, "L. Vanvitelli" University of Campania (Naples, Italy)
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Severe COVID-19 hospitalized patients | – | Biological: genomicDNA extractionA total of 50 severe COVID-19 patients admitted to the Sub-Intensive Care Unit of A.O.R.N. Ospedali dei Colli, Cotugno Hospital, Naples (Italy) will be recruited, of which N=50 with thromboembolic complications (PE+) and N=50 without thromboembolic complications (PE-) balanced for age and sex of individuals. |
| Healthy controls (comparator group) | – | Biological: genomicDNA extractionAs control group (CTRL), we will recruit a total of N=50 healthy subjects (never diagnosed with Sars-Cov2 infection) among the volunteer blood donors attending the U.O.C. Divisione di Immunologia Clinica, Immunoematologia, Medicina Trasfusionale e Immunologia dei Trapianti, Dipartimento di Medicina Interna e Specialistica, AOU, "L. Vanvitelli" University of Campania (Naples, Italy). |
| COVID-19 patients compared with vaccinated subjects | – | Diagnostic Test: Multitest 6 color TBNK and BD Lyotubes1. Patients with previous Sars-CoV-2 infection who did not undergo vaccination; 2. Patients with previous Sars-CoV-2 infection who undergone vaccination 3. Subjects without previous Sars-CoV-2 infection who undergone vaccination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cases: Patients with previous diagnosed Sars-CoV-2 infection who did undergo vaccination. Patients with previous diagnosed Sars-CoV-2 infection who did not undergo vaccination. Subjects without diagnosed Sars-CoV-2 infection who adhered to vaccination program. -
Key inclusion criteria (3 listed)
- Age > 18 years
- Previous diagnosis of COVID-19
- Absence of COVID-19 diagnosis
Key exclusion criteria (2 listed)
- Age <18 years
- Inflammatory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multitest 6 color TBNK and BD LyotubesThe Multitest 6 color TBNK allows us to count the population-specific B, T, NK cells | Diagnostic test | COVID-19 patients compared with vaccinated subjects |
| genomicDNA extractionPeripheral blood biospecimens (about 10-15 mL) will be collected through venipuncture in EDTA tubes. Peripheral blood mononuclear cells (PBMCs) will be isolated using Ficoll® Paque Plus (Sigma-Aldrich) centrifugation gradient and genomic DNA will be extracted from fresh PBMCs using DNeasy Blood \& Tissue kit (QIAGEN), according to manufacturer protocols | Biological | Healthy controls (comparator group), Severe COVID-19 hospitalized patients |
Primary outcome
Detection of Cellular-Mediated Immune Response
Time frame: 3 Months
The Investigators will perform the BD Multitest 6-color TBNK by using 50 uL of peripheral blood to detect the absolute number (N) of CD3+, CD19+, CD16+, CD46+, CD4+ and CD8+ cells.
Detection of Cellular-Mediated Immune Response
Time frame: 3 Months
The Investigators will perform the BD™ Lyotubes kit by using 150 uL of peripheral blood to detect the absolute number (N) of CD4+ and CD8+ cells undergoing to differentiation from naive T cells to central memory, effector memory, and terminal memory
2 secondary outcomes
Detection of T cell subpopulation maturation
Time frame: 5 months
Detection of T cell subpopulation maturation
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
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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.
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 Covid19 and Thromboembolism, run by University of Campania Luigi Vanvitelli 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 2 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: status not confirmed, as of the sponsor's last update on 14 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuditta Benincasa, BiolD. MSc (+39 0815667916, giuditta.benincasa@unicampania.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Cellular-Mediated Immune Response (time frame: 3 Months). 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 14 Feb 2022.