Clinical trial NCT04746521: Cellular-Mediated Immunity in COVID-19
Official title: DEtection of Cellular-MEdiated immuniTy in COVID-19 Patients and Subjects Who undeRgone vAccination Program
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Thromboembolism
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

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Brief 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 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:

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.

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:

1. 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-);
2. 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)

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Previous diagnosis of COVID-19
* Absence of COVID-19 diagnosis

Exclusion Criteria:

* Age \<18 years
* Inflammatory diseases

Primary outcomes:
measure: Detection of Cellular-Mediated Immune Response
timeFrame: 3 Months
measure: Detection of Cellular-Mediated Immune Response
timeFrame: 3 Months
Secondary outcomes:
measure: Detection of T cell subpopulation maturation
timeFrame: 5 months
measure: Detection of T cell subpopulation maturation
timeFrame: 5 months
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: 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
Study officials:
References: