Co-Sér: Serological Analysis and Viral Neutralization in People With a Documented COVID-19 Infection

Study Overview
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Brief Summary
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In light of the current coronavirus disease 2019 (COVID-19) pandemic, the investigators want to better study the immunological characteristics of Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV2) infections in adults. The investigators invite volunteers to participate in a clinical study to better understand what happens after an infection with SARS-CoV2. By collecting and analysing blood samples of people that were infected, the investigators want to evaluate whether or not the participants had an adaptive immune response with the producting of immunoglobulin. The investigators will evaluate the quality of the antibodies and their neutralising capacity. In a selected patient group with strong antibody response, the investigators will try to reproduce them in the lab after the collection of a larger blood sample (max 72 mL) of, in case of insufficient B-cells, a leucapheresis (after consent of the patient). These antibodies can be used in clinical trials to evaluate whether the investigators can cure patients faster or prevent disease by the utilisation of these antibodies. Aside from the aforementioned information the investigators will also collect clinical data such as: demographic information, medical history, routine lab results, radiographic imaging and medication use. After the completion of the study, the samples will be stored for 30 years with consent of the participants.

Official Title
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Co-Sér: Serological Analysis and Viral Neutralization in People With a Documented COVID-19

Conditions
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SARS-CoV Infection, Immune System Disorder

Intervention / Treatment
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* Diagnostic Test: Blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Evidence of prior COVID-19 infection, documented by polymerase chain reaction (PCR) or antibody testing (IgG based) Exclusion Criteria: Known pregnancy at the time of screening Patient is on immunosuppressive therapy or was treated with immunosuppressive therapy during the last 6 months Inability to give informed consent or absence of legal representative who can give informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: (serial) blood samples in patients with proven SARS-CoV2
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Volunteers, infected with COVID-19<br> | Diagnostic Test: Blood sample<br>* Analysing blood samples for the presence of antibody against SARS-CoV2. When impossible to collect sufficient B-cells for further typing, leucapheresis will be performed if the patient agrees.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutralising capacity of naturally produced antibodies against SARS-CoV2 |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunology, SARS-CoV2, Antibodies