Co-Sér: Serological Analysis and Viral Neutralization in People With a Documented COVID-19 Infection (Coser)
Primary Purpose
SARS-CoV Infection, Immune System Disorder
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Blood sample
Sponsored by
About this trial
This is an interventional basic science trial for SARS-CoV Infection focused on measuring immunology, SARS-CoV2, Antibodies
Eligibility Criteria
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.
Sites / Locations
- Ghent University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Volunteers, infected with COVID-19
Arm Description
Outcomes
Primary Outcome Measures
Neutralising capacity of naturally produced antibodies against SARS-CoV2
Secondary Outcome Measures
Full Information
NCT ID
NCT05000307
First Posted
August 10, 2021
Last Updated
January 9, 2023
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT05000307
Brief Title
Co-Sér: Serological Analysis and Viral Neutralization in People With a Documented COVID-19 Infection
Acronym
Coser
Official Title
Co-Sér: Serological Analysis and Viral Neutralization in People With a Documented COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 28, 2020 (Actual)
Primary Completion Date
January 27, 2021 (Actual)
Study Completion Date
January 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV Infection, Immune System Disorder
Keywords
immunology, SARS-CoV2, Antibodies
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
(serial) blood samples in patients with proven SARS-CoV2
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Volunteers, infected with COVID-19
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood sample
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neutralising capacity of naturally produced antibodies against SARS-CoV2
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linos Vandekerckhove, MD PhD
Organizational Affiliation
PI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Co-Sér: Serological Analysis and Viral Neutralization in People With a Documented COVID-19 Infection
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