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

SARS-CoV Infection Clinical Trial

— Coser  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05000307
• Other study ID #: BC-08071
• Status: Completed
• Phase: N/A
• Start date: July 28, 2020
• Est. completion date: January 27, 2021

Study information

• Verified date: January 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: January 27, 2021
• Est. primary completion date: January 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immune System Diseases
• Immune System Disorder
• Infections
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Diagnostic Test:
• Blood sample
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.

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neutralising capacity of naturally produced antibodies against SARS-CoV2		6 months