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

Not Applicable

Completed

• Conditions: Immune System Disorder; SARS-CoV Infection
• Interventions: Diagnostic Test: Blood sample

• Registration Number: NCT05000307
• Lead Sponsor: University Hospital, Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-28
• Primary Completion: 2021-01-27
• Study Completion: 2021-01-27
• Study First Submitted: 2021-08-10
• Study First Submitted QC: 2021-08-10
• Study First Posted: 2021-08-11
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-09
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Volunteers, infected with COVID-19	Blood sample	-

Primary Outcome Measures

Name	Time	Method
Neutralising capacity of naturally produced antibodies against SARS-CoV2	6 months

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Oost-Vlaanderen, Belgium