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

NCT05000307 | Completed

• 1 other identifier: BC-08071
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV Infection; Immune System Disorder

Keywords

immunology; SARS-CoV2; Antibodies

Outcome Measures

Primary Outcomes (1)

• Neutralising capacity of naturally produced antibodies against SARS-CoV2

  6 months

Study Arms (1)

Volunteers, infected with COVID-19

EXPERIMENTAL

Diagnostic Test: Blood sample

Interventions

Blood sample DIAGNOSTIC_TEST

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.

Volunteers, infected with COVID-19

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Evidence of prior COVID-19 infection, documented by polymerase chain reaction (PCR) or antibody testing (IgG based)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; Immune System Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Linos Vandekerckhove, MD PhD

  PI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: (serial) blood samples in patients with proven SARS-CoV2

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 11, 2021
• Study Start: July 28, 2020
• Primary Completion: January 27, 2021
• Study Completion: January 27, 2021
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)