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Completed

NCT Number: NCT05000307

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Neutralising capacity of naturally produced antibodies against SARS-CoV2

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Acronym: Coser

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 11, 2021
Registry last updated
Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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