COVID-19 Immune Repertoire Sequencing

NCT04368143 | Completed

• 1 other identifier: IMSEQ
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This concerns a single-center prospective interventional cohort study. Laboratory-confirmed COVID-19 patients will be asked to donate blood at at least two different timepoints. This will allow us to investigate T and B cell evolutions during the course of infection and recovery. The expected duration of the study is four months or the total duration of the SARS-CoV-2 circulation in Belgium (whichever is shortest).

Conditions

COVID; SARS-CoV 2; Corona Virus Infection; RDT; B Cell

Outcome Measures

Primary Outcomes (1)

• provide proof-of-concept that (longitudinal) B cell repertoire mining allows identification of emerging virus specific B cell receptor variable regions.

  4 months

Secondary Outcomes (2)

• study evolutions in B and T cell repertoires to understand COVID-19 specific immune responses fundamentally.

  every 7 days during hospitalization a bloodsample is taken

• clinical and epidemiological description of UZA hospitalized COVID-19 patients

  at hospitalization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted in an in-patient hospital setting. Patients will be recruited at UZA, where SARS-CoV-2 infected individuals might present. Patients with (mild) respiratory complaints and suspected risk of having contracted SARS-CoV-2 (risk contact with confirmed case, travel history to endemic area) will be tested and isolated in awaiting laboratory SARS-CoV-2 test results. In case of mild respiratory complaints, people will be discharged immediately for home isolation; while patients in need for hospital care will be hospital-admitted (in isolation rooms). If SARS-CoV-2 test results return positive, these hospitalized patients will be asked to participate in this study.

You may qualify if:

• laboratory confirmed COVID-19 acute infection
• be older than 18 years of age
• be hospitalized at the UZA
• willing and able to provide written informed consent by the participant or its legal representative (for instance in case of medical incapacitation)

You may not qualify if:

• younger than 18 years old
• Ambulatory patients

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• University Hospital, Antwerp: collaborator

Study Sites (1)

Universitairy hospital of Antwerp

Antwerp, Belgium

Location

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 29, 2020
• Study Start: April 1, 2020
• Primary Completion: December 2, 2021
• Study Completion: December 2, 2021
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

BE (1)