COVID-19 Immune Repertoire Sequencing (IMSEQ)

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).

Study Overview

• Status: Completed
• Conditions: SARS-CoV 2; COVID; Corona Virus Infection; RDT; B Cell

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • Universitairy hospital of Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• younger than 18 years old
• Ambulatory patients

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
provide proof-of-concept that (longitudinal) B cell repertoire mining allows identification of emerging virus specific B cell receptor variable regions.	4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Institute of Tropical Medicine, Belgium
• Collaborators: University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): December 2, 2021
• Study Completion (Actual): December 2, 2021

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Coronavirus Infections
• Other Study ID Numbers: IMSEQ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No