COVIDIMSEQNCT04368143
COVID-19 Immune Repertoire Sequencing
An observational study of COVID and SARS-CoV 2, run by Institute of Tropical Medicine, Belgium at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, SARS-CoV 2, Corona Virus Infection
- How many people
- 84 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2020to 2 Dec 2021
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- younger than 18 years old
- Ambulatory patients
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Coronavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
provide proof-of-concept that (longitudinal) B cell repertoire mining allows identification of emerging virus specific B cell receptor variable regions.
Measured: 4 months
Secondary outcomes (2)
study evolutions in B and T cell repertoires to understand COVID-19 specific immune responses fundamentally.
Measured: every 7 days during hospitalization a bloodsample is taken
clinical and epidemiological description of UZA hospitalized COVID-19 patients
Measured: at hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start1 Apr 2020
- Primary completion2 Dec 2021
- Study completion2 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368143
- Sponsor's protocol ID
- IMSEQ
- Acronym
- IMSEQ
- Status last verified
- Sep 2023
- First submitted
- 27 Apr 2020
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Immune Repertoire Sequencing
- ClinicalTrials.gov ID
- NCT04368143
- Acronym / sponsor ID
- IMSEQ / IMSEQ
- Conditions
- COVID, SARS-CoV 2, Corona Virus Infection, RDT, B Cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- younger than 18 years old
- Ambulatory patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
provide proof-of-concept that (longitudinal) B cell repertoire mining allows identification of emerging virus specific B cell receptor variable regions.
Time frame: 4 months
2 secondary outcomes
study evolutions in B and T cell repertoires to understand COVID-19 specific immune responses fundamentally.
Time frame: every 7 days during hospitalization a bloodsample is taken
clinical and epidemiological description of UZA hospitalized COVID-19 patients
Time frame: at hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and SARS-CoV 2, run by Institute of Tropical Medicine, Belgium at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
provide proof-of-concept that (longitudinal) B cell repertoire mining allows identification of emerging virus specific B cell receptor variable regions. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.