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COVID-19 Immune Repertoire Sequencing (IMSEQ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368143
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : August 6, 2020
Sponsor:
Collaborator:
University Hospital, Antwerp
Information provided by (Responsible Party):
Institute of Tropical Medicine, Belgium

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).

Condition or disease
COVID SARS-CoV 2 Corona Virus Infection RDT B Cell

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 7 Days
Official Title: COVID-19 Immune Repertoire Sequencing
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. clinical and epidemiological description of UZA hospitalized COVID-19 patients [ Time Frame: at hospitalization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368143


Contacts
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Contact: Koen Vercauteren +32 3 247 63 32 kvercauteren@itg.be

Locations
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Belgium
Universitairy hospital of Antwerp Recruiting
Antwerp, Belgium
Contact: Koen Vercauteren    +32 247 63 32    kvercauteren@itg.be   
Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
University Hospital, Antwerp
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Responsible Party: Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT04368143    
Other Study ID Numbers: IMSEQ
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases