Virological and Immunological Monitoring in Patients (suspected Of/confirmed With) COVID-19
NCT ID: NCT04904692
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
109 participants
OBSERVATIONAL
2020-03-23
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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COVID-19 positive
Peripheral blood draw:
* Day 1 of admission: blood draw.
* Day 7-10 of hospitalization: blood draw.
* Follow-up consultation: blood draw (selected patients).
Bronchoscopic sampling:
Material from bronchoscopic sampling (lavage fluid) will be collected only in those subjects in whom there is a diagnostic or therapeutic need for this procedure.
Swabs for SARS-CoV-2 PCR:
* Day 1 of admission: Extra oropharyngeal, nasal and nasopharyngeal (NP) swabs will be collected after the result of the initial diagnostic swab is known. In case of shortage of swabs, sputum samples will be collected as an alternative.
* Day 7-14 of hospitalization: NP swab or clinically available alternative will be executed on day 7 repeated weekly.
Blood draw
8x9mL EDTA tubes. In subjects treated with hydroxychloroquine treatment an extra EDTA tube (4mL) will be collected for the REVIVE substudy.
Bronchoalveolar lavage
Only in case of diagnostic or therapeutic indication.
SARS CoV-2 swabs
Nasopharyngeal, oropharyngeal and nasal swabs
COVID-19 negative
Peripheral blood draw:
* Day 1 of admission: blood draw.
* Follow-up consultation: blood draw (selected patients).
Bronchoscopic sampling:
Material from bronchoscopic sampling (lavage fluid) will be collected only in those subjects in whom there is a diagnostic or therapeutic need for this procedure.
Swabs for SARS-CoV-2 PCR:
o Day 1 of admission: Extra oropharyngeal, nasal and nasopharyngeal (NP) swabs will be collected after the result of the initial diagnostic swab is known. In case of shortage of swabs, sputum samples will be collected as an alternative.
Blood draw
8x9mL EDTA tubes. In subjects treated with hydroxychloroquine treatment an extra EDTA tube (4mL) will be collected for the REVIVE substudy.
Bronchoalveolar lavage
Only in case of diagnostic or therapeutic indication.
SARS CoV-2 swabs
Nasopharyngeal, oropharyngeal and nasal swabs
Interventions
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Blood draw
8x9mL EDTA tubes. In subjects treated with hydroxychloroquine treatment an extra EDTA tube (4mL) will be collected for the REVIVE substudy.
Bronchoalveolar lavage
Only in case of diagnostic or therapeutic indication.
SARS CoV-2 swabs
Nasopharyngeal, oropharyngeal and nasal swabs
Eligibility Criteria
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Inclusion Criteria
* Requiring hospitalization
Exclusion Criteria
* Inability to give informed consent or absence of legal representative who can give informed consent.
18 Years
ALL
No
Sponsors
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Fund for Scientific Research, Flanders, Belgium
OTHER
Chan Zuckerberg Initiative
OTHER
Flanders Institute for Biotechnology
UNKNOWN
University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Linos Vandekerckhove, Prof. MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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AZ Jan Palfijn
Ghent, Oost-Vlaanderen, Belgium
AZ Maria Middelares
Ghent, Oost-Vlaanderen, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, Belgium
Countries
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Other Identifiers
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BC-07492
Identifier Type: -
Identifier Source: org_study_id
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