An observational study in Covid19, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational
The aim of this study is to confirm or rule out the residual presence and viability of SARS- CoV-2 in the respiratory tract and lung parenchyma of patients previously infected with SARS-CoV-2.
Presence and viability of SARS-CoV-2 in lung tissue will be assessed with reverse transcriptase-polymerase chain reaction (PCR) and viral culture. The histological location of residual SARS-CoV-2 will be determined with fluorescence immunohistochemistry and single molecule fluorescence in situ hybridization, targeting viral proteins and RNA respectively.
The investigators will collect residuary lung tissue after medically indicated pulmonary resections at the Thoracic Surgery Department of University Hospitals Leuven. More specifically the investigators will collect lung tissue from patients that had earlier PCR proven COVID-19 and/or serum anti-SARS-CoV-2 antibodies.
Furthermore, for negative control of the methodology the investigators will also collect lung tissue from patients that have no signs for earlier SARS-CoV-2 infection.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 75 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients requiring a medically indicated pulmonary resection.
Exclusion Criteria:
Patients that require a medically indicated pulmonary resection.
Diagnostic Test: Lung biopsy
Patients that require a medically indicated pulmonary resection.
Diagnostic Test: Lung biopsy
Biopsy of residuary material from a medically indicated pulmonary resection
Reverse transcriptase-PCR
Detection of SARS-CoV-2 RNA in lung tissue homogenate with primers targeting both genomic and subgenomic RNA
Time frame: Single time point.
Fluorescence immunohistochemistry (IHC)
Determining the histological presence of SARS-CoV-2 viral proteins in lung tissue with commercially available antibodies against the SARS-CoV-2 spike and nucleocapsid proteins
Time frame: Single time point.
Single molecule fluorescence in situ hybridization (smFISH)
Determining the presence of SARS-COV-2 viral RNA in lung tissue with commercially available probes targeting both sense and anti-sense viral RNA
Time frame: Single time point.
Viral culture
Determining viability of SARS-CoV-2 in case of a low revere transcriptase-PCR cycling threshold
Time frame: Single time point.
Plan to share: Undecided
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Universitaire Ziekenhuizen KU Leuven