About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient requires medically indicated pulmonary resection
Informed consent
Disqualifiers
Active SARS-CoV-2 infection/COVID-19
No informed consent
Trial population
Patients requiring a medically indicated pulmonary resection.
Trial design
Cohort
Prospective
Treatments tested in this trial
Lung biopsy
Diagnostic testBiopsy of residuary material from a medically indicated pulmonary resection
Treatment groups
Trial outcomes
Primary outcomes
Reverse transcriptase-PCR
Detection of SARS-CoV-2 RNA in lung tissue homogenate with primers targeting both genomic and subgenomic RNA
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
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
Secondary outcomes
Viral culture
Determining viability of SARS-CoV-2 in case of a low revere transcriptase-PCR cycling threshold
Sponsors and contacts
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