REASSURE: Residual SARS-CoV-2 Presence in the Respiratory Tract and Lung Parenchyma (After SARS-CoV-2 Infection or COVID-19)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Subjects with earlier PCR-proven COVID-19 and/or serum anti-SARS-CoV-2 antibodies Patients that require a medically indicated pulmonary resection. |
Diagnostic Test: Lung biopsy
Biopsy of residuary material from a medically indicated pulmonary resection
|
| Subjects WITHOUT earlier PCR-proven COVID-19 and/or serum anti-SARS-CoV-2 antibodies Patients that require a medically indicated pulmonary resection. |
Diagnostic Test: Lung biopsy
Biopsy of residuary material from a medically indicated pulmonary resection
|
Outcome Measures
Primary Outcome Measures
- Reverse transcriptase-PCR [Single time point.]
Detection of SARS-CoV-2 RNA in lung tissue homogenate with primers targeting both genomic and subgenomic RNA
- Fluorescence immunohistochemistry (IHC) [Single time point.]
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) [Single time point.]
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 Outcome Measures
- Viral culture [Single time point.]
Determining viability of SARS-CoV-2 in case of a low revere transcriptase-PCR cycling threshold
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient requires medically indicated pulmonary resection
-
Informed consent
Exclusion Criteria:
-
Active SARS-CoV-2 infection/COVID-19
-
No informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UZ Leuven | Leuven | Belgium | 3000 |
Sponsors and Collaborators
- Universitaire Ziekenhuizen Leuven
Investigators
- Principal Investigator: Laurens J Ceulemans, MD, PhD, UZ Leuven
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- S64988