Residual SARS-CoV-2 Presence in the Respiratory Tract and Lung Parenchyma (After SARS-CoV-2 Infection or COVID-19)

Recruiting

• Conditions: Covid19
• Interventions: Diagnostic Test: Lung biopsy

• Registration Number: NCT04775134
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

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 Timeline

• Study Start: 2021-01-31
• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-05-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Patient requires medically indicated pulmonary resection
• Informed consent

Exclusion Criteria

• Active SARS-CoV-2 infection/COVID-19
• No informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects WITHOUT earlier PCR-proven COVID-19 and/or serum anti-SARS-CoV-2 antibodies	Lung biopsy	Patients that require a medically indicated pulmonary resection.
Subjects with earlier PCR-proven COVID-19 and/or serum anti-SARS-CoV-2 antibodies	Lung biopsy	Patients that require a medically indicated pulmonary resection.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Viral culture	Single time point.	Determining viability of SARS-CoV-2 in case of a low revere transcriptase-PCR cycling threshold

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium