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

Covid19 Clinical Trial

— REASSURE  

Official title:

Residual SARS-CoV-2 Presence in the Respiratory Tract and Lung Parenchyma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04775134
• Other study ID #: S64988
• Status: Recruiting
• Start date: January 31, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Laurens J Ceulemans, MD, PhD
• Phone: + 32 16 34 34 25
• Email: laurens.ceulemans[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2023
• Est. primary completion date: May 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient requires medically indicated pulmonary resection

• Informed consent

Exclusion Criteria:

• Active SARS-CoV-2 infection/COVID-19

• No informed consent

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Diagnostic Test:
• Lung biopsy
Biopsy of residuary material from a medically indicated pulmonary resection

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reverse transcriptase-PCR	Detection of SARS-CoV-2 RNA in lung tissue homogenate with primers targeting both genomic and subgenomic RNA	Single time point.
Primary	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 time point.
Primary	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	Single time point.
Secondary	Viral culture	Determining viability of SARS-CoV-2 in case of a low revere transcriptase-PCR cycling threshold	Single time point.