Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04775134
Acronym
REASSURE
Enrollment
75
Registered
2021-03-01
Start date
2021-01-31
Completion date
2025-12-31
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

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.

Interventions

DIAGNOSTIC_TESTLung biopsy

Biopsy of residuary material from a medically indicated pulmonary resection

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Patient requires medically indicated pulmonary resection * Informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Reverse transcriptase-PCRSingle 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

MeasureTime frameDescription
Viral cultureSingle time point.Determining viability of SARS-CoV-2 in case of a low revere transcriptase-PCR cycling threshold

Countries

Belgium

Contacts

Primary ContactLaurens J Ceulemans, MD, PhD
laurens.ceulemans@uzleuven.be+ 32 16 34 34 25

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026