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NCT Number: NCT04775134

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient requires medically indicated pulmonary resection
  • Informed consent

Exclusion criteria

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

Treatment and study plan

Lung biopsy

Diagnostic Test

Biopsy of residuary material from a medically indicated pulmonary resection

Primary outcomes

  1. Reverse transcriptase-PCR

    Time frame: Single time point.

    Detection of SARS-CoV-2 RNA in lung tissue homogenate with primers targeting both genomic and subgenomic RNA

  2. Fluorescence immunohistochemistry (IHC)

    Time frame: 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

  3. Single molecule fluorescence in situ hybridization (smFISH)

    Time frame: 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 outcomes

  1. Viral culture

    Time frame: Single time point.

    Determining viability of SARS-CoV-2 in case of a low revere transcriptase-PCR cycling threshold

Study contacts

Contact information is provided by the study sponsor or research team.

Laurens J Ceulemans, MD, PhD

CONTACT

[email protected]

+ 32 16 34 34 25

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: REASSURE

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 1, 2021
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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