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

NCT04775134 | Recruiting

• 1 other identifier: S64988
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (3)

• Reverse transcriptase-PCR

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

  Single time point.

• 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.

• 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 Outcomes (1)

• Viral culture

  Single time point.

Study Arms (2)

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

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

Interventions

Lung biopsy DIAGNOSTIC_TEST

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; Subjects with earlier PCR-proven COVID-19 and/or serum anti-SARS-CoV-2 antibodies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients requiring a medically indicated pulmonary resection.

You may qualify if:

• Patient requires medically indicated pulmonary resection
• Informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Lung tissue

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Laurens J Ceulemans, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurens J Ceulemans, MD, PhD

CONTACT

+ 32 16 34 34 25; laurens.ceulemans@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 1, 2021
• Study Start: January 31, 2021
• Primary Completion: May 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

BE (1)