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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: Lung biopsy

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 Type: Observational
• Enrollment (Anticipated): 75

Contacts and Locations

• Study Contact: Name: Laurens J Ceulemans, MD, PhD; Phone Number: + 32 16 34 34 25; Email: laurens.ceulemans@uzleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Contact: Laurens J Ceulemans, MD, PhD; Phone Number: + 32 16 34 34 25; Email: laurens.ceulemans@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients requiring a medically indicated pulmonary resection.

Description

Inclusion Criteria:

• Patient requires medically indicated pulmonary resection
• Informed consent

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; Patients that require a medically indicated pulmonary resection.	Diagnostic test: Lung biopsy; Biopsy of residuary material from a medically indicated pulmonary resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viral culture	Determining viability of SARS-CoV-2 in case of a low revere transcriptase-PCR cycling threshold	Single time point.

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Laurens J Ceulemans, MD, PhD, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2021
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: S64988

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No