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

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ClinicalTrials.gov Identifier: NCT04775134
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.


Condition or disease Intervention/treatment
Covid19 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.

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Residual SARS-CoV-2 Presence in the Respiratory Tract and Lung Parenchyma
Actual Study Start Date : January 31, 2021
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2022

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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Viral culture [ Time Frame: Single time point. ]
    Determining viability of SARS-CoV-2 in case of a low revere transcriptase-PCR cycling threshold


Biospecimen Retention:   Samples With DNA
Lung tissue


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients requiring a medically indicated pulmonary resection.
Criteria

Inclusion Criteria:

  • Patient requires medically indicated pulmonary resection
  • Informed consent

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04775134


Contacts
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Contact: Laurens J Ceulemans, MD, PhD + 32 16 34 34 25 laurens.ceulemans@uzleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Laurens J Ceulemans, MD, PhD    + 32 16 34 34 25    laurens.ceulemans@uzleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Laurens J Ceulemans, MD, PhD UZ Leuven
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04775134    
Other Study ID Numbers: S64988
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No