Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04775134
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2021-02-26
Brief Title:
Residual SARS-CoV-2 Presence in the Respiratory Tract and Lung Parenchyma After SARS-CoV-2 Infection or COVID-19
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Residual SARS-CoV-2 Presence in the Respiratory Tract and Lung Parenchyma
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
Recruiting
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REASSURE
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
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 andor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None