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

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Covid19

Treatments: Diagnostic Test: Lung biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT04775134

S64988

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient requires medically indicated pulmonary resection
• Informed consent

Exclusion criteria

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

Trial design

75 participants in 2 patient groups

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

Description:

Patients that require a medically indicated pulmonary resection.

Treatment:

Diagnostic Test: Lung biopsy

Subjects WITHOUT earlier PCR-proven COVID-19 and/or serum anti-SARS-CoV-2 antibodies

Description:

Patients that require a medically indicated pulmonary resection.

Treatment:

Diagnostic Test: Lung biopsy