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

ConditionCovid19
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient requires medically indicated pulmonary resection

Informed consent

Disqualifiers

Active SARS-CoV-2 infection/COVID-19

No informed consent

Trial population

Patients requiring a medically indicated pulmonary resection.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Lung biopsy

    Diagnostic test

    Biopsy of residuary material from a medically indicated pulmonary resection

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: Subjects with earlier PCR-proven COVID-19 and/or serum anti-SARS-CoV-2 antibodies1 intervention
Group B: Subjects WITHOUT earlier PCR-proven COVID-19 and/or serum anti-SARS-CoV-2 antibodies1 intervention

Trial outcomes

Primary outcomes

1

Reverse transcriptase-PCR

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

Time frame
Single time point.
2

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

Time frame
Single time point.
3

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

Time frame
Single time point.

Secondary outcomes

1

Viral culture

Determining viability of SARS-CoV-2 in case of a low revere transcriptase-PCR cycling threshold

Time frame
Single time point.

Other outcomes

Sponsors and contacts

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