In-depth Immunological Investigation of COVID-19.
ConditionCoronavirus Infections
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
The COntAGIouS trial (COvid-19 Advanced Genetic and Immunologic Sampling; an in-depth characterization of the dynamic host immune response to coronavirus SARS-CoV-2) proposes a transdisciplinary approach to identify host factors resulting in hyper-susceptibility to SARS-CoV-2 infection, which is urgently needed for directed medical interventions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients >/= 18 years old AND
Hospitalised with PCR-confirmed and/or CT-confirmed SARS-CoV-2 disease
Disqualifiers
Age < 18 years old
No informed consent
Trial population
All patients (\>18 years old) that are admitted to UZ Leuven from March 2020 until September 2026 with PCR-confirmed and/or CT-confirmed SARS-CoV-2 disease are eligible for inclusion.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Patient sampling
Other interventionBlood draw, NP/rectal swab, bronchoscopy if clinically indicated, lung tissue if applicable
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: ICU-hospitalised COVID-19 patients1 intervention
Group B: ward-hospitalised COVID-19 patients1 intervention
Trial outcomes
Primary outcomes
1
Clinical Features
Description of clinical, laboratory and radiological features of illness and complications.
Time frame
6 months2
Immune host response at systemic level
Evaluation of dynamic host immune response at systemic level (immune signalling molecules in plasma, peripheral blood mononuclear cell isolation for advanced immunophenotyping and transcriptomics). Real-time analysis using CyTOF will be performed as screening, in combination with in-depth immunophenotyping.
Time frame
6 months3
Immune host response at local level
Evaluation of dynamic host immune response at systemic level (immune signalling molecules in plasma, peripheral blood mononuclear cell isolation for advanced immunophenotyping and transcriptomics).
Time frame
6 months4
Host genetic variation
Identification of host genetic variants that are associated with severity of disease.
Time frame
6 monthsSecondary outcomes
1
Comparison severe and non-severe COVID-19 hospitalised patients
Differences in baseline factors
Time frame
6 months2
Comparison severe and non-severe COVID-19 hospitalised patients
Differences in immune characteristics
Time frame
6 months3
Correlation of findings with outcome
Correlation of findings with outcome, aiming to identify early biomarkers of severe disease and putative targets for immunomodulatory therapy
Time frame
6 months4
Correlation of immune profiling - microbiome
Correlation of immune profiling with microbiome analysis of patients
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov