Hypothesizing the Genesis of Infectious Diseases and Epidemics Through an Integrated Systems Biology Approach

Last updated: November 27, 2023
Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Overall Status: Active - Recruiting

Phase

N/A

Condition

Covid-19

Corona Virus

Treatment

blood samples, urine samples and nasopharyngeal swabs

Clinical Study ID

NCT05557539
2021/30DEC/543
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

In this study, the investigators aim to collect phenotypical and extensive unbiased multimodal biological data, at two different time points, and to integrate them using a systems biology approach.

The present project aims at generating a systems biology network that can recapitulate the complexity of processes underlying differential SARS-CoV-2 phenotypic responses through exploitation of clinical -omics data. Identifying key determinants and mechanisms of biological variability responsible for phenotypic differences will lead to a better management of patients through the application of precision medicine.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years or over
  • Patient or legal representative have provided informed consent
  • Cases: Reverse-transcriptase polymerase chain reaction (RT-PCR) confirmed symptomaticSARS-CoV-2 infection.
  • Controls : (1) Patient presenting with hypoxemic respiratory failure diagnosed by thetreating physician as being from infectious origin; (2) SARS-CoV-2 infection excludedby RT-PCR and deemed non-probable by the treating physician.
  • Healthy controls : Patients presenting without acute respiratory failure (ie. SpO2 >93%); (2) no RT-PCR or antigen rapid test proven SARS-CoV-2 infection within the last 6 months; (3) no active respiratory tract infection.

Exclusion

Exclusion Criteria:

  • For all: (1) <18 years old ; (2)unwilling to provide informed consent; (3) pregnancyat the time of inclusion
  • For cases: Asymptomatic infection
  • For controls: COVID-19 diagnosed by RT-PCR or suspect according to the treatingphysician at the time of inclusion,
  • For health controls: Acute or chronic respiratory failure.

Study Design

Total Participants: 275
Treatment Group(s): 1
Primary Treatment: blood samples, urine samples and nasopharyngeal swabs
Phase:
Study Start date:
February 07, 2022
Estimated Completion Date:
September 30, 2024

Study Description

HYGIEIA is a multicentric prospective interventional study. The study has two parts, Part 1 with prospective data and sampling, and Part 2 based on samples that were previously collected and stored within COBISA study (2020/11MAI/269).

i. In Part 1, patients acutely infected with SARS-COV-2 will be proposed inclusion. Included patients will be sampled at two different time points (acute infection and convalescent phase, i.e. 8-12 weeks later). Samples will be analysed using cutting edge -omics technologies in order to characterize the genotypic, proteomic, transcriptomic, metabolomic and respiratory microbiota/virome profile through explorative approaches. Clinical and routine biological data will be prospectively collected either as outpatients or during the acute hospitalization and convalescent phase.

ii. In Part 2, samples collected and biobanked during the COBISA study (2020/11MAI/269) will be analysed similarly to the samples collected during the prospective part. Clinical and routine biological data will be retrospectively collected using the patients electronic medical record (EMR).

Generated data will be integrated using a systems biology approach with algorithms developed by a biostatistics team.

Connect with a study center

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200
    Belgium

    Active - Recruiting

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