NCT05557539

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• SARS-CoV-2 Infection
• Influenza Viral Infections

Interventions

Type	Name	Description
BIOLOGICAL	blood samples, urine samples and nasopharyngeal swabs	The following samples will be collected: First time point : 6 blood sample tubes (5mL EDTA, 5mL heparinized and 7.5mL heparinized, 5mL citrate, 5mL serum, 5mL Tempus Blood RNA Tube); 1 urine sample (10mL in a sterile collector) and 1 naso-pharyngeal swab (1mL UT medium). Second time point : 5 blood sample tubes (5mL EDTA,5mL heparinized and 7.5mL heparinized, 5mL serum, 5mL Tempus Blood RNA Tube); 1 urine sample (10mL in a sterile collector) and 1 naso-pharyngeal swab (1mL UT medium).

Timeline

• Start date: 2022-02-07
• Primary completion: 2024-12-18
• Completion: 2025-06-30
• First posted: 2022-09-28
• Last updated: 2025-09-18

Locations

1 site across 1 country: Belgium