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

NCT ID: NCT05557539

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 249 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-07
• Study Completion Date: 2025-06-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

all patients

The intervention consists of taking blood samples, urine sample and naso-pharyngeal sample at two different time points (at inclusion and at week8-12).

Group Type: OTHER

blood samples, urine samples and nasopharyngeal swabs

Intervention Type: BIOLOGICAL

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).

Interventions

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).

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• For all: (1) 18 years or over; (2) Patient or legal representative have provided informed consent.
• Cases: Reverse-transcriptase polymerase chain reaction (RT-PCR) confirmed symptomatic SARS-CoV-2 infection.
• Controls :

1. Patient presenting with acute respiratory failure: (1) Patient presenting with hypoxemic respiratory failure diagnosed by the treating physician and influenza proven as the cause of the respiratory failure; (2) active SARS-CoV-2 infection excluded by RT-PCR and deemed non-probable by the treating physician.

2. Healthy controls : (1) 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.

3. Dexamethasone controls: Patient presenting to the day hospital for an upper or lower limb surgery and who will receive dexamethasone in this context. The criteria for healthy controls also apply.

Exclusion Criteria

• For all: (1) <18 years old ; (2)unwilling to provide informed consent; (3) pregnancy at the time of inclusion
• For cases: Asymptomatic infection
• For controls:

1. Active COVID-19 infection diagnosed by RT-PCR or suspect according to the treating physician at the time of inclusion,

2. For healthy controls: Acute or chronic respiratory failure.

3. Patient currently receiving dexamethasone (i.e. before study inclusion). The criteria for healthy controls also apply.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Cyr Yombi, MD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Countries

Belgium

Other Identifiers

2021/30DEC/543

Identifier Type: -

Identifier Source: org_study_id