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

Not Applicable

Recruiting

• Conditions: Influenza Viral Infections; SARS-CoV-2 Infection
• Interventions: Biological: blood samples, urine samples and nasopharyngeal swabs

• Registration Number: NCT05557539
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Study Timeline

• Study Start: 2022-02-07
• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-09-27
• Study First Posted: 2022-09-28
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-30
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

• 18 years or over
• 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 hypoxemic respiratory failure diagnosed by the treating physician as being from infectious origin; (2) SARS-CoV-2 infection excluded by 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 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: COVID-19 diagnosed by RT-PCR or suspect according to the treating physician at the time of inclusion,
• For health controls: Acute or chronic respiratory failure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
all patients	blood samples, urine samples and nasopharyngeal swabs	The intervention consists of taking blood samples, urine sample and naso-pharyngeal sample at two different time points (at inclusion and at week8-12).

Primary Outcome Measures

Name	Time	Method
Change on the 11 points World Health Organization (WHO) clinical progression scale	At inclusion (for hospitalized patients daily evaluation untill discharge) and at the end of study visit between 8 and 12 weeks later	Evaluation of disease state on the 11 points WHO Clinical Progression Scale. The minimum value is 0 and corresponds to an uninfected status and the maximum value is 10 in case of death. So a higher score means a worse outcome.

Trial Locations

Locations (1)

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium