SARS-CoV-2 InfectionHYGIEIANCT05557539
Hypothesizing the Genesis of Infectious Diseases and Epidemics Through an Integrated Systems Biology Approach
A study testing blood samples, urine samples and nasopharyngeal swabs in people with SARS-CoV-2 Infection and Influenza Viral Infections, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection, Influenza Viral Infections
- What is being tested?
- blood samples, urine samples and nasopharyngeal swabs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Feb 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 :
- 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.
- 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.
- 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.
Who cannot join
- 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:
- Active COVID-19 infection diagnosed by RT-PCR or suspect according to the treating physician at the time of inclusion,
- For healthy controls: Acute or chronic respiratory failure.
- Patient currently receiving dexamethasone (i.e. before study inclusion). The criteria for healthy controls also apply.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- 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
- Being tested
- blood samples, urine samples and nasopharyngeal swabs
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samples, urine samples and nasopharyngeal swabsBiological
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).
| Study group | Role | What they receive |
|---|---|---|
| all patients | Other | The intervention consists of taking blood samples, urine sample and naso-pharyngeal sample at two different time points (at inclusion and at week8-12). Receives: Biological: blood samples, urine samples and nasopharyngeal swabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on the 11 points World Health Organization (WHO) clinical progression scale
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.
Measured: At inclusion (for hospitalized patients daily evaluation untill discharge) and at the end of study visit between 8 and 12 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start7 Feb 2022
- Primary completion18 Dec 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Cyr Yombi, MD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557539
- Sponsor's protocol ID
- 2021/30DEC/543
- Acronym
- HYGIEIA
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2022
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ward B, Bindels LB, Balligand J-L, Bearzatto B, Bommer G, Cani PD, De Greef J, Dewulf JP, Gatto L, Haufroid V, Jodogne S, Kabamba B, Pyr Dit Ruys S, Vertommen D, Yombi JC, Belkhir L, Elens L. Association of nasopharyngeal Dolosigranulum pigrum and Corynebacterium species with post-acute sequelae of SARS-CoV-2 in a longitudinal cohort. Microbiol Spectr. 2026 Apr 7;14(4):e0231325. doi: 10.1128/spectrum.02313-25. Epub 2026 Mar 17.
PubMed 41841761
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypothesizing the Genesis of Infectious Diseases and Epidemics Through an Integrated Systems Biology Approach
- ClinicalTrials.gov ID
- NCT05557539
- Acronym / sponsor ID
- HYGIEIA / 2021/30DEC/543
- Conditions
- SARS-CoV-2 Infection, Influenza Viral Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all patients | Other | Biological: blood samples, urine samples and nasopharyngeal swabsThe intervention consists of taking blood samples, urine sample and naso-pharyngeal sample at two different time points (at inclusion and at week8-12). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 :
Key exclusion criteria (6 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samples, urine samples and nasopharyngeal swabsThe 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). | Biological | all patients |
Primary outcome
Change on the 11 points World Health Organization (WHO) clinical progression scale
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Derived from this study: PubMed 41841761Ward B, Bindels LB, Balligand J-L, Bearzatto B, Bommer G, Cani PD, De Greef J, Dewulf JP, Gatto L, Haufroid V, Jodogne S, Kabamba B, Pyr Dit Ruys S, Vertommen D, Yombi JC, Belkhir L, Elens L. Association of nasopharyngeal Dolosigranulum pigrum and Corynebacterium species with post-acute sequelae of SARS-CoV-2 in a longitudinal cohort. Microbiol Spectr. 2026 Apr 7;14(4):e0231325. doi: 10.1128/spectrum.02313-25. Epub 2026 Mar 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Cyr Yombi, MD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples, urine samples and nasopharyngeal swabs in people with SARS-CoV-2 Infection and Influenza Viral Infections, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on the 11 points World Health Organization (WHO) clinical progression scale (time frame: At inclusion (for hospitalized patients daily evaluation untill discharge) and at the end of study visit between 8 and 12 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05557539, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.