COVID-19COVIDBioToulNCT04385108
Predictive Immune Biomarkers for COVID-19 Pathogenesis
A study testing Blood collection on admission and longitudinally and Blood collection on their first consultation and 10 to 14 days later in people with COVID-19, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The spectrum of the COVID-19 disease ranges from benign to asymptomatic to viral pneumopathy that can progress to acute respiratory distress syndrome (ARDS). The host-pathogen relationships and the physiopathological mechanisms underlying the clinical aggravation of COVID-19 patients remain misunderstood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Blood collection on admission and longitudinally and Blood collection on their first consultation and 10 to 14 days later
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 565 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2020to 24 Dec 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For COVID-19 hospitalized patients
- Polymerase chain reaction (PCR) proven SARS-CoV-2 infection
- Participation to Toulouse clinical cohort
- Having signed consent for inclusion in the Toulouse biobanks
- For COVID-19 healthcare workers attending dedicated clinics
- PCR proven SARS-CoV-2 infection
- Having signed consent for inclusion in the Toulouse biobanks
Who cannot join
- Pregnancy or breastfeeding
- Participation in another interventional clinical study involving exploratory treatment or blood sampling.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Predictive Immune Biomarkers Based on the Understanding of COVID-19 Pathogenesis to Influence Therapeutic Management
The spectrum of the COVID-19 disease ranges from benign to asymptomatic to viral pneumopathy that can progress to acute respiratory distress syndrome (ARDS). The host-pathogen relationships and the physiopathological mechanisms underlying the clinical aggravation of COVID-19 patients remain misunderstood. The project aim is to create a prospective cohort of biological samples collected from well characterized COVID-19 patients. This project aims first to identify based on these samples an early immune signature predictive of clinical worsening of COVID-19 patients in order to improve their management, and secondarily to better understand pathophysiological mechanisms underlying the different phases of the disease in order to identify innovative therapeutic targets and vaccine perspectives.
Read the detailed description
The World Health Organization (WHO) has recently declared pandemic the coronavirus disease 2019 (COVID-19) due to the causative severe acute respiratory syndrome (SARS) coronavirus (CoV) 2 (SARS-CoV-2). People infected with SARS-CoV-2 vary in severity from being asymptomatic to having severe pneumonia and ARDS. Predictive markers of clinical worsening after admission are lacking. Clinical deterioration often coincides with the development of host antiviral immune responses, suggesting that the inflammatory response to SARS-CoV-2 infection may underpin COVID-19 pathogenesis leading to aberrant and excessive immune responses causing lung functional disability. Relevant therapeutic strategies are still under investigation. Based on a better understanding of COVID-19 immunopathogenesis, the identification of predictive biomarkers early in the disease process would be of outstanding interest to tailor prompt therapeutic interventions.
On this basis, the project aims to create a prospective cohort of biological samples collected from COVID-19 patients followed at the Toulouse University Hospital.
This cohort will collect and cryopreserve biological samples (33 mL), including plasma and peripheral blood mononuclear cells (PBMCs), on admission (day 0) and longitudinally (day 4, 8 12 and in discharge) and will allow us to investigate our primary and secondary objectives. This cohort will be bridged with a clinical cohort in order to have a very well-defined population of COVID-19 patients with the following outcomes:
- Patients with severe disease requiring on admission intensive care unit (ICU) management for ARDS,
- Non-severe hospitalized patients with secondary clinical worsening requiring ICU management,
- Non-severe hospitalized patients without clinical worsening requiring ICU management.
In addition, mildly symptomatic patients among healthcare workers attending outpatient dedicated clinics will be recruited and blood samples will be collected on their first consultation and 10 to 14 days later in the frame of a medical surveillance program.
- Conditions
- COVID-19
- Being tested
- Blood collection on admission and longitudinally, Blood collection on their first consultation and 10 to 14 days later
- Keywords
- SARS-CoV-2, COVID-19, predictive medicine, pathophysiology, immune responses
- 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 collection on admission and longitudinallyBiological
33 mL of blood collected on admission (day 0) and longitudinally (day 4, 8 12 and in discharge)
Blood collection on their first consultation and 10 to 14 days laterBiological
33 mL of blood collected on their first consultation and 10 to 14 days later
| Study group | Role | What they receive |
|---|---|---|
| hospitalized patients | Experimental | very well-defined population of COVID-19 patients with the following outcomes:
* Patients with severe disease requiring on admission ICU management for ARDS,
* Non-severe hospitalized patients with secondary clinical worsening requiring ICU management,
* Non-severe hospitalized patients without clinical worsening requiring ICU management. Receives: Biological: Blood collection on admission and longitudinally |
| healthcare workers | Experimental | mildly symptomatic patients among healthcare workers attending outpatient dedicated clinics will be recruited Receives: Biological: Blood collection on their first consultation and 10 to 14 days later |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune signature
Analysis of the phenotypic profiling of blood T-cells by multicolor fluorescence-activated cell sorter (FACS) analysis assessing T cell subsets through the expression of a wide range of surface and intracellular markers
Measured: Day 0
Dosage of cytokines and chemokines in plasma samples
Analysis on plasma samples of a wide range of cytokines and chemokines using multiplex
Measured: Day 0
Secondary outcomes (11)
Immune signature
Analysis of the phenotypic profiling of blood T-cells by multicolor FACS analysis assessing T cell subsets through the expression of a wide range of surface and intracellular markers
Measured: Day 2
Immune signature
Analysis of the phenotypic profiling of blood T-cells by multicolor FACS analysis assessing T cell subsets through the expression of a wide range of surface and intracellular markers
Measured: Day 4
Immune signature
Analysis of the phenotypic profiling of blood T-cells by multicolor FACS analysis assessing T cell subsets through the expression of a wide range of surface and intracellular markers
Measured: Day 8
Immune signature
Analysis of the phenotypic profiling of blood T-cells by multicolor FACS analysis assessing T cell subsets through the expression of a wide range of surface and intracellular markers
Measured: Day 12
Immune signature
Analysis of the phenotypic profiling of blood T-cells by multicolor FACS analysis assessing T cell subsets through the expression of a wide range of surface and intracellular markers
Measured: Day 30 (or in discharge)
Analysis of the early dynamics of SARS-CoV-2-specific humoral immunity
Measurement of SARS-CoV-2 specific Immunoglobulin M, Immunoglobulin G and Immunoglobulin
Measured: Day 0
Analysis of the early dynamics of SARS-CoV-2-specific humoral immunity
Measurement of SARS-CoV-2 specific Immunoglobulin M, Immunoglobulin G and Immunoglobulin
Measured: Day 2
Analysis of the early dynamics of SARS-CoV-2-specific humoral immunity
Measurement of SARS-CoV-2 specific Immunoglobulin M, Immunoglobulin G and Immunoglobulin
Measured: Day 4
Analysis of the early dynamics of SARS-CoV-2-specific humoral immunity
Measurement of SARS-CoV-2 specific Immunoglobulin M, Immunoglobulin G and Immunoglobulin
Measured: Day 8
Analysis of the early dynamics of SARS-CoV-2-specific humoral immunity
Measurement of SARS-CoV-2 specific Immunoglobulin M, Immunoglobulin G and Immunoglobulin
Measured: Day 12
Analysis of the early dynamics of SARS-CoV-2-specific humoral immunity
Measurement of SARS-CoV-2 specific Immunoglobulin M, Immunoglobulin G and Immunoglobulin
Measured: Day 30 (or in discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start4 Mar 2020
- Primary completion31 Dec 2020
- Study completion24 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 565 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume MARTIN-BLONDEL, MD PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385108
- Sponsor's protocol ID
- RC31/20/0162
- Acronym
- COVIDBioToul
- Status last verified
- Mar 2025
- First submitted
- 5 May 2020
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dimeglio C, Herin F, Da-Silva I, Gernigon C, Porcheron M, Chapuy-Regaud S, Izopet J. Decreased Efficiency of Neutralizing Antibodies from Previously Infected or Vaccinated Individuals against the B.1.617.2 (Delta) SARS-CoV-2 Variant. Microbiol Spectr. 2022 Aug 31;10(4):e0270621. doi: 10.1128/spectrum.02706-21. Epub 2022 Jul 5.
PubMed 35867411Dimeglio C, Herin F, Da-Silva I, Jougla I, Pradere C, Porcheron M, Martin-Blondel G, Chapuy-Regaud S, Izopet J. Heterologous ChAdOx1-S/BNT162b2 Vaccination: Neutralizing Antibody Response to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Clin Infect Dis. 2022 Apr 9;74(7):1315-1316. doi: 10.1093/cid/ciab705. No abstract available.
PubMed 34383902Kreutmair S, Unger S, Nunez NG, Ingelfinger F, Alberti C, De Feo D, Krishnarajah S, Kauffmann M, Friebel E, Babaei S, Gaborit B, Lutz M, Jurado NP, Malek NP, Goepel S, Rosenberger P, Haberle HA, Ayoub I, Al-Hajj S, Nilsson J, Claassen M, Liblau R, Martin-Blondel G, Bitzer M, Roquilly A, Becher B. Distinct immunological signatures discriminate severe COVID-19 from non-SARS-CoV-2-driven critical pneumonia. Immunity. 2021 Jul 13;54(7):1578-1593.e5. doi: 10.1016/j.immuni.2021.05.002. Epub 2021 May 9.
PubMed 34051147
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Predictive Immune Biomarkers Based on the Understanding of COVID-19 Pathogenesis to Influence Therapeutic Management
- ClinicalTrials.gov ID
- NCT04385108
- Acronym / sponsor ID
- COVIDBioToul / RC31/20/0162
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, COVID-19, predictive medicine, pathophysiology, immune responses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 565 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 4 Mar 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 24 Dec 2021 (actual)
- First posted
- 12 May 2020 (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.
The spectrum of the COVID-19 disease ranges from benign to asymptomatic to viral pneumopathy that can progress to acute respiratory distress syndrome (ARDS). The host-pathogen relationships and the physiopathological mechanisms underlying the clinical aggravation of COVID-19 patients remain misunderstood. The project aim is to create a prospective cohort of biological samples collected from well characterized COVID-19 patients. This project aims first to identify based on these samples an early immune signature predictive of clinical worsening of COVID-19 patients in order to improve their management, and secondarily to better understand pathophysiological mechanisms underlying the different phases of the disease in order to identify innovative therapeutic targets and vaccine perspectives.
Detailed description
The World Health Organization (WHO) has recently declared pandemic the coronavirus disease 2019 (COVID-19) due to the causative severe acute respiratory syndrome (SARS) coronavirus (CoV) 2 (SARS-CoV-2). People infected with SARS-CoV-2 vary in severity from being asymptomatic to having severe pneumonia and ARDS. Predictive markers of clinical worsening after admission are lacking. Clinical deterioration often coincides with the development of host antiviral immune responses, suggesting that the inflammatory response to SARS-CoV-2 infection may underpin COVID-19 pathogenesis leading to aberrant and excessive immune responses causing lung functional disability. Relevant therapeutic strategies are still under investigation. Based on a better understanding of COVID-19 immunopathogenesis, the identification of predictive biomarkers early in the disease process would be of outstanding interest to tailor prompt therapeutic interventions.
On this basis, the project aims to create a prospective cohort of biological samples collected from COVID-19 patients followed at the Toulouse University Hospital.
This cohort will collect and cryopreserve biological samples (33 mL), including plasma and peripheral blood mononuclear cells (PBMCs), on admission (day 0) and longitudinally (day 4, 8 12 and in discharge) and will allow us to investigate our primary and secondary objectives. This cohort will be bridged with a clinical cohort in order to have a very well-defined population of COVID-19 patients with the following outcomes:
- Patients with severe disease requiring on admission intensive care unit (ICU) management for ARDS,
- Non-severe hospitalized patients with secondary clinical worsening requiring ICU management,
- Non-severe hospitalized patients without clinical worsening requiring ICU management.
In addition, mildly symptomatic patients among healthcare workers attending outpatient dedicated clinics will be recruited and blood samples will be collected on their first consultation and 10 to 14 days later in the frame of a medical surveillance program.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hospitalized patients | Experimental | Biological: Blood collection on admission and longitudinallyvery well-defined population of COVID-19 patients with the following outcomes: * Patients with severe disease requiring on admission ICU management for ARDS, * Non-severe hospitalized patients with secondary clinical worsening requiring ICU management, * Non-severe hospitalized patients without clinical worsening requiring ICU management. |
| healthcare workers | Experimental | Biological: Blood collection on their first consultation and 10 to 14 days latermildly symptomatic patients among healthcare workers attending outpatient dedicated clinics will be recruited |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- For COVID-19 hospitalized patients
- Polymerase chain reaction (PCR) proven SARS-CoV-2 infection
- Participation to Toulouse clinical cohort
- Having signed consent for inclusion in the Toulouse biobanks
- For COVID-19 healthcare workers attending dedicated clinics
Key exclusion criteria (2 listed)
- Pregnancy or breastfeeding
- Participation in another interventional clinical study involving exploratory treatment or blood sampling.
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 collection on admission and longitudinally33 mL of blood collected on admission (day 0) and longitudinally (day 4, 8 12 and in discharge) | Biological | hospitalized patients |
| Blood collection on their first consultation and 10 to 14 days later33 mL of blood collected on their first consultation and 10 to 14 days later | Biological | healthcare workers |
Primary outcome
Immune signature
Time frame: Day 0
Analysis of the phenotypic profiling of blood T-cells by multicolor fluorescence-activated cell sorter (FACS) analysis assessing T cell subsets through the expression of a wide range of surface and intracellular markers
Dosage of cytokines and chemokines in plasma samples
Time frame: Day 0
Analysis on plasma samples of a wide range of cytokines and chemokines using multiplex
11 secondary outcomes
Immune signature
Time frame: Day 2
Immune signature
Time frame: Day 4
Immune signature
Time frame: Day 8
Immune signature
Time frame: Day 12
Immune signature
Time frame: Day 30 (or in discharge)
Analysis of the early dynamics of SARS-CoV-2-specific humoral immunity
Time frame: Day 0
Analysis of the early dynamics of SARS-CoV-2-specific humoral immunity
Time frame: Day 2
Analysis of the early dynamics of SARS-CoV-2-specific humoral immunity
Time frame: Day 4
Analysis of the early dynamics of SARS-CoV-2-specific humoral immunity
Time frame: Day 8
Analysis of the early dynamics of SARS-CoV-2-specific humoral immunity
Time frame: Day 12
Analysis of the early dynamics of SARS-CoV-2-specific humoral immunity
Time frame: Day 30 (or in discharge)
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 30 Mar 2025.
- Derived from this study: PubMed 35867411Dimeglio C, Herin F, Da-Silva I, Gernigon C, Porcheron M, Chapuy-Regaud S, Izopet J. Decreased Efficiency of Neutralizing Antibodies from Previously Infected or Vaccinated Individuals against the B.1.617.2 (Delta) SARS-CoV-2 Variant. Microbiol Spectr. 2022 Aug 31;10(4):e0270621. doi: 10.1128/spectrum.02706-21. Epub 2022 Jul 5.
- Derived from this study: PubMed 34383902Dimeglio C, Herin F, Da-Silva I, Jougla I, Pradere C, Porcheron M, Martin-Blondel G, Chapuy-Regaud S, Izopet J. Heterologous ChAdOx1-S/BNT162b2 Vaccination: Neutralizing Antibody Response to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Clin Infect Dis. 2022 Apr 9;74(7):1315-1316. doi: 10.1093/cid/ciab705. No abstract available.
- Derived from this study: PubMed 34051147Kreutmair S, Unger S, Nunez NG, Ingelfinger F, Alberti C, De Feo D, Krishnarajah S, Kauffmann M, Friebel E, Babaei S, Gaborit B, Lutz M, Jurado NP, Malek NP, Goepel S, Rosenberger P, Haberle HA, Ayoub I, Al-Hajj S, Nilsson J, Claassen M, Liblau R, Martin-Blondel G, Bitzer M, Roquilly A, Becher B. Distinct immunological signatures discriminate severe COVID-19 from non-SARS-CoV-2-driven critical pneumonia. Immunity. 2021 Jul 13;54(7):1578-1593.e5. doi: 10.1016/j.immuni.2021.05.002. Epub 2021 May 9.
- Individual participant dataSharing planned: No
Related trials for COVID-19
RecruitingPhase 2
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age
SARS-CoV-2
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Recruiting
RSV Burden in Outpatient and Hospital Settings
RSV Infection, Children, Only
Active, not recruitingObservational study
Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)
COVID-19 Vaccination
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.
Guillaume MARTIN-BLONDEL, MD PhD principal investigator
University Hospital, Toulouse
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 collection on admission and longitudinally and Blood collection on their first consultation and 10 to 14 days later in people with COVID-19, run by University Hospital, Toulouse at 1 site in France.
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 7 inclusion and 2 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 30 Mar 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 France. 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?
Immune signature (time frame: Day 0). The study lists 2 primary outcomes in all. 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 NCT04385108, which also lists 3 linked publications.
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 30 Mar 2025.