COVID-19IMMUNOMARKCOVNCT04668170
Predictive Immune Biomarkers of COVID-19 Pathogenesis to Influence Therapeutic Management
An observational study of COVID-19, run by University Hospital, Toulouse at 2 sites in France.
Trial summary
Persons infected with Severe Acute Respiratory Syndrome (SARS) SARS-CoV-2 vary in severity from being asymptomatic to having fever, cough, sore throat, general weakness and fatigue and muscular pain and in the most severe cases, severe pneumonia, acute respiratory distress syndrome and sepsis potentially leading to… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- 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
- How many people
- 304 participants
- Where
- 2 sitesFrance
- Study dates
- 5 May 2020to 2 May 2023
- Phase
- Observational
- 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized or healthy workers for COVID-19
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
2 sites in 1 country.
France2 sites
University Hospital Bordeaux
Bordeau, 33000
University Hospital Toulouse
Toulouse, 31059
About this study
Official title: Identification of Predictive Immune Biomarkers Based on the Understanding of COVID-19 Pathogenesis to Influence Therapeutic Management
Persons infected with Severe Acute Respiratory Syndrome (SARS) SARS-CoV-2 vary in severity from being asymptomatic to having fever, cough, sore throat, general weakness and fatigue and muscular pain and in the most severe cases, severe pneumonia, acute respiratory distress syndrome and sepsis potentially leading to death. Predictive markers of clinical worsening after admission are lacking. COVID-19 immunopathogenesis and relevant therapeutic strategies are still under investigation.
Although viral shedding peaks during the first week of symptoms, reports show that clinical deterioration often coincides with the development of host antiviral immune responses. The inflammatory response to SARS-CoV-2 infection may underpin COVID-19 pathogenesis leading to aberrant and excessive immune responses that may enter the pulmonary circulation in large numbers and play an immune damaging role causing lung functional disability resulting in clinical worsening. Therapeutic strategies using corticosteroids or biotherapies targeting IL-6 may be valuable in some patients. 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 these bases, the present project aims to unravel, using innovative integrated multimodal immunological approaches, immunologic predictive markers by finely characterizing from their admission innate and adaptive immune responses in two well described cohorts of COVID-19 patients that are being collected in Toulouse (COVID-BioToul) and Bordeaux (COLCOV-19 BX).Those two biological cohorts are connected with two clinical cohorts in Toulouse and Bordeaux in order to have a very well defined population of COVID-19 patients and their clinical outcome. In both cohorts, investigators harvest and cryopreserve biological samples, including plasma and peripheral blood mononuclear cells (PBMCs), on admission and longitudinally from patients evolving or not toward severe forms of the disease in Bordeaux and Toulouse University Hospitals and will allow to investigate primary and secondary objectives. Moreover in the two centers, there are also two clinical outpatients cohorts of healthcare workers attending dedicated clinics in the frame of their surveillance medical program, which constitute groups of patients with benign forms of COVID-19.
Read the detailed description
The primary objective of IMMUNOMARK-COV is to define an applicable immune signature predicting clinical worsening on COVID-19 patient admission in order to help physicians to take informed therapeutic decisions able to modify early the course of the disease.
Secondary objectives are:
- To assess the early dynamics of SARS-CoV-2-specific cellular immunity in patients followed longitudinally
- To assess the dynamics of gd T cells during COVID-19
- Transcriptomic analysis of discrete and functionally major T cell populations
- To assess SARS-CoV-2-specific humoral immunity in patients upon recovery
Identification of early predictive biomarkers of worsening of COVID-19 patients is of paramount importance. This goal is expected to be achieved through the fine analysis of circulating immune effectors, and their dynamics, in categories of patients with very different clinical outcomes.
To date, management of clinical worsening relies mainly on supportive care in ICU, leading to prolonged stay and saturation of facilities. Earlier therapeutic intervention based on identification of robust predictive biomarkers should:
- Help physicians to take therapeutic decisions
- Improve prognosis of patients that suffered from clinical worsening
- Prevent clinical worsening and transfer to ICU
- Improve the burden relying on ICU facilities in a setting of overflow
- Improve the prevention and management of COVID-19 patients to be able to face in a near future several other waves of COVID-19 Furthermore, identification of immune effectors implicated in tissular damages may also help to identify new therapeutic targets.
- 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, 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
Samples already 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
Samples already collected on consultation (D0) and 14 days later
| Study group | Role | What they receive |
|---|---|---|
| hospitalized patients | very well-defined population of COVID-19 patients with the following outcomes:
Patients with severe disease requiring on admission ICU management for SARS, 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 | 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 on admission : phenotypic profile of blood T-cells
Immune signature will be compared between COVID-19 patients according to their clinical characteristics and outcome, together with SARS-CoV2 viral shedding (known for every patient in the cohort) on samples harvested on admission: a phenotypic profiling of blood T-cells by multicolor FACS analysis (using 30+ color panels analyzed by multiparametric flow cytometry) assessing T cell subsets (classical CD4 or CD8 T-cells as well as unconventional gdT-cells and regulatory T cells) through the expression of a wide range of surface and intracellular markers.
Measured: Day 0
Immune signature on admission : inflammatory cytokines
Immune signature will be compared between COVID-19 patients according to their clinical characteristics and outcome, together with SARS-CoV2 viral shedding (known for every patient in the cohort) on samples harvested on admission: An analysis on plasma samples of concentration of a wide range of inflammatory cytokines such as IFNa, IFNb and IL-6.
Measured: Day 0
Secondary outcomes (4)
Dynamics of cellular immunity: CD4 and CD8 T cells
On samples harvested longitudinally from patients, analysis of the relative magnitude and dynamic and polyfunctional profile of SARS-CoV-2 specific CD8 and CD4 T cell responses by analyzing the capacity of T cells to produce simultaneously a variety of cytokines such as IFNa, IFNb and IL-6, will be performed.
Measured: Day 0, Day 4, Day 8, Day 12, Day 30 (or in discharge)
Dynamics of cellular immunity: gd T cells
On samples harvested longitudinally from patients, dynamics of gd T cells will be performed.
Measured: Day 0, Day 4, Day 8, Day 12, Day 30 (or in discharge)
Dynamics of cellular immunity: T cell transcriptomic analysis
On samples harvested longitudinally from patients, transcriptomic analysis of different types of T cells will be performed.
Measured: Day 0, Day 4, Day 8, Day 12, Day 30 (or in discharge)
Dynamics of cellular immunity: humoral immunity
On samples harvested longitudinally from patients, humoral immunity will be performed.
Measured: Day 0, Day 4, Day 8, Day 12, 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 posted16 Dec 2020
- Study start5 May 2020
- Primary completion31 Dec 2021
- Study completion2 May 2023
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 COVID-19Studies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre DELOBEL, MD PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668170
- Sponsor's protocol ID
- RC31/20/0187
- Acronym
- IMMUNOMARKCOV
- Status last verified
- Mar 2026
- First submitted
- 12 Nov 2020
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kreutmair 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 20 Mar 2026. 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
- NCT04668170
- Acronym / sponsor ID
- IMMUNOMARKCOV / RC31/20/0187
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, predictive medicine, pathophysiology, immune responses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 5 May 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 16 Dec 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.
Persons infected with Severe Acute Respiratory Syndrome (SARS) SARS-CoV-2 vary in severity from being asymptomatic to having fever, cough, sore throat, general weakness and fatigue and muscular pain and in the most severe cases, severe pneumonia, acute respiratory distress syndrome and sepsis potentially leading to death. Predictive markers of clinical worsening after admission are lacking. COVID-19 immunopathogenesis and relevant therapeutic strategies are still under investigation.
Although viral shedding peaks during the first week of symptoms, reports show that clinical deterioration often coincides with the development of host antiviral immune responses. The inflammatory response to SARS-CoV-2 infection may underpin COVID-19 pathogenesis leading to aberrant and excessive immune responses that may enter the pulmonary circulation in large numbers and play an immune damaging role causing lung functional disability resulting in clinical worsening. Therapeutic strategies using corticosteroids or biotherapies targeting IL-6 may be valuable in some patients. 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 these bases, the present project aims to unravel, using innovative integrated multimodal immunological approaches, immunologic predictive markers by finely characterizing from their admission innate and adaptive immune responses in two well described cohorts of COVID-19 patients that are being collected in Toulouse (COVID-BioToul) and Bordeaux (COLCOV-19 BX).Those two biological cohorts are connected with two clinical cohorts in Toulouse and Bordeaux in order to have a very well defined population of COVID-19 patients and their clinical outcome. In both cohorts, investigators harvest and cryopreserve biological samples, including plasma and peripheral blood mononuclear cells (PBMCs), on admission and longitudinally from patients evolving or not toward severe forms of the disease in Bordeaux and Toulouse University Hospitals and will allow to investigate primary and secondary objectives. Moreover in the two centers, there are also two clinical outpatients cohorts of healthcare workers attending dedicated clinics in the frame of their surveillance medical program, which constitute groups of patients with benign forms of COVID-19.
Detailed description
The primary objective of IMMUNOMARK-COV is to define an applicable immune signature predicting clinical worsening on COVID-19 patient admission in order to help physicians to take informed therapeutic decisions able to modify early the course of the disease.
Secondary objectives are:
- To assess the early dynamics of SARS-CoV-2-specific cellular immunity in patients followed longitudinally
- To assess the dynamics of gd T cells during COVID-19
- Transcriptomic analysis of discrete and functionally major T cell populations
- To assess SARS-CoV-2-specific humoral immunity in patients upon recovery
Identification of early predictive biomarkers of worsening of COVID-19 patients is of paramount importance. This goal is expected to be achieved through the fine analysis of circulating immune effectors, and their dynamics, in categories of patients with very different clinical outcomes.
To date, management of clinical worsening relies mainly on supportive care in ICU, leading to prolonged stay and saturation of facilities. Earlier therapeutic intervention based on identification of robust predictive biomarkers should:
- Help physicians to take therapeutic decisions
- Improve prognosis of patients that suffered from clinical worsening
- Prevent clinical worsening and transfer to ICU
- Improve the burden relying on ICU facilities in a setting of overflow
- Improve the prevention and management of COVID-19 patients to be able to face in a near future several other waves of COVID-19 Furthermore, identification of immune effectors implicated in tissular damages may also help to identify new therapeutic targets.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hospitalized patients | – | 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 SARS, Non-severe hospitalized patients with secondary clinical worsening requiring ICU management, Non-severe hospitalized patients without clinical worsening requiring ICU management. |
| healthcare workers | – | 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 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized or healthy workers for COVID-19
Key inclusion criteria (6 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
- PCR proven SARS-CoV-2 infection
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 longitudinallySamples already 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 laterSamples already collected on consultation (D0) and 14 days later | Biological | healthcare workers |
Primary outcome
Immune signature on admission : phenotypic profile of blood T-cells
Time frame: Day 0
Immune signature will be compared between COVID-19 patients according to their clinical characteristics and outcome, together with SARS-CoV2 viral shedding (known for every patient in the cohort) on samples harvested on admission: a phenotypic profiling of blood T-cells by multicolor FACS analysis (using 30+ color panels analyzed by multiparametric flow cytometry) assessing T cell subsets (classical CD4 or CD8 T-cells as well as unconventional gdT-cells and regulatory T cells) through the expression of a wide range of surface and intracellular markers.
Immune signature on admission : inflammatory cytokines
Time frame: Day 0
Immune signature will be compared between COVID-19 patients according to their clinical characteristics and outcome, together with SARS-CoV2 viral shedding (known for every patient in the cohort) on samples harvested on admission: An analysis on plasma samples of concentration of a wide range of inflammatory cytokines such as IFNa, IFNb and IL-6.
4 secondary outcomes
Dynamics of cellular immunity: CD4 and CD8 T cells
Time frame: Day 0, Day 4, Day 8, Day 12, Day 30 (or in discharge)
Dynamics of cellular immunity: gd T cells
Time frame: Day 0, Day 4, Day 8, Day 12, Day 30 (or in discharge)
Dynamics of cellular immunity: T cell transcriptomic analysis
Time frame: Day 0, Day 4, Day 8, Day 12, Day 30 (or in discharge)
Dynamics of cellular immunity: humoral immunity
Time frame: Day 0, Day 4, Day 8, Day 12, 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 20 Mar 2026.
- Results publication: 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
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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.
Pierre DELOBEL, MD PhD principal investigator
University Hospital, Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by University Hospital, Toulouse at 2 sites 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 6 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 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 on admission : phenotypic profile of blood T-cells (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 NCT04668170, 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 20 Mar 2026.