Predictive Immune Biomarkers of COVID-19 Pathogenesis to Influence Therapeutic Management (IMMUNOMARKCOV)

  • STATUS
    Recruiting
  • days left to enroll
    87
  • participants needed
    340
  • sponsor
    University Hospital, Toulouse
Updated on 5 April 2022

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 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.

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.

Details
Condition COVID-19
Treatment Blood collection on admission and longitudinally, Blood collection on their first consultation and 10 to 14 days later
Clinical Study IdentifierNCT04668170
SponsorUniversity Hospital, Toulouse
Last Modified on5 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Pregnancy or breastfeeding
Participation in another interventional clinical study involving exploratory treatment or blood sampling
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note