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MPN Clinical Trial Finder

Clinical Trial Finder

Search Results

Calprotectin, a Biomarker of COVID-19 Severity (CALPRO)

Study Purpose

The purpose of this study is to provide new insights into the pathophysiology of emergency hematopoiesis detected in severe COVID-19 patients. The investigators aim to explore the ability of calprotectin to induce an immunosuppressive myeloid program at the hematopoietic stem and progenitor cell (HSPC) level, and to identify the receptor(s) involved in this effect. Since patients with a hematological malignancy demonstrate a very high propensity to develop a severe COVID-19, the investigators will explore how HSPCs collected from patients with a myeloid malignancy respond to calprotectin.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Criteria for all groups:
  • - Adults ≥ 18 years.
  • - Dated and signed inform consent * - * : written informed consent of relative (trusted person, close family) in case of emergency procedure, by default emergency inclusion notified in medical file and pursuance consent sought.
  • - Affiliation with a social security scheme.
Criteria for control group:
  • - Age-matched healthy donors.
Criteria for chronic myeloid malignancies:
  • - A diagnosis of low or high-risk myelodysplastic syndromes according to the WHO 2016 classification.
  • - A diagnosis of dysplastic or proliferative chronic myelomonocytic leukemia according to WHO 2016.
Criteria for COVID-19 patients:
  • - Patients with a recent diagnosis (<7 days since first symptoms) of moderate or severe COVID-19.

Exclusion Criteria:

  • - Pregnant women.
  • - Minor patient or major under protection.
  • - Patients with COVID-19 infection and active cancer or a history of cancer within the last 6 months.
- Patients with COVID-19 and severe comorbidities including cardiovascular or respiratory diseases, unbalanced diabetes, obesity (IMC >29) - Patient on AME (state medical aid)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04953312
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Assistance Publique - Hôpitaux de Paris
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Michaela FONTENAY, PhDEric SOLARY, MD
Principal Investigator Affiliation Assistance Publique - Hôpitaux de ParisGustave Roussy Institut
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Severe/Moderate Coronavirus, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndromes, Old Age
Study Website: View Trial Website
Additional Details

Emergency myelopoiesis in response to SARS-CoV-2 infection produce immunosuppressive myeloid cells with accumulation of immature granulocytes and loss of non-classical monocytes. Excessive release of calprotectin, the dimer of S100A8/A9 alarmins, by immature granulocytes and activated monocytes reflects this situation. A role of calprotectin has been previously described in the initiation and progression of chronic hematological malignancies such as myelodysplastic syndromes. To provide a rationale for the targeting of alarmin-driven signaling pathways and limit the pathogenic inflammatory response to SARS-CoV-2 infection, the role of calprotectin in the production of immunosuppressive cells from the bone marrow hematopoietic stem and progenitors cells needs to be investigated in patients with severe COVID-19 in comparison with patients with chronic myeloid malignancies (such as chronic myelomonocytic leukemia and myelodysplastic syndromes) and with age-mached healthy controls. A comprehensive and integrated multiomics approach will be used to decipher the features of immunosuppressive cells and identify therapeutic targets in deregulated pathways.

Arms & Interventions

Arms

Experimental: COVID-19 patients (group 1)

Patients with a recent diagnosis (<7 days since first symptoms) of moderate or severe COVID-19

Experimental: Chronic myeloid malignancies (group 2)

Adults with chronic myeloid malignancies including myelodysplastic syndromes with low risk MDS ; high risk MDS according to IPSS-R or with dysplastic or proliferative chronic myelomonocytic leukemia according to WHO2016

Other: Control group (group 3)

Age-matched healthy donors

Interventions

Biological: - Blood samples

blood

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Gustave Roussy Institut, Villejuif, France

Status

Address

Gustave Roussy Institut

Villejuif, , 94800

Site Contact

Nathalie DROIN, PhD

[email protected]

+33 1 42 11 63 02

Nearest Location

Site Contact

Nathalie DROIN, PhD

[email protected]

+33 1 42 11 63 02

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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