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Severe/Moderate CoronavirusCALPRONCT04953312

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

A study testing Blood samples in people with Severe/Moderate Coronavirus and Chronic Myelomonocytic Leukemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Blood samples
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteFrance
Study dates
Jan 2023to Jul 2024
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

  • 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:
Show all 12Show fewer
  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

France1 site
  • Gustave Roussy Institut

    Villejuif, 94800

Other trials in France

About this study

Official title: Calprotectin Involvement in Emergency Hematopoiesis Observed in Severe COVID-19

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.

Read the detailed description

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.

Being tested
Blood samples
Keywords
Calprotectin, hematopoiesis, COVID-19
Medical subject headings
Leukemia, Myelomonocytic, Chronic, Myelodysplastic Syndromes, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood samplesBiological

    blood

Study groups in NCT04953312
Study groupRoleWhat they receive
COVID-19 patients (group 1)ExperimentalPatients with a recent diagnosis (<7 days since first symptoms) of moderate or severe COVID-19
Receives: Biological: Blood samples
Chronic myeloid malignancies (group 2)ExperimentalAdults 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
Receives: Biological: Blood samples
Control group (group 3)OtherAge-matched healthy donors
Receives: Biological: Blood samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Differential gene expression and epigenetic signature of COVID-19 or leukemic versus normal HSC using CITE-seq and ATAC-seq

    Hematopoietic stem and progenitor cells from patients with severe or moderate COVID-19 or chronic myeloid malignancies or controls will be purified for analyses of transcriptome and chromatin conformation, and also functionally characterized using in vitro culture systems. Results will be compared between the three groups.

    Measured: 12 months

Secondary outcomes (1)
  1. Ex vivo testing of calprotectin-receptor interaction inhibitor

    Expression of targeted receptors will be monitored by flow cytometry. Clinically developed compounds that could inhibit calprotectin effects will be tested in vitro.

    Measured: During the last 6 months of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2021
  2. Study startJan 2023 (estimated)
  3. Primary completionDec 2023 (estimated)
  4. Study completionJul 2024 (estimated)

Why it stopped: Abandonment of the study project

Resources

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
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04953312
Sponsor's protocol ID
APHP210522
Other IDs
2021-A00674-37
Acronym
CALPRO
Status last verified
Mar 2026
First submitted
5 Jul 2021
Last updated
12 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Silvin A, Chapuis N, Dunsmore G, Goubet AG, Dubuisson A, Derosa L, Almire C, Henon C, Kosmider O, Droin N, Rameau P, Catelain C, Alfaro A, Dussiau C, Friedrich C, Sourdeau E, Marin N, Szwebel TA, Cantin D, Mouthon L, Borderie D, Deloger M, Bredel D, Mouraud S, Drubay D, Andrieu M, Lhonneur AS, Saada V, Stoclin A, Willekens C, Pommeret F, Griscelli F, Ng LG, Zhang Z, Bost P, Amit I, Barlesi F, Marabelle A, Pene F, Gachot B, Andre F, Zitvogel L, Ginhoux F, Fontenay M, Solary E. Elevated Calprotectin and Abnormal Myeloid Cell Subsets Discriminate Severe from Mild COVID-19. Cell. 2020 Sep 17;182(6):1401-1418.e18. doi: 10.1016/j.cell.2020.08.002. Epub 2020 Aug 5.

    PubMed 32810439
  • Shi H, Zuo Y, Yalavarthi S, Gockman K, Zuo M, Madison JA, Blair C, Woodward W, Lezak SP, Lugogo NL, Woods RJ, Lood C, Knight JS, Kanthi Y. Neutrophil calprotectin identifies severe pulmonary disease in COVID-19. J Leukoc Biol. 2021 Jan;109(1):67-72. doi: 10.1002/JLB.3COVCRA0720-359R. Epub 2020 Sep 1.

    PubMed 32869342
  • Udeh R, Advani S, de Guadiana Romualdo LG, Dolja-Gore X. Calprotectin, an Emerging Biomarker of Interest in COVID-19: A Systematic Review and Meta-Analysis. J Clin Med. 2021 Feb 15;10(4):775. doi: 10.3390/jcm10040775.

    PubMed 33672040
  • Abers MS, Delmonte OM, Ricotta EE, Fintzi J, Fink DL, de Jesus AAA, Zarember KA, Alehashemi S, Oikonomou V, Desai JV, Canna SW, Shakoory B, Dobbs K, Imberti L, Sottini A, Quiros-Roldan E, Castelli F, Rossi C, Brugnoni D, Biondi A, Bettini LR, D'Angio' M, Bonfanti P, Castagnoli R, Montagna D, Licari A, Marseglia GL, Gliniewicz EF, Shaw E, Kahle DE, Rastegar AT, Stack M, Myint-Hpu K, Levinson SL, DiNubile MJ, Chertow DW, Burbelo PD, Cohen JI, Calvo KR, Tsang JS; NIAID COVID-19 Consortium; Su HC, Gallin JI, Kuhns DB, Goldbach-Mansky R, Lionakis MS, Notarangelo LD. An immune-based biomarker signature is associated with mortality in COVID-19 patients. JCI Insight. 2021 Jan 11;6(1):e144455. doi: 10.1172/jci.insight.144455.

    PubMed 33232303
  • Bauer W, Diehl-Wiesenecker E, Ulke J, Galtung N, Havelka A, Hegel JK, Tauber R, Somasundaram R, Kappert K. Outcome prediction by serum calprotectin in patients with COVID-19 in the emergency department. J Infect. 2021 Apr;82(4):84-123. doi: 10.1016/j.jinf.2020.11.016. Epub 2020 Nov 17. No abstract available.

    PubMed 33217473
  • Luis Garcia de Guadiana Romualdo, Mulero MDR, Olivo MH, Rojas CR, Arenas VR, Morales MG, Abellan AB, Conesa-Zamora P, Garcia-Garcia J, Hernandez AC, Morell-Garcia D, Dolores Albaladejo-Oton M, Consuegra-Sanchez L. Circulating levels of GDF-15 and calprotectin for prediction of in-hospital mortality in COVID-19 patients: A case series. J Infect. 2021 Feb;82(2):e40-e42. doi: 10.1016/j.jinf.2020.08.010. Epub 2020 Aug 12. No abstract available.

    PubMed 32795482
  • Mahler M, Meroni PL, Infantino M, Buhler KA, Fritzler MJ. Circulating Calprotectin as a Biomarker of COVID-19 Severity. Expert Rev Clin Immunol. 2021 May;17(5):431-443. doi: 10.1080/1744666X.2021.1905526. Epub 2021 Apr 13.

    PubMed 33750254
  • Kaya T, Yaylaci S, Nalbant A, Yildirim I, Kocayigit H, Cokluk E, Sekeroglu MR, Koroglu M, Guclu E. Serum calprotectin as a novel biomarker for severity of COVID-19 disease. Ir J Med Sci. 2022 Feb;191(1):59-64. doi: 10.1007/s11845-021-02565-8. Epub 2021 Feb 27.

    PubMed 33641087

Questions about this trial

What is this clinical trial studying?

A study testing Blood samples in people with Severe/Moderate Coronavirus and Chronic Myelomonocytic Leukemia, run by Assistance Publique - Hôpitaux de Paris 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 12 inclusion and 5 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: withdrawn, as of the sponsor's last update on 12 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 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 was withdrawn before enrolling participants, so there are no results.

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?

Differential gene expression and epigenetic signature of COVID-19 or leukemic versus normal HSC using CITE-seq and ATAC-seq (time frame: 12 months). 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 NCT04953312, which also lists 8 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 12 Mar 2026.

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