Clinical trial · Interventional
Calprotectin, a Biomarker of COVID-19 Severity (CALPRO)
Calprotectin Involvement in Emergency Hematopoiesis Observed in Severe COVID-19
NCT04953312CI-TRIAL-00105357CALPROwithdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Abandonment of the study project
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myelomonocytic Leukemia | Chronic Myelomonocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Old Age | — | UNRESOLVED | — |
| Severe/Moderate Coronavirus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood samples | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- COVID-19 patients (group 1)
- description
- Patients with a recent diagnosis (\<7 days since first symptoms) of moderate or severe COVID-19
- interventionNames
- Biological: Blood samples
- type
- EXPERIMENTAL
- label
- Chronic myeloid malignancies (group 2)
- description
- 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
- interventionNames
- Biological: Blood samples
- type
- OTHER
- label
- Control group (group 3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (8)
- BACKGROUNDSilvin 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. PMID 32810439
- BACKGROUNDShi 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. PMID 32869342
- BACKGROUNDUdeh 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. PMID 33672040
- BACKGROUNDAbers 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. PMID 33232303
- BACKGROUNDBauer 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.