Clinical trial · Observational
Use of nMoABs for the Treatment of COVID-19 in Patients With HM.
Use of Neutralizing Monoclonal Antibodies for the Treatment of COVID-19 in Patients With Hematological Malignancies (SIE-GIMEMA Study)
NCT04932967CI-TRIAL-00059226completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter retrospective, non-interventional observational study to evaluate the efficacy of nMoAbs in HM patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Covid19 | — | UNRESOLVED | — |
| Hematological Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- time to SARS-nCov-2 test negativization
- timeFrame
- 3 months
- description
- To assess the efficacy of nMoAbs in infected HM patients compared to the historical control
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* All patients must meet all the following criteria for study entry:
1. Age equal to or greater than 18 years of age.
2. Diagnosis of HM (acute leukemias, myelodysplastic syndromes, myeloproliferative neoplasms, lymphomas, myeloma, chronic myeloprolipherative disorders) at any stage/status.
3. Third generation rapid molecular or antigen test positive for SARS-CoV-2 from February 2020 until May 2021
4. Treatment with anti SARS CoV 2 nMoAbs approved by AIFA
5. Not hospitalized for COVID-19 at the time of nMoAbs administration
6. Not on oxygen therapy at the time of nMoAbs administration
7. At least one of the following symptoms for no more than 10 days:
* Fever
* Cough
* Anosmia
* Ageusia / dysgeusia
* Pharyngodynia
* Asthenia
* Headache
* Nausea
* Diarrhea
* Myalgia
* Dyspnea
* Tachypnea
8. Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable).
Exclusion Criteria:
* 1\. Hematological diseases, other than HM.
2\. Not tested positive for SARS-CoV-2
3\. Patients in disease remission "off therapy" for more than 6 months
4\. Immune plasma treatment in the previous two monthsReferences
Publications (1)
- DERIVEDMarasco V, Piciocchi A, Candoni A, Pagano L, Guidetti A, Musto P, Bruna R, Bocchia M, Visentin A, Turrini M, Tucci A, Pilerci S, Fianchi L, Salvini M, Galimberti S, Coviello E, Selleri C, Luppi M, Crea E, Fazi P, Passamonti F, Corradini P. Neutralizing monoclonal antibodies in haematological patients paucisymptomatic for COVID-19: The GIMEMA EMATO-0321 study. Br J Haematol. 2022 Oct;199(1):54-60. doi: 10.1111/bjh.18385. Epub 2022 Jul 30. PMID 35906881