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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04932967

Enrollment

Registered

2021-06-21

Start date

2021-09-30

Completion date

2022-04-11

Last updated

2022-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Hematological Malignancy

Keywords

Neutralizing Monoclonal Antibodies

Brief summary

This is a multicenter retrospective, non-interventional observational study to evaluate the efficacy of nMoAbs in HM patients.

Detailed description

This is a multicenter retrospective, non-interventional observational study. The participating centres will retrospectively review all episodes of SARS-CoV-2 infection occurring in HMs identified at their institutions from February 2020 to May 2021 and treated with nMoAbs, to evaluate their efficacy.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 months

Design outcomes

Primary

Measure	Time frame	Description
time to SARS-nCov-2 test negativization	3 months	To assess the efficacy of nMoAbs in infected HM patients compared to the historical control

Countries

Italy

Outcome results