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)

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

Study Overview

• Status: Completed
• Conditions: Covid19; Hematological Malignancy

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.

• Study Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy
    • Aou Consorziale Policlinico - Uo Ematologia Con Trapianto
  • Brescia, Italy
    • ASST degli Spedali Civili di Brescia
  • Como, Italy
    • Ospedale Valduce - Uos Ematologia
  • Firenze, Italy
    • AOU Careggi
  • Genova, Italy
    • IRCCS AOU San Martino
  • Milano, Italy
    • Fondazione Irccs "Istituto Nazionale Tumori"
  • Novara, Italy
    • AOU Maggiore della Carità di Novara
  • Padova, Italy
    • AOU Padova
  • Pisa, Italy
    • Aou Pisana - Uo Ematologia Universitaria
  • Roma, Italy
    • Fondazione Policlinico Universitario Agostino Gemelli-Irccs
  • Salerno, Italy
    • Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche
  • Siena, Italy
    • AOU Senese
  • Udine, Italy
    • Asui Di Udine, Presidio Ou "S. Maria Della Misericordia"
  • Varese, Italy
    • Asst Dei Sette Laghi, Ospedale Di Circolo E Fondazione Macchi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will include patients older than 18 years of age with HM who received nMoAbs, approved by AIFA, for the treatment of SARS-CoV-2 infection.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Publications and helpful links

General Publications

• Marasco 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. Erratum In: Br J Haematol. 2023 Mar;200(5):680.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Actual): April 11, 2022
• Study Completion (Actual): April 11, 2022

Study Registration Dates

• First Submitted: June 17, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 21, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Neutralizing Monoclonal Antibodies
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Neoplasms by Site; Hematologic Diseases; Neoplasms; COVID-19; Hematologic Neoplasms
• Other Study ID Numbers: EMATO0321

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No