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Use of nMoABs for the Treatment of COVID-19 in Patients With HM.

Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)
Overall Status
Completed
CT.gov ID
NCT04932967
Collaborator
(none)
91
Enrollment
14
Locations
6.3
Actual Duration (Months)
6.5
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    91 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Use of Neutralizing Monoclonal Antibodies for the Treatment of COVID-19 in Patients With Hematological Malignancies (SIE-GIMEMA Study)
    Actual Study Start Date :
    Sep 30, 2021
    Actual Primary Completion Date :
    Apr 11, 2022
    Actual Study Completion Date :
    Apr 11, 2022

    Outcome Measures

    Primary Outcome Measures

    1. time to SARS-nCov-2 test negativization [3 months]

      To assess the efficacy of nMoAbs in infected HM patients compared to the historical control

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable).
    Exclusion Criteria:
      1. Hematological diseases, other than HM.

    1. Not tested positive for SARS-CoV-2

    2. Patients in disease remission "off therapy" for more than 6 months

    3. Immune plasma treatment in the previous two months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aou Consorziale Policlinico - Uo Ematologia Con Trapianto Bari Italy
    2 Asst Degli Spedali Civili Di Brescia Brescia Italy
    3 Ospedale Valduce - Uos Ematologia Como Italy
    4 Aou Careggi Firenze Italy
    5 Irccs Aou San Martino Genova Italy
    6 Fondazione Irccs "Istituto Nazionale Tumori" Milano Italy
    7 Aou Maggiore Della Carità Di Novara Novara Italy
    8 AOU Padova Padova Italy
    9 Aou Pisana - Uo Ematologia Universitaria Pisa Italy
    10 Fondazione Policlinico Universitario Agostino Gemelli-Irccs Roma Italy
    11 Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche Salerno Italy
    12 Aou Senese Siena Italy
    13 Asui Di Udine, Presidio Ou "S. Maria Della Misericordia" Udine Italy
    14 Asst Dei Sette Laghi, Ospedale Di Circolo E Fondazione Macchi Varese Italy

    Sponsors and Collaborators

    • Gruppo Italiano Malattie EMatologiche dell'Adulto

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gruppo Italiano Malattie EMatologiche dell'Adulto
    ClinicalTrials.gov Identifier:
    NCT04932967
    Other Study ID Numbers:
    • EMATO0321
    First Posted:
    Jun 21, 2021
    Last Update Posted:
    Jun 22, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto
    Neutralizing Monoclonal Antibodies
    Additional relevant MeSH terms:
    COVID-19
    Neoplasms
    Hematologic Neoplasms

    Study Results

    No Results Posted as of Jun 22, 2022