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

Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)
Overall Status
Recruiting
CT.gov ID
NCT04932967
Collaborator
(none)
31
Enrollment
1
Location
3
Anticipated Duration (Months)
10.3
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 DiseaseIntervention/TreatmentPhase

    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
    Anticipated Enrollment :
    31 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
    Anticipated Primary Completion Date :
    Dec 1, 2021
    Anticipated Study Completion Date :
    Dec 31, 2021

    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

    SiteCityStateCountryPostal Code
    1Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali EmopoieticheSalernoItaly

    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:
    Oct 8, 2021
    Last Verified:
    Sep 1, 2021
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 8, 2021