NCT04932967

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

September 30, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2022

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

6 months

First QC Date

June 17, 2021

Last Update Submit

June 21, 2022

Conditions

Covid19Hematological Malignancy

Keywords

Neutralizing Monoclonal Antibodies

Outcome Measures

Primary Outcomes (1)

  • time to SARS-nCov-2 test negativization

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

    3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • All patients must meet all the following criteria for study entry:
  • Age equal to or greater than 18 years of age.
  • Diagnosis of HM (acute leukemias, myelodysplastic syndromes, myeloproliferative neoplasms, lymphomas, myeloma, chronic myeloprolipherative disorders) at any stage/status.
  • Third generation rapid molecular or antigen test positive for SARS-CoV-2 from February 2020 until May 2021
  • Treatment with anti SARS CoV 2 nMoAbs approved by AIFA
  • Not hospitalized for COVID-19 at the time of nMoAbs administration
  • Not on oxygen therapy at the time of nMoAbs administration
  • At least one of the following symptoms for no more than 10 days:
  • Fever
  • Cough
  • Anosmia
  • Ageusia / dysgeusia
  • Pharyngodynia
  • Asthenia
  • Headache
  • +6 more criteria

You may not qualify if:

  • \. Hematological diseases, other than HM.
  • \. Not tested positive for SARS-CoV-2
  • \. Patients in disease remission "off therapy" for more than 6 months
  • \. Immune plasma treatment in the previous two months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Aou Consorziale Policlinico - Uo Ematologia Con Trapianto

Bari, Italy

Location

Asst Degli Spedali Civili Di Brescia

Brescia, Italy

Location

Ospedale Valduce - Uos Ematologia

Como, Italy

Location

Aou Careggi

Florence, Italy

Location

Irccs Aou San Martino

Genova, Italy

Location

Fondazione Irccs "Istituto Nazionale Tumori"

Milan, Italy

Location

Aou Maggiore Della Carità Di Novara

Novara, Italy

Location

AOU Padova

Padua, Italy

Location

Aou Pisana - Uo Ematologia Universitaria

Pisa, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli-Irccs

Roma, Italy

Location

Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche

Salerno, Italy

Location

Aou Senese

Siena, Italy

Location

Asui Di Udine, Presidio Ou "S. Maria Della Misericordia"

Udine, Italy

Location

Asst Dei Sette Laghi, Ospedale Di Circolo E Fondazione Macchi

Varese, Italy

Location

Related Publications (1)

  • 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.

    PMID: 35906881DERIVED

MeSH Terms

Conditions

COVID-19Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesNeoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2021

First Posted

June 21, 2021

Study Start

September 30, 2021

Primary Completion

April 11, 2022

Study Completion

April 11, 2022

Last Updated

June 22, 2022

Record last verified: 2022-06

Locations

IT(14)