Skip to main content
OpenTrials
Completed

NCT Number: NCT04932967

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Hematologic Diseases Hematologic Neoplasms Hematological Malignancy Hemic and Lymphatic Diseases Infections Lung Diseases Neoplasms Neoplasms by Site Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aou Consorziale Policlinico - Uo Ematologia Con Trapianto, Bari, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Nausea
  • Diarrhea
  • Myalgia
  • Dyspnea
  • Tachypnea
  • Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable).

Exclusion criteria

  • 1. 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

Treatment and study plan

Primary outcomes

  1. time to SARS-nCov-2 test negativization

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Other

Registry information

Official study title

Use of Neutralizing Monoclonal Antibodies for the Treatment of COVID-19 in Patients With Hematological Malignancies (SIE-GIMEMA Study)

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 21, 2021
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.