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NCT05803395 Clinical Trial

Incidence of Severe COVID-19 Infection in Patients With CLL or B-NHL Who Received Pre-exposure Prophylaxis With Tixagevimab and Cilgavimab in Italy.

COVID-19 Clinical Trial

Official title:
Incidence of Severe COVID-19 Infection in Patients With Chronic Lymphocytic Leukemia or Indolent B-cell Non-Hodgkin Lymphoma Who Received Pre-exposure Prophylaxis With Tixagevimab and Cilgavimab in Italy: an Observational Study by the GIMEMA Working Party on Chronic Lymphoproliferative Disorders and by the Fondazione Italiana Linfomi

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05803395
Other study ID # CLL2423
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 12, 2023
Est. completion date September 2024

Study information
Verified date November 2023
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact Paola Fazi
Phone 0670390528
Email p.fazi@gimema.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an observational retrospective and prospective multicenter study aimed at describing the role of the COVID -19 prophylaxis with Tixagevimab and Cilgavimab in CLL or indolent B-NHL patients who received first COVID-19 prophylaxis dose between March 2022 and October 2022.

Description:

This is an observational retrospective and prospective multicenter study aimed at describing the role of the COVID -19 prophylaxis with Tixagevimab and Cilgavimab in CLL or indolent B-NHL patients. All CLL or indolent B-cell NHL patients (follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma) who received first COVID-19 prophylaxis dose with Tixagevimab and Cilgavimab according to AIFA indication between March 2022 and October 2022 will be included in the study. Each patient will be followed for a maximum of 12 months from the first COVID-19 prophylaxis dose.

Recruitment information / eligibility
Status Recruiting
Enrollment 954
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age = 18 years 2. Patient with CLL or indolent B-NHL who received the first COVID-19 prophylaxis dose with Tixagevimab and Cilgavimab as per label indication between March 2022 and October 2022. 3. Signed informed consent, if applicable Exclusion Criteria: None

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy UOC Ematologia AO Cosenza Cosenza
Italy Ematologia AOU S.Anna Ferrara
Italy Ematologia AOU Careggi Firenze
Italy ASST Lecco Ospedale A.Manzoni Lecco
Italy UOC Ematologia ATMO Livorno
Italy ASST Grande Ospedale Metropolitano Niguarda Milano
Italy SCDU Ematologia Novara
Italy Dipartimento Oncologico La Maddalena Palermo
Italy UOC DI ONCOEMATOLOGIA AOR Villa Sofia - Cervello Palermo
Italy Ematologia Università "Sapienza" Roma Roma
Italy IRCCS Istituto Clinico Humanitas Rozzano
Italy UOC Ematologia Casa Sollievo della Sofferenza San Giovanni Rotondo
Italy SCDU Ematologia e terapie cellulari AO Mauriziano Torino
Italy Ematologia Ospedale S.Chiara Trento
Italy UOC ematologia ULSS2 Marca Trevigiana Treviso

Sponsors (2)
Lead Sponsor Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto Fondazione Italiana Linfomi

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assess the percentage of patients who develop severe COVID-19 infection Evaluation of prophylaxis efficacy in terms of percentage of patients with CLL or indolent B-NHL who develop severe COVID-19 infection, defined as COVID-19-related hospitalization or COVID -19 related death at 12 months
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