Incidence of Severe COVID-19 Infection in Patients With CLL or B-NHL Who Received Pre-exposure Prophylaxis With Tixagevimab and Cilgavimab in Italy.
1 other identifier
observational
954
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2023
Shorter than P25 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2023
CompletedFirst Posted
Study publicly available on registry
April 7, 2023
CompletedStudy Start
First participant enrolled
September 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedNovember 28, 2023
November 1, 2023
12 months
April 6, 2023
November 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
Patients with CLL or indolent B-NHL (follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma) who received the Tixagevimab and Cilgavimab as per Agenzia Italiana del Farmaco (AIFA) indications.
You may qualify if:
- Age ≥ 18 years
- 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.
- Signed informed consent, if applicable
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
UOC Ematologia AO Cosenza
Cosenza, Italy
Ematologia AOU S.Anna
Ferrara, Italy
Ematologia AOU Careggi
Florence, Italy
ASST Lecco Ospedale A.Manzoni
Lecco, Italy
UOC Ematologia ATMO
Livorno, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, 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, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gian Matteo Rigolin
Ematologia - Azienda Ospedaliero Universitaria S.Anna di Ferrara
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2023
First Posted
April 7, 2023
Study Start
September 12, 2023
Primary Completion
September 1, 2024
Study Completion
September 1, 2024
Last Updated
November 28, 2023
Record last verified: 2023-11