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

Recruiting

• Conditions: Indolent B-Cell Non-Hodgkin Lymphoma; COVID-19; Chronic Lymphocytic Leukemia

• Registration Number: NCT05803395
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-04-06
• Study First Submitted QC: 2023-04-06
• Study First Posted: 2023-04-07
• Study Start: 2023-09-12
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-28
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 954

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the percentage of patients who develop severe COVID-19 infection	at 12 months	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

Trial Locations

Locations (15)

UOC Ematologia AO Cosenza; 🇮🇹 Cosenza, Italy

Ematologia AOU S.Anna; 🇮🇹 Ferrara, Italy

Ematologia AOU Careggi; 🇮🇹 Firenze, Italy

ASST Lecco Ospedale A.Manzoni; 🇮🇹 Lecco, Italy

SCDU Ematologia; 🇮🇹 Novara, Italy

Ematologia Università "Sapienza" Roma; 🇮🇹 Roma, Italy

IRCCS Istituto Clinico Humanitas; 🇮🇹 Rozzano, Italy

SCDU Ematologia e terapie cellulari AO Mauriziano; 🇮🇹 Torino, Italy

Ematologia Ospedale S.Chiara; 🇮🇹 Trento, Italy

UOC ematologia ULSS2 Marca Trevigiana; 🇮🇹 Treviso, Italy

UOC Ematologia ATMO; 🇮🇹 Livorno, Italy

ASST Grande Ospedale Metropolitano Niguarda; 🇮🇹 Milano, Italy

Dipartimento Oncologico La Maddalena; 🇮🇹 Palermo, Italy

UOC DI ONCOEMATOLOGIA AOR Villa Sofia - Cervello; 🇮🇹 Palermo, Italy

UOC Ematologia Casa Sollievo della Sofferenza; 🇮🇹 San Giovanni Rotondo, Italy