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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Lymphocytic Leukemia
- Sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Enrollment
- 954
- Locations
- 15
- Primary Endpoint
- Assess the percentage of patients who develop severe COVID-19 infection
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •Signed informed consent, if applicable
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Assess the percentage of patients who develop severe COVID-19 infection
Time Frame: 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