Spontaneous international multicenter retrospective and prospective observational studywhich objective is to evaluate the prevalence and risk factors of persistent SARS-CoV-2infection within a population of hematology patients with humoral immunity deficiency.
Spontaneous international multicenter retrospective and prospective observational study
which objective is to evaluate the prevalence and risk factors of persistent SARS-CoV-2
infection within a population of hematology patients with humoral immunity deficiency.
The retrospective recruitment period will span from January, 1st, 2022 to the date of
authorisation by hospital directorates following the Ethics Committees' approvals. This
period has been established considering the prevalent diffusion of the omicron variant
and its subvariants, which has led to significant changes in the clinical manifestations
of COVID-19. The prospective recruitment will be carried out over the 12 months
immediately following the retrospective period. During the study period, screening for
persisting SARS-CoV-2 infection and therapeutic management of all patients will be
carried out by the attending physicians according to routine practice.
This study is enclosed in the EU Horizon 2020 project "Connecting European Cohorts to
Increase Common and Effective Response to SARS-CoV-2 Pandemic: ORCHESTRA" (Grant
Agreement No. 101016167) and is located within Task 4.6 "Prevalence, risk factors and
therapeutic management of persistent COVID-19 in frail patients." It is expected to
enroll approximately 1,000 patients (500 at the coordinating center).
Other: Persisting SARS-CoV-2 infection
Prevalence of persisting SARS-CoV-2 infection among immunocompromised patients defined as
the persistence or the recurrence of symptoms and signs (fever, dyspnea, hypoxemia,
changes on chest-X ray or CT scan) and positive SARS-CoV-2 PCR ≥ 21 days after the time 0
(day of the first test positive for SARS-CoV-2 infection)
Inclusion Criteria:
- Diagnosis of B cell malignancies or previous treatment with B cell targeting
therapies.
- Diagnosis of proven SARS-CoV-2 infection confirmed by a PCR test (only the first
infection during the study period will be considered, re-infection will be counted
as a secondary endpoint).
- Provision of signed and dated informed consent.
Exclusion Criteria:
- None
Irccs Aoubo
Bologna, Italy
IRCCS Humanitas
Milan, Italy
IRCCS INMI L. Spallanzani
Roma, Italy
AOUI Verona
Verona, Italy
Hospital Virgen Macarena
Seville, Spain
Maddalena Giannella, MD PhD, Principal Investigator
University of Bologna