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Trial Title:
Evaluation of Prevalence and Risk Factors of Persistent COVID-19 in Immunocompromised Patients
NCT ID:
NCT06576102
Condition:
Persistent COVID-19
B Cell Malignancies
Conditions: Official terms:
COVID-19
Post-Acute COVID-19 Syndrome
Neoplasms
Conditions: Keywords:
COVID-19
Persistent SARS-CoV-2 infection
Immunocompromised patients
B cell malignancies
B cell targeting therapies
viral infections in the hematological patient
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
Persisting SARS-CoV-2 infection
Description:
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)
Arm group label:
Patients with B cell malignancies
Summary:
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.
Detailed description:
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).
Criteria for eligibility:
Study pop:
All immunocompromised adults (≥18 years) with a new SARS-CoV-2 infection assessed during
the study period, hospitalized or followed as outpatients in the participating centers,
will be screened for inclusion.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Irccs Aoubo
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Maddalena Giannella, MD PhD
Phone:
+39 051 214 3199
Email:
maddalena.giannella@unibo.it
Contact backup:
Last name:
Natascia Caroccia, PhD
Phone:
+39 051 214 3595
Email:
natascia.caroccia@unibo.it
Facility:
Name:
IRCCS Humanitas
Address:
City:
Milan
Zip:
20089
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Michele Bartoletti, MD PhD
Phone:
+39 02 82243647
Email:
michele.bartoletti@hunimed.eu
Facility:
Name:
IRCCS INMI L. Spallanzani
Address:
City:
Roma
Zip:
00149
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Alessandra D'Abramo, MD PhD
Phone:
+39 0655170232
Email:
alessandra.dabramo@inmi.it
Facility:
Name:
AOUI Verona
Address:
City:
Verona
Zip:
37126
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Mauro Krampera, MD PhD
Phone:
+39 045 8124420
Email:
mauro.krampera@univr.it
Facility:
Name:
Hospital Virgen Macarena
Address:
City:
Seville
Zip:
41009
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Jesús Rodríguez-Baño, MD PhD
Phone:
+34 698636733
Email:
jesusrb@us.es
Start date:
February 29, 2024
Completion date:
September 30, 2025
Lead sponsor:
Agency:
Maddalena Giannella
Agency class:
Other
Source:
University of Bologna
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06576102
