Clinical trial NCT06576102: Evaluation of Prevalence and Risk Factors of Persistent COVID-19 in Immunocompromised Patients
Official title: Evaluation of Prevalence and Risk Factors of Persistent SARS-CoV-2 Infection in Immunocompromised Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Persistent COVID-19
B Cell Malignancies
Keywords: COVID-19
Persistent SARS-CoV-2 infection
Immunocompromised patients
B cell malignancies
B cell targeting therapies
viral infections in the hematological patient
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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).

Eligibility 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

Primary outcomes:
measure: Prevalence of persisting SARS-CoV-2 infection among immunocompromised patients
timeFrame: Retrospective recruitment period will span from January 1st, 2022 to to the date of authorisation by hospital directorates following the Ethics Committees' approvals
Secondary outcomes:
measure: Risk factors for persisting COVID19
timeFrame: Retrospective recruitment period will span from January 1st, 2022 to to the date of authorisation by hospital directorates following the Ethics Committees' approvals
measure: Duration of viral shedding
timeFrame: Retrospective recruitment period will span from January 1st, 2022 to to the date of authorisation by hospital directorates following the Ethics Committees' approvals
measure: Duration of symptoms
timeFrame: Retrospective recruitment period will span from January 1st, 2022 to to the date of authorisation by hospital directorates following the Ethics Committees' approvals
measure: Prevalence of imaging alterations
timeFrame: Retrospective recruitment period will span from January 1st, 2022 to to the date of authorisation by hospital directorates following the Ethics Committees' approvals
measure: Re-infection within 120 days
timeFrame: Retrospective recruitment period will span from January 1st, 2022 to to the date of authorisation by hospital directorates following the Ethics Committees' approvals
measure: All-cause 120-day mortality
timeFrame: Retrospective recruitment period will span from January 1st, 2022 to to the date of authorisation by hospital directorates following the Ethics Committees' approvals
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Irccs Aoubo
city: Milan
country: Italy
facility: IRCCS Humanitas
city: Roma
country: Italy
facility: IRCCS INMI L. Spallanzani
city: Verona
country: Italy
facility: AOUI Verona
city: Seville
country: Spain
facility: Hospital Virgen Macarena
Study officials:
affiliation: University of Bologna
name: Maddalena Giannella, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: