Evaluation of Prevalence and Risk Factors of Persistent COVID-19 in Immunocompromised Patients
NCT Number: NCT06576102
Acronym: PERsiCO
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Persistent COVID-19|B Cell Malignancies
Interventions: OTHER: Persisting SARS-CoV-2 infection
Sponsor: Maddalena Giannella
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-29
Completion Date: 2025-09-30
Locations: Irccs Aoubo, Bologna, 40138, Italy|IRCCS Humanitas, Milan, 20089, Italy|IRCCS INMI L. Spallanzani, Roma, 00149, Italy|AOUI Verona, Verona, 37126, Italy|Hospital Virgen Macarena, Seville, 41009, Spain

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.

Primary Outcome Measures: Prevalence of persisting SARS-CoV-2 infection among immunocompromised patients, The first primary endpoint variable will be the rate of patients with persisting SARS-CoV-2 infection among study patients with new diagnosis of SARS Cov2 during the study period Persisting COVID19 will be 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), Retrospective recruitment period will span from January 1st, 2022 to to the date of authorisation by hospital directorates following the Ethics Committees' approvals
Secondary Outcome Measures: Risk factors for persisting COVID19, Univariate and multivariate analysis will be carried out to investigate factors associated with persisting COVID-19 among the study population, Retrospective recruitment period will span from January 1st, 2022 to to the date of authorisation by hospital directorates following the Ethics Committees' approvals|Duration of viral shedding, Duration of viral shedding, defined as the number of days between the first positive test and first negative PCR test, Retrospective recruitment period will span from January 1st, 2022 to to the date of authorisation by hospital directorates following the Ethics Committees' approvals|Duration of symptoms, Duration of symptoms, defined as the number of days between symptoms onset and the clinical cure, Retrospective recruitment period will span from January 1st, 2022 to to the date of authorisation by hospital directorates following the Ethics Committees' approvals|Prevalence of imaging alterations, Prevalence of imaging alterations, defined as the presence of new ground-glass and/or crazy paving and/or interstitial infiltrates at chest CT scan during the persisting infection (starting from 21 days after the first positive test until viral clearance), Retrospective recruitment period will span from January 1st, 2022 to to the date of authorisation by hospital directorates following the Ethics Committees' approvals|Re-infection within 120 days, Re-infection within 120 days, define as new positive test with or without symptoms after viral clearance has been achieved, Retrospective recruitment period will span from January 1st, 2022 to to the date of authorisation by hospital directorates following the Ethics Committees' approvals|All-cause 120-day mortality, All-cause 120-day mortality, Retrospective recruitment period will span from January 1st, 2022 to to the date of authorisation by hospital directorates following the Ethics Committees' approvals