NCT06576102

Evaluation of Prevalence and Risk Factors of Persistent COVID-19 in Immunocompromised Patients

Evaluation of Prevalence and Risk Factors of Persistent SARS-CoV-2 Infection in Immunocompromised Patients

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 204 (actual)
• Sponsor: Maddalena Giannella · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Persistent COVID-19
• B Cell Malignancies

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-09-30
• Completion: 2025-09-30
• First posted: 2024-08-28
• Last updated: 2025-03-27

Locations

5 sites across 2 countries: Italy, Spain