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

Maddalena Giannella

Status: Active, not recruiting

Conditions: Persistent COVID-19; B Cell Malignancies

Treatments: Other: Persisting SARS-CoV-2 infection

Study type: Observational

Funder types: Other

Identifiers

NCT06576102

PERsiCO

Details and patient eligibility

About

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.

Full 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).

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

204 participants in 1 patient group

Patients with B cell malignancies

Description:

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. 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).

Treatment:

Other: Persisting SARS-CoV-2 infection