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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: B Cell Malignancies; Persistent COVID-19
• Intervention / Treatment: Other: Persisting SARS-CoV-2 infection

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).

• Study Type: Observational
• Enrollment (Actual): 204

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Irccs Aoubo
  • Milan, Italy, 20089
    • IRCCS Humanitas
  • Roma, Italy, 00149
    • IRCCS INMI L. Spallanzani
  • Verona, Italy, 37126
    • AOUI Verona
• Spain
  • Seville, Spain, 41009
    • Hospital Virgen Macarena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with B cell malignancies; 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).

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Maddalena Giannella
• Investigators: Principal Investigator: Maddalena Giannella, MD PhD, University of Bologna

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: COVID-19; B cell malignancies; Immunocompromised patients; Persistent SARS-CoV-2 infection; B cell targeting therapies; viral infections in the hematological patient
• Additional Relevant MeSH Terms: Post-Infectious Disorders; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Post-Acute COVID-19 Syndrome; Neoplasms
• Other Study ID Numbers: PERsiCO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Since the study is conducted within the European Union's Horizon 2020 project named "ORCHESTRA" (grant agreement No 101016167), which will end on 30 November 2024, raw data will be available only after the end of the EU H2020 project on reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No