Persistent COVID-19PERsiCONCT06576102
Evaluation of Prevalence and Risk Factors of Persistent COVID-19 in Immunocompromised Patients
An observational study of Persistent COVID-19 and B Cell Malignancies, run by Maddalena Giannella at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent COVID-19, B Cell Malignancies
- What is being tested?
- Persisting SARS-CoV-2 infection
- How many people
- 204 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Mar 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Italy4 sites
Irccs Aoubo
Bologna, Bologna, 40138
IRCCS Humanitas
Milan, Milan, 20089
IRCCS INMI L. Spallanzani
Roma, Roma, 00149
AOUI Verona
Verona, Verona, 37126
About this study
Official title: 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.
Read the 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
- Being tested
- Persisting SARS-CoV-2 infection
- Keywords
- COVID-19, Persistent SARS-CoV-2 infection, Immunocompromised patients, B cell malignancies, B cell targeting therapies, viral infections in the hematological patient
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Persisting SARS-CoV-2 infectionOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Persisting SARS-CoV-2 infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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 (6)
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: Retrospective recruitment period will span from January 1st, 2022 to to the date of authorisation by hospital directorates following the Ethics Committees' approvals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start1 Mar 2024
- Primary completion30 Sep 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maddalena Giannella
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maddalena Giannella, University of Bologna
- Investigators
- Maddalena Giannella, MD PhD, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576102
- Sponsor's protocol ID
- PERsiCO
- Acronym
- PERsiCO
- Status last verified
- May 2026
- First submitted
- 27 Aug 2024
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prevalence and Risk Factors of Persistent SARS-CoV-2 Infection in Immunocompromised Patients
- ClinicalTrials.gov ID
- NCT06576102
- Acronym / sponsor ID
- PERsiCO / PERsiCO
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Maddalena GiannellaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with B cell malignancies | – | Other: Persisting SARS-CoV-2 infectionAll 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Persisting SARS-CoV-2 infectionPrevalence 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) | Other | Patients with B cell malignancies |
Primary outcome
Prevalence of persisting SARS-CoV-2 infection among immunocompromised patients
Time frame: Retrospective recruitment period will span from January 1st, 2022 to to the date of authorisation by hospital directorates following the Ethics Committees' approvals
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)
6 secondary outcomes
Risk factors for persisting COVID19
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Retrospective recruitment period will span from January 1st, 2022 to to the date of authorisation by hospital directorates following the Ethics Committees' approvals
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Undecided. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maddalena Giannella, MD PhD principal investigator
University of Bologna
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent COVID-19 and B Cell Malignancies, run by Maddalena Giannella at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of persisting SARS-CoV-2 infection among immunocompromised patients (time frame: Retrospective recruitment period will span from January 1st, 2022 to to the date of authorisation by hospital directorates following the Ethics Committees' approvals). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.