Investigation on the Incidence and Course of COVID-19 in Patients With Prior, Ongoing or de Novo ITP. Evaluation of the Impact of COVID-19 Pandemic on the Management of ITP

IMMUNE THROMBOCYTOPENIA (ITP) AND COVID-19: National Retrospective and Prospective Observational Investigation on the Incidence and Course of COVID-19 in Patients With Prior, Ongoing or de Novo ITP. Evaluation of the Impact of COVID-19 Pandemic on the Management of ITP

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04735588

Enrollment

140

Registered

2021-02-03

Start date

2022-08-22

Completion date

2024-03-31

Last updated

2022-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Immune Thrombocytopenia, ITP, ITP Secondary to Infection

Brief summary

Multicenter retrospective and prospective observational study based on the collection of sequential anonymized data from principal Italian ITP centers, to describe the clinical course of ITP patients becoming infected by SARS-CoV-2 and of COVID-19 patients developing de novo ITP.

Detailed description

Multicenter retrospective and prospective observational study based on the collection - through pre-piloted electronic CRFs - of sequential anonymized data from principal Italian ITP centers representative of national geographical distribution, to evaluate, during a 2-years study period, both the cumulative incidence COVID-19 occurring in patients with prior or ongoing ITP (COVID-19 in ITP) and the cumulative incidence of de novo ITP manifesting during COVID-19 (ITP in COVID-19). Data will be collected to describe the clinical course of patients in the two groups. The enrolment period will last 24 months or terminate at the last day of 1-month-COVID-19 free in Italy, whichever comes first. Each patient will be followed up to the first visit scheduled as per common center practice, including at least six months after hospital discharge or end of quarantine home confinement.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥ 18 years * Confirmed diagnosed of ITP (ITP could be past, ongoing, persistent \>3 months, chronic \>12 months) in patients that are in regular follow-up (at least once a year) and who have been diagnosed with COVID-19 * All patients who develop de novo ITP from 1st January 2020 to the end of study after a diagnosis of COVID-19 or during the first 6 months after COVID-19 recovery * Signed informed consent

Exclusion criteria

• All subjects not fitting inclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Number of ITP patients in which COVID-19 occurs	24 months	Cumulative incidence of COVID-19 in adult patients with already known/ongoing ITP
Number of COVID-19 patients developing ITP	24 months	Cumulative incidence of adult patients with COVID-19 developing de novo ITP

Countries

Italy

Contacts

Primary ContactPaola Fazi

p.fazi@gimema.it+39 06 70390528

Backup ContactEnrico Crea

e.crea@gimema.it+39 06 70390514

Outcome results