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

NCT ID: NCT04735588

Last Updated: 2022-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-22

Study Completion Date

2024-03-31

Brief Summary

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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

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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.

Conditions

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Immune Thrombocytopenia ITP Covid19 ITP Secondary to Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ASST Degli Spedali Civili Di Brescia - UO Ematologia

Brescia, , Italy

Site Status RECRUITING

Unità di Onco-Ematologia - Azienda Ospedaliera Garibaldi

Catania, , Italy

Site Status RECRUITING

A.O.U. Careggi - Ematologia

Florence, , Italy

Site Status RECRUITING

AOU San Luigi Gonzaga - SCDU Ematologia Generale E Oncoematologia

Orbassano, , Italy

Site Status RECRUITING

Policlinico Universitario Agostino Gemelli

Roma, , Italy

Site Status RECRUITING

Ematologia Città della Salute e della Scienza di Torino - Molinette

Torino, , Italy

Site Status RECRUITING

ASST Dei Sette Laghi - UOC Ematologia

Varese, , Italy

Site Status RECRUITING

AOU Integrata Di Verona, Policlinico G.B. Rossi - UOC Ematologia

Verona, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Paola Fazi

Role: CONTACT

+39 06 70390528

Enrico Crea

Role: CONTACT

+39 06 70390514

Facility Contacts

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Mariella D'Adda

Role: primary

Ugo Consoli

Role: primary

Valentina Carrai

Role: primary

Alessandro Morotti

Role: primary

Elena Rossi

Role: primary

Alessandra Borchiellini

Role: primary

Domenica Caramazza

Role: primary

Carlo Visco

Role: primary

Other Identifiers

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ITP1021

Identifier Type: -

Identifier Source: org_study_id

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