Official Title
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
Brief Summary

Multicenter retrospective and prospective observational study based on the collection ofsequential anonymized data from principal Italian ITP centers, to describe the clinicalcourse of ITP patients becoming infected by SARS-CoV-2 and of COVID-19 patientsdeveloping 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.

Unknown status
Immune Thrombocytopenia
ITP
COVID19
ITP Secondary to Infection
Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Italy
Locations

ASST Degli Spedali Civili Di Brescia - UO Ematologia
Brescia, Italy

Unità di Onco-Ematologia - Azienda Ospedaliera Garibaldi
Catania, Italy

A.O.U. Careggi - Ematologia
Firenze, Italy

AOU San Luigi Gonzaga - SCDU Ematologia Generale E Oncoematologia
Orbassano, Italy

Policlinico Universitario Agostino Gemelli
Roma, Italy

Ematologia Città della Salute e della Scienza di Torino - Molinette
Torino, Italy

ASST Dei Sette Laghi - UOC Ematologia
Varese, Italy

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

Contacts

Paola Fazi
+39 06 70390528
p.fazi@gimema.it

Enrico Crea
+39 06 70390514
e.crea@gimema.it

Gruppo Italiano Malattie EMatologiche dell'Adulto
NCT Number
MeSH Terms
COVID-19
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic