Clinical trial NCT04735588: 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
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Immune Thrombocytopenia
ITP
Covid19
ITP Secondary to Infection
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with ITP becoming infected by SARS-CoV-2 and adult patients with COVID-19 developing de novo ITP, during a study period of two years, starting from 1st January 2020

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.

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

Primary outcomes:
measure: Number of ITP patients in which COVID-19 occurs
timeFrame: 24 months
measure: Number of COVID-19 patients developing ITP
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: ASST Degli Spedali Civili Di Brescia - UO Ematologia
city: Catania
country: Italy
facility: Unità di Onco-Ematologia - Azienda Ospedaliera Garibaldi
city: Firenze
country: Italy
facility: A.O.U. Careggi - Ematologia
city: Orbassano
country: Italy
facility: AOU San Luigi Gonzaga - SCDU Ematologia Generale E Oncoematologia
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Torino
country: Italy
facility: Ematologia Città della Salute e della Scienza di Torino - Molinette
city: Varese
country: Italy
facility: ASST Dei Sette Laghi - UOC Ematologia
city: Verona
country: Italy
facility: AOU Integrata Di Verona, Policlinico G.B. Rossi - UOC Ematologia
Study officials:
References: