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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04735588
• Other study ID #: ITP1021
• Status: Recruiting
• Start date: August 22, 2022
• Est. completion date: March 2024

Study information

• Verified date: August 2022
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: Paola Fazi
• Phone: +39 06 70390528
• Email: p.fazi[@]gimema.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: March 2024
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Immune Thrombocytopenia
• ITP
• ITP Secondary to Infection
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome

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