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NCT04735588 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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