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

• Conditions: Immune Thrombocytopenia; Covid19; ITP Secondary to Infection; ITP

• Registration Number: NCT04735588
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Study Timeline

• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-03
• Status Verified: 2022-08
• Study Start: 2022-08-22
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-26
• Primary Completion: 2023-06
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of COVID-19 patients developing ITP	24 months	Cumulative incidence of adult patients with COVID-19 developing de novo ITP
Number of ITP patients in which COVID-19 occurs	24 months	Cumulative incidence of COVID-19 in adult patients with already known/ongoing ITP

Trial Locations

Locations (8)

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

A.O.U. Careggi - Ematologia; 🇮🇹 Firenze, Italy

ASST Dei Sette Laghi - UOC Ematologia; 🇮🇹 Varese, Italy

Policlinico Universitario Agostino Gemelli; 🇮🇹 Roma, Italy

ASST Degli Spedali Civili Di Brescia - UO Ematologia; 🇮🇹 Brescia, Italy

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

Unità di Onco-Ematologia - Azienda Ospedaliera Garibaldi; 🇮🇹 Catania, Italy

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