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

Last updated: August 24, 2022
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Overall Status: Active - Recruiting

Phase

N/A

Condition

Covid-19

Platelet Disorders

Dysfunctional Uterine Bleeding

Treatment

N/A

Clinical Study ID

NCT04735588
ITP1021
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 whohave been diagnosed with COVID-19
  • All patients who develop de novo ITP from 1st January 2020 to the end of study after adiagnosis of COVID-19 or during the first 6 months after COVID-19 recovery
  • Signed informed consent

Exclusion

Exclusion Criteria:

• All subjects not fitting inclusion criteria

Study Design

Total Participants: 140
Study Start date:
August 22, 2022
Estimated Completion Date:
March 31, 2024

Study 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.

Connect with a study center

  • ASST Degli Spedali Civili Di Brescia - UO Ematologia

    Brescia,
    Italy

    Active - Recruiting

  • Unità di Onco-Ematologia - Azienda Ospedaliera Garibaldi

    Catania,
    Italy

    Active - Recruiting

  • A.O.U. Careggi - Ematologia

    Firenze,
    Italy

    Active - Recruiting

  • AOU San Luigi Gonzaga - SCDU Ematologia Generale E Oncoematologia

    Orbassano,
    Italy

    Active - Recruiting

  • Policlinico Universitario Agostino Gemelli

    Roma,
    Italy

    Active - Recruiting

  • Ematologia Città della Salute e della Scienza di Torino - Molinette

    Torino,
    Italy

    Active - Recruiting

  • ASST Dei Sette Laghi - UOC Ematologia

    Varese,
    Italy

    Active - Recruiting

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

    Verona,
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.