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

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

• Study Contact: Name: Paola Fazi; Phone Number: +39 06 70390528; Email: p.fazi@gimema.it

Study Locations

• Italy
  • Brescia, Italy
    • Recruiting
    • Asst Degli Spedali Civili Di Brescia - Uo Ematologia
    • Contact: Mariella D'Adda
  • Catania, Italy
    • Recruiting
    • Unità di Onco-Ematologia - Azienda Ospedaliera Garibaldi
    • Contact: Ugo Consoli
  • Firenze, Italy
    • Recruiting
    • A.O.U. Careggi - Ematologia
    • Contact: Valentina Carrai
  • Orbassano, Italy
    • Recruiting
    • AOU San Luigi Gonzaga - SCDU Ematologia Generale E Oncoematologia
    • Contact: Alessandro Morotti
  • Roma, Italy
    • Recruiting
    • Policlinico Universitario Agostino Gemelli
    • Contact: Elena Rossi
  • Torino, Italy
    • Recruiting
    • Ematologia Città della Salute e della Scienza di Torino - Molinette
    • Contact: Alessandra Borchiellini
  • Varese, Italy
    • Recruiting
    • ASST Dei Sette Laghi - UOC Ematologia
    • Contact: Domenica Caramazza
  • Verona, Italy
    • Recruiting
    • Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Hematologic Diseases; Hemorrhage; Hemorrhagic Disorders; Blood Coagulation Disorders; Skin Manifestations; Blood Platelet Disorders; Thrombotic Microangiopathies; Purpura, Thrombocytopenic; Purpura; COVID-19; Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia
• Other Study ID Numbers: ITP1021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No