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

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04735588

Collaborator

(none)

140

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Immune Thrombocytopenia ITP Covid19 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 Design

Study Type:

Observational

Anticipated Enrollment :

140 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gruppo Italiano Malattie EMatologiche dell'Adulto

ClinicalTrials.gov Identifier:

NCT04735588

Other Study ID Numbers:

ITP1021

First Posted:

Feb 3, 2021

Last Update Posted:

Aug 3, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Thrombocytopenia

Purpura, Thrombocytopenic, Idiopathic

Study Results

No Results Posted as of Aug 3, 2022