Immune ThrombocytopeniaNCT04735588
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
An observational study of Immune Thrombocytopenia and ITP, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 8 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Thrombocytopenia, ITP, Covid19
- How many people
- 140 participants
- Where
- 8 sitesItaly
- Study dates
- 22 Aug 2022to Mar 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- All subjects not fitting inclusion criteria
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites, 8 recruiting
- Recruiting
ASST Degli Spedali Civili Di Brescia - UO Ematologia
Brescia
Mariella D'Adda
- Recruiting
Unità di Onco-Ematologia - Azienda Ospedaliera Garibaldi
Catania
Ugo Consoli
- Recruiting
A.O.U. Careggi - Ematologia
Florence
Valentina Carrai
- Recruiting
AOU San Luigi Gonzaga - SCDU Ematologia Generale E Oncoematologia
Orbassano
Alessandro Morotti
- Recruiting
Policlinico Universitario Agostino Gemelli
Roma
Elena Rossi
- Recruiting
Ematologia Città della Salute e della Scienza di Torino - Molinette
Torino
Alessandra Borchiellini
- Recruiting
ASST Dei Sette Laghi - UOC Ematologia
Varese
Domenica Caramazza
- Recruiting
AOU Integrata Di Verona, Policlinico G.B. Rossi - UOC Ematologia
Verona
Carlo Visco
About this study
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
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.
Read the 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.
- Conditions
- Immune Thrombocytopenia, ITP, Covid19, ITP Secondary to Infection
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ITP patients in which COVID-19 occurs
Cumulative incidence of COVID-19 in adult patients with already known/ongoing ITP
Measured: 24 months
Number of COVID-19 patients developing ITP
Cumulative incidence of adult patients with COVID-19 developing de novo ITP
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start22 Aug 2022
- Primary completionJun 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735588
- Sponsor's protocol ID
- ITP1021
- Status last verified
- Aug 2022
- First submitted
- 2 Feb 2021
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No