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
1 other identifier
observational
140
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2022
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2021
CompletedFirst Posted
Study publicly available on registry
February 3, 2021
CompletedStudy Start
First participant enrolled
August 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedAugust 26, 2022
August 1, 2022
9 months
February 2, 2021
August 24, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
Eligibility Criteria
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
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
ASST Degli Spedali Civili Di Brescia - UO Ematologia
Brescia, Italy
Unità di Onco-Ematologia - Azienda Ospedaliera Garibaldi
Catania, Italy
A.O.U. Careggi - Ematologia
Florence, Italy
AOU San Luigi Gonzaga - SCDU Ematologia Generale E Oncoematologia
Orbassano, Italy
Policlinico Universitario Agostino Gemelli
Roma, Italy
Ematologia Città della Salute e della Scienza di Torino - Molinette
Torino, Italy
ASST Dei Sette Laghi - UOC Ematologia
Varese, Italy
AOU Integrata Di Verona, Policlinico G.B. Rossi - UOC Ematologia
Verona, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2021
First Posted
February 3, 2021
Study Start
August 22, 2022
Primary Completion
June 1, 2023
Study Completion
March 1, 2024
Last Updated
August 26, 2022
Record last verified: 2022-08