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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04735588
Recruitment Status : Recruiting
First Posted : February 3, 2021
Last Update Posted : August 26, 2022
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Study Description
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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
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
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Study Type : Observational
Estimated 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
Actual Study Start Date : August 22, 2022
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of ITP patients in which COVID-19 occurs [ Time Frame: 24 months ]
    Cumulative incidence of COVID-19 in adult patients with already known/ongoing ITP

  2. Number of COVID-19 patients developing ITP [ Time Frame: 24 months ]
    Cumulative incidence of adult patients with COVID-19 developing de novo ITP


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04735588


Contacts
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Contact: Paola Fazi +39 06 70390528 p.fazi@gimema.it
Contact: Enrico Crea +39 06 70390514 e.crea@gimema.it

Locations
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Italy
ASST Degli Spedali Civili Di Brescia - UO Ematologia Recruiting
Brescia, Italy
Contact: Mariella D'Adda         
Unità di Onco-Ematologia - Azienda Ospedaliera Garibaldi Recruiting
Catania, Italy
Contact: Ugo Consoli         
A.O.U. Careggi - Ematologia Recruiting
Firenze, Italy
Contact: Valentina Carrai         
AOU San Luigi Gonzaga - SCDU Ematologia Generale E Oncoematologia Recruiting
Orbassano, Italy
Contact: Alessandro Morotti         
Policlinico Universitario Agostino Gemelli Recruiting
Roma, Italy
Contact: Elena Rossi         
Ematologia Città della Salute e della Scienza di Torino - Molinette Recruiting
Torino, Italy
Contact: Alessandra Borchiellini         
ASST Dei Sette Laghi - UOC Ematologia Recruiting
Varese, Italy
Contact: Domenica Caramazza         
AOU Integrata Di Verona, Policlinico G.B. Rossi - UOC Ematologia Recruiting
Verona, Italy
Contact: Carlo Visco         
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
More Information
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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT04735588    
Other Study ID Numbers: ITP1021
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: August 26, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
 Respiratory Tract Diseases
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations