- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT04930731
Risk Factors and Characteristics of COVID 19 Infection in Patients With Haematological Diseases
- assessment of risk factor of covid 19 in haematological patients
- assessment of characteristics of covid 19 in haematological patients
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
An ongoing outbreak of pneumonia associated with a novel coronavirus, severe acute respiratory syndrome (SARS) coronavirus 2, was reported in Wuhan, Hubei Province, China, in December 2019 .
In the following weeks, infections spread across China and other countries around the world .
The Chinese public health, clinical, and scientific communities took action to allow for timely recognition of the new virus and shared the viral gene sequence to the world .
On January 30, 2020, the World Health Organization (WHO) declared the outbreak a Public Health Emergency of International Concern
. On February 12, 2020, the WHO named the disease caused by the novel coronavirus "coronavirus disease 2019" (COVID-19) .
A group of international experts, with a range of specializations, have worked with Chinese counterparts to try to contain the outbreak .
Preliminary reports suggest that patients with an underlying malignancy have inferior outcomes.
While haematology patients are thought to be at increased risk of developing severe complications both due to immune dysfunction from their underlying haematological disorder and immunosuppressive therapies used for treatment, delays in treatment of the underling malignancy may compromise patient safety and survival. Data from other cohorts worldwide suggest mortality from COVID-19 is higher in haematology patients compared to the general population, with reported mortality rates between 39% and 50% in other British haematology patient cohorts.
In particular, a recent UK case series reported significantly higher case fatality rates in haematology patients receiving immunosuppressive or cytotoxic therapy within three months of COVID-19 diagnosis, raising concerns about the delivery of systemic anti-cancer therapy (SACT) during the pandemic.
There is an ongoing need to share collective experience regarding the clinical course of COVID-19 in patients with haematological disorders, particularly regarding implications for SACT delivery, in order to enable patients to receive treatment in a timely and safe manner during the pandemic.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studiecontact
- Naam: Aya Nemr, Master
- Telefoonnummer: 0201097069179
- E-mail: Ayah.nemr@yahoo.com
Studie Contact Back-up
- Naam: Essam E Mohamed
- Telefoonnummer: 0201001971906
- E-mail: essamabdelmohsen@aun.edu.eg
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- patients with haematological diseases who suspected or confirmed to COVID 19 infection..
- patients with age more than 18 years old
Exclusion Criteria:
- patients under the age of 18.
- Patients who refuse to contribute in this study.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Risk Factors and Characteristics of COVID 19 infection in Patients with Haematological Diseases
Tijdsspanne: From September 2021 to June 2022
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To identify risk factors and characteristics of COVID 19 in patients with haematological diseases
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From September 2021 to June 2022
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Safaa A Ahmed, safaakhaled2003@gmail.com
Publicaties en nuttige links
Algemene publicaties
- Blimark C, Holmberg E, Mellqvist UH, Landgren O, Bjorkholm M, Hultcrantz M, Kjellander C, Turesson I, Kristinsson SY. Multiple myeloma and infections: a population-based study on 9253 multiple myeloma patients. Haematologica. 2015 Jan;100(1):107-13. doi: 10.3324/haematol.2014.107714. Epub 2014 Oct 24.
- Hilal T, Gea-Banacloche JC, Leis JF. Chronic lymphocytic leukemia and infection risk in the era of targeted therapies: Linking mechanisms with infections. Blood Rev. 2018 Sep;32(5):387-399. doi: 10.1016/j.blre.2018.03.004. Epub 2018 Mar 16.
- Chemaly RF, Ghosh S, Bodey GP, Rohatgi N, Safdar A, Keating MJ, Champlin RE, Aguilera EA, Tarrand JJ, Raad II. Respiratory viral infections in adults with hematologic malignancies and human stem cell transplantation recipients: a retrospective study at a major cancer center. Medicine (Baltimore). 2006 Sep;85(5):278-287. doi: 10.1097/01.md.0000232560.22098.4e.
- Pinana JL, Gomez MD, Montoro J, Lorenzo I, Perez A, Gimenez E, Gonzalez-Barbera EM, Carretero C, Guerreiro M, Salavert M, Sanz G, Hernandez-Boluda JC, Borras R, Sanz J, Solano C, Navarro D. Incidence, risk factors, and outcome of pulmonary invasive fungal disease after respiratory virus infection in allogeneic hematopoietic stem cell transplantation recipients. Transpl Infect Dis. 2019 Oct;21(5):e13158. doi: 10.1111/tid.13158. Epub 2019 Sep 3.
- Whimbey E, Englund JA, Couch RB. Community respiratory virus infections in immunocompromised patients with cancer. Am J Med. 1997 Mar 17;102(3A):10-8; discussion 25-6. doi: 10.1016/s0002-9343(97)80004-6.
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- COVID 19 &haematological pts
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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Klinische onderzoeken op Covid19
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Anavasi DiagnosticsNog niet aan het werven
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Ain Shams UniversityWerving
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Israel Institute for Biological Research (IIBR)Voltooid
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Hospital do CoracaoVoltooid
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Colgate PalmoliveVoltooid
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Christian von BuchwaldVoltooid
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Luye Pharma Group Ltd.Shandong Boan Biotechnology Co., LtdActief, niet wervend
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University of ZurichLabor Speiz; Swiss Armed Forces; Universitätsspital ZürichAanmelden op uitnodiging
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Alexandria UniversityVoltooid
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Henry Ford Health SystemVoltooid