Risk Factors and Characteristics of COVID 19 Infection in Patients With Haematological Diseases

NCT ID: NCT04930731

Last Updated: 2021-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-30

Study Completion Date

2022-09-30

Brief Summary

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1. assessment of risk factor of covid 19 in haematological patients
2. assessment of characteristics of covid 19 in haematological patients

Detailed Description

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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.

Conditions

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ayah Ibrahim Nemr

Resident doctor at haematology unit ,, internal medicine department ,, assiut university

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Safaa A Ahmed

Role: STUDY_CHAIR

[email protected]

Central Contacts

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Aya Nemr, Master

Role: CONTACT

0201097069179

Essam E Mohamed

Role: CONTACT

0201001971906

References

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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.

Reference Type BACKGROUND
PMID: 25344526 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29571669 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16974212 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31402532 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10868137 (View on PubMed)

Other Identifiers

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COVID 19 &haematological pts

Identifier Type: -

Identifier Source: org_study_id

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