Clinical trial NCT04930731: Risk Factors and Characteristics of COVID 19 Infection in Patients With Haematological Diseases
Official title: Risk Factors and Characteristics of COVID 19 Infection in Patients With Haematological Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: Haematological diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 2 groups Group A control group Group B study group

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Risk Factors and Characteristics of COVID 19 infection in Patients with Haematological Diseases
timeFrame: From September 2021 to June 2022
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: safaakhaled2003@gmail.com
name: Safaa A Ahmed
role: STUDY_CHAIR
References:
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