Study of Lymphopenia as a Specific Biomarker or Prognostic Risk Factor for Disease Severity in Elderly Patients With COVID-19.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 227
- Locations
- 1
- Primary Endpoint
- assess the specificity of lymphopenia in COVID-19 cases in elderly people
Study Overview
Brief Summary
Background: Lymphopenia is reported to be associated with the severity of disease progression in COVID-19. Low lymphocyte count is also associated with increasing age. No study has yet investigated the effects of lymphopenia in this disease on the outcome in elderly people.
Objectives: To assess the outcome of lymphopenia in elderly patients having COVID-19 and its usefulness as prognostic factor in elderly people.
Methods: Retrospective cohort study. Clinical data (medical history, comorbidities, treatments, geriatric syndromes) and biological parameters will be collected from 100 hospitalized geriatric COVID-19 patients (> 70 yrs.) (Group 1) and 100 hospitalized geriatric patients (> 70 yrs.) presenting with acute infection other than COVID-19 (Group 2) and will be compared according to the presence/absence of lymphopenia. A third Group (3) will be studied to assess the influence of comorbidities on lymphopenia consisting of healthy aged elderly (> 70 yrs.).
Detailed Description
Introduction In December 2019 a cluster of viral pneumonia cases in Wuhan, a city in the Hubei Province of China, led to the discovery of a novel pathogen that was later named Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (1). SARS-CoV-2 rapidly spread throughout the population of China and subsequently to all continents of the world (except for Antarctica). On 11 March 2020 the outbreak was declared a pandemic by the World Health Organisation (WHO) (2). In September confirmed cases have been reported from 217 different countries and has resulted in over 27 million infected individuals and as near as 900.000 deadly cases reported to the WHO (3, 4). SARS-CoV-2 does not discriminate between social status, age or ethnicity and an effective treatment remains absent until so far. However, risk factors associated with severity of disease progression have been identified and include advanced age (>65y), comorbidities with inclusion of arterial hypertension, cardiovascular disease, cerebrovascular disease, respiratory disease and laboratory parameters such as low CD3+CD8+ T cells (<75 cells.µL-1), low lymphocyte count, neutrophil to lymphocyte ratio (N/L) (N/L ratio >3.13) and increased cardiac troponin I (≥0.05ng.mL-1) (5-9).
It has been demonstrated that both age and lymphopenia are risk factors associated with severity of disease progression in COVID-19 patients. A low lymphocyte count, however, is also known to be associated with increasing age in healthy individuals (10). Another study has also shown that a high CRP was associated with lymphopenia in a geriatric hospitalized population before the apparition of COVID-19 (11). This observation raises the question whether or not lymphopenia is a specific prognostic marker for the COVID-19 illness in elderly patients.
The aims of this study are:
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to assess the specificity of lymphopenia in COVID-19 cases in elderly people thanks to the comparison of 3 Groups:
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Group 1 consists of COVID-19 cases
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Group 2 consists of patients with an acute infection other than COVID-19
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Group 3 consists of healthy aged people defined as in the modified SENIEUR protocol
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to assess the correlation of lymphopenia in COVID-19 cases and the outcome
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to assess the relationship between other morbidities (such as CV diseases / risk factors) and lymphopenia in elderly people.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Cfr definition of the three groups
Exclusion Criteria
- •Patients receiving immunosuppressive therapy, patients with known active cancer or hematologic disorders, patients undergoing radio- or chemotherapy or with known autoimmune diseases will not be included since these underlying conditions or therapies can interfere with white blood cell count in a way that is beyond the scope of this research.
Outcomes
Primary Outcomes
assess the specificity of lymphopenia in COVID-19 cases in elderly people
Time Frame: 3 years
to assess the specificity of lymphopenia in COVID-19 cases in elderly people, thanks to the comparison of 3 Groups: 1. Group 1 consists of COVID-19 cases 2. Group 2 consists of patients with an acute infection other than COVID-19 3. Group 3 consists of healthy aged people defined as in the modified SENIEUR protocol
Secondary Outcomes
- to assess the relationship between other morbidities (such as CV diseases / risk factors) and lymphopenia in elderly people.(3 years)
- to assess the correlation of lymphopenia in COVID-19 cases and the outcome(3 years)
Investigators
Nathalie compté
Clinic head of geriatric unit
Universitair Ziekenhuis Brussel