Study of Lymphopenia as a Specific Biomarker or Prognostic Risk Factor for Disease Severity in Elderly Patients With COVID-19
1 other identifier
observational
227
1 country
1
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.).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2021
CompletedFirst Posted
Study publicly available on registry
March 16, 2021
CompletedStudy Start
First participant enrolled
June 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedJanuary 31, 2023
January 1, 2023
1 year
March 11, 2021
January 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
assess the specificity of lymphopenia in COVID-19 cases in elderly people
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
3 years
Secondary Outcomes (2)
to assess the correlation of lymphopenia in COVID-19 cases and the outcome
3 years
to assess the relationship between other morbidities (such as CV diseases / risk factors) and lymphopenia in elderly people.
3 years
Study Arms (3)
Group 1
Group 1 will consist of 100 patients COVID-19 positive patients older than 70 years old hospitalized in UZ Brussel from February 2020 until September 2020 with a positive RT-PCR test for SARS-CoV-2.
Group 2
Group 2 will consist of 100 patients older than 70 years old hospitalized in UZ Brussel for acute infections other than COVID-19.
Group 3
Group 3 will consist of healthy aged people defined as in the modified SENIEUR protocol (12, 13). This group is recruited from a previously conducted study. These are community dwelling individuals above the age of 70 and considered as almost healthy with some conditions that are present in the majority of old people such as osteoporosis, osteoarthritis or atherosclerosis.
Interventions
Eligibility Criteria
Group 1 will consist of 100 patients COVID-19 positive patients older than 70 years old hospitalized in UZ Brussel from February 2020 until September 2020 with a positive RT-PCR test for SARS-CoV-2. Group 2 will consist of 100 patients older than 70 years old hospitalized in UZ Brussel for acute infections other than COVID-19. To assess the influence of comorbidities on lymphopenia in elderly people, the Groups 1 and 2 will be compared to a well-defined historical group (Group 3): Group 3 will consist of healthy aged people defined as in the modified SENIEUR protocol (12, 13). This group is recruited from a previously conducted study. These are community dwelling individuals above the age of 70 and considered as almost healthy with some conditions that are present in the majority of old people such as osteoporosis, osteoarthritis or atherosclerosis.
You may qualify if:
- Cfr definition of the three groups
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ brussel
Brussels, 1090, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinic head of geriatric unit
Study Record Dates
First Submitted
March 11, 2021
First Posted
March 16, 2021
Study Start
June 30, 2021
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
January 31, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share
There is no sharing plan