Covid19 Clinical Trial
Official title:
Study of Lymphopenia as a Specific Biomarker or Prognostic Risk Factor for Disease Severity in Elderly Patients With COVID-19.
NCT number | NCT04800731 |
Other study ID # | Lymfopenia |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 30, 2021 |
Est. completion date | June 30, 2022 |
Verified date | January 2023 |
Source | Universitair Ziekenhuis Brussel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.).
Status | Completed |
Enrollment | 227 |
Est. completion date | June 30, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 70 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ brussel | Brussel |
Lead Sponsor | Collaborator |
---|---|
Universitair Ziekenhuis Brussel |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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:
Group 1 consists of COVID-19 cases Group 2 consists of patients with an acute infection other than COVID-19 Group 3 consists of healthy aged people defined as in the modified SENIEUR protocol |
3 years | |
Secondary | to assess the correlation of lymphopenia in COVID-19 cases and the outcome | 2) to assess the correlation of lymphopenia in COVID-19 cases and the outcome, we will compare the group number 1 with the group number 2 | 3 years | |
Secondary | to assess the relationship between other morbidities (such as CV diseases / risk factors) and lymphopenia in elderly people. | to assess the specificity of lymphopenia in COVID-19 cases in elderly people, thanks to the comparison of 3 Groups:
Group 1 consists of COVID-19 cases Group 2 consists of patients with an acute infection other than COVID-19 Group 3 consists of healthy aged people defined as in the modified SENIEUR protocol |
3 years |
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