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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04779359
Other study ID # COVID-19 Disease
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2021
Est. completion date December 2021

Study information

Verified date March 2021
Source Shanghai Public Health Clinical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To investigate the predictive role of lymphocyte subsets and other laboratory measurements in adult patients with COVID-19.This was a single center, retrospective study that involved adult patients with confirmed diagnosis of COVID-19. Electronic medical records were reviewed. Data including age, sex, symptom from onset to hospital admission and laboratory findings at admission of hospitalized patients with confirmed COVID-19 were extracted and analyzed retrospectively.This study indicates that the levels of lymphocyte subsets (CD4+, and CD8+) are associated with disease progression and severity, along with prognosis in patients with COVID-19.


Description:

This was a single center, retrospective study that involved adult patients with confirmed diagnosis of COVID-19. Electronic medical records were reviewed. Data including age, sex, symptom from onset to hospital admission and laboratory findings at admission of hospitalized patients with confirmed COVID-19 were extracted and analyzed retrospectively. Identifying the possible immune factors and laboratory parameters is requisite for the early identification of patients with severe COVID-19 and timely intervention for control of the disease. There is an unmet need to establish robust clinical cutoffs of lymphocyte subsets for predicting risk associated with ICU admission, mechanical ventilation, and mortality in COVID-19 patients. This retrospective study was thus carried out to improve knowledge and clinical utility of lymphocyte subset measurements, together with other laboratory measurements and clinical information, for understanding prognosis in COVID-19 patients. These findings suggest that alterations in lymphocyte subsets and laboratory measurements play a significant role in the progression of COVID-19.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1
Est. completion date December 2021
Est. primary completion date August 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Confirmed diagnosis of COVID-19 disease. Exclusion Criteria: - The patients were excluded patients <18 years age and without confirmed diagnosis of disease.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Public Health Clinical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation of CD4+ and CD8+ T cell absolute counts to disease outcomes The study endpoints were to demonstrate whether CD4+ and CD8+ T cell absolute counts are prognostic marker in determining disease outcomes (including ICU admission and/or mechanical ventilation and/or mortality); to explore whether lymphocyte subset measurements recover at hospital discharge or in convalescence; lymphocyte subset measurements between severe and non-severe groups, at admission. In addition, association between CD4+ and CD8+ T cell absolute counts with cytokine levels and other laboratory parameters (neutrophil counts, total lymphocyte counts, platelet counts, C-reactive protein levels) were also assessed. 2021.02-2021.08
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