Role of Lymphocyte Subsets and Laboratory Measurements in COVID-19 Disease

NCT04779359 | Unknown

• 1 other identifier: COVID-19 Disease
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

COVID-19 Disease

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients were included for this study after excluding patients \<18 years age and without confirmed diagnosis of disease.

You may qualify if:

• Confirmed diagnosis of COVID-19 disease.

You may not qualify if:

• The patients were excluded patients \<18 years age and without confirmed diagnosis of disease.

Sponsors & Collaborators

• Shanghai Public Health Clinical Center: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 8 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: • Co-Director of Shanghai Public Health Clinical Center affiliated to Fudan University

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 3, 2021
• Study Start: April 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 3, 2021

Record last verified: 2021-03