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

March 1, 2021 updated by: Hongzhou Lu, Shanghai Public Health Clinical Center

The Predictive Role of Lymphocyte Subsets and Laboratory Measurements in COVID-19 Disease- A Retrospective Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of CD4+ and CD8+ T cell absolute counts to disease outcomes
Time Frame: 2021.02-2021.08
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Public Health Clinical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

March 1, 2021

First Posted (Actual)

March 3, 2021

Study Record Updates

Last Update Posted (Actual)

March 3, 2021

Last Update Submitted That Met QC Criteria

March 1, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-19 Disease

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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