COVID-19 DiseaseNCT04779359
Role of Lymphocyte Subsets and Laboratory Measurements in COVID-19 Disease
An observational study of COVID-19 Disease, run by Shanghai Public Health Clinical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Disease
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to Dec 2021
- How long will I take part?
- 8 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients were included for this study after excluding patients <18 years age and without confirmed diagnosis of disease.
Who may be able to join
- Confirmed diagnosis of COVID-19 disease.
Who cannot join
- The patients were excluded patients <18 years age and without confirmed diagnosis of disease.
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19 Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2021.02-2021.08
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study startApr 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1 participants (estimated)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Shanghai Public Health Clinical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hongzhou Lu, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779359
- Sponsor's protocol ID
- COVID-19 Disease
- Status last verified
- Mar 2021
- First submitted
- 1 Mar 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Role of Lymphocyte Subsets and Laboratory Measurements in COVID-19 Disease- A Retrospective Study
- ClinicalTrials.gov ID
- NCT04779359
- Acronym / sponsor ID
- COVID-19 Disease
- Conditions
- COVID-19 Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Shanghai Public Health Clinical CenterOther government
- Study start
- Apr 2021 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 8 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients were included for this study after excluding patients <18 years age and without confirmed diagnosis of disease.
Key inclusion criteria (1 listed)
- Confirmed diagnosis of COVID-19 disease.
Key exclusion criteria (1 listed)
- The patients were excluded patients <18 years age and without confirmed diagnosis of disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Disease, run by Shanghai Public Health Clinical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of CD4+ and CD8+ T cell absolute counts to disease outcomes (time frame: 2021.02-2021.08). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.