- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04403009
The Clinical Difference Between the Nonfatal Patients and the Fatal Patients With Severe COVID-19
March 4, 2023 updated by: Zhang Jianheng, The First Affiliated Hospital of Guangzhou Medical University
The Clinical Difference Between the Nonfatal Coronavirus Disease 2019 (COVID-19) Patients and the Fatal Cases With Severe COVID-19
To investigate the difference of the difference between the nonfatal Coronavirus Disease 2019 (COVID-19) Patients and the fatal Patients .The cross sectional study was undertaken to compare the clinical information (laboratory and radiologic characteristics)of nonfatal participants and fatal cases.
The investigators wish figure out the clinical character of the fatal participants.
The result may help the physician to find the fatal patients with COVID-19 more easily.
The fatal patients with COVID-19 could be treated early.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guanzhou, Guangdong, China, 520120
- The First Affiliated Hospital of Guangzhou Medical University
-
-
Hubei
-
Wuhan, Hubei, China, 430014
- Hankou Hospital
-
-
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
20 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The patients with Coronavirus Disease 2019
Description
Inclusion Criteria:
- The patients with Coronavirus Disease 2019
- Positive result on real-time reverse-transcriptase-polymerase-chain-reaction
- Positive result on chest computed tomography
Exclusion Criteria:
- No
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
the nonsevere Coronavirus Disease 2019 Patients
|
no intervention
|
|
the severe Coronavirus Disease 2019 Patients
|
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lymphocyte cell
Time Frame: 2 month
|
the counting of Lymphocyte(counts/L)
|
2 month
|
|
d-dimer
Time Frame: 2 month
|
d-dimer(mg/L)
|
2 month
|
|
PLT
Time Frame: 2 month
|
the counting of Platelets((counts/L))
|
2 month
|
|
CRP
Time Frame: 2 month
|
the level of C-reactive protein (mg/uL)
|
2 month
|
|
LDH
Time Frame: 2 month
|
lactate dehydrogenase ( U/L)
|
2 month
|
|
CK
Time Frame: 2 month
|
creatine kinase (U/L)
|
2 month
|
|
PT
Time Frame: 2 month
|
prothrombin time(second)
|
2 month
|
|
ALT
Time Frame: 2 month
|
alanine aminotransferase(U/L)
|
2 month
|
|
AST
Time Frame: 2 month
|
aspartate aminotransferase(U/L)
|
2 month
|
|
NK cell
Time Frame: 2 month
|
natural killer cell(counts/L)
|
2 month
|
|
PCT
Time Frame: 2 month
|
procalcitonin(ng/ml)
|
2 month
|
|
IL-6
Time Frame: 2 month
|
interleukin-6(mg/L)
|
2 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the clinical difference of radiologic characteristics between the fatal patients with COVID -19 and the non fatal cases
Time Frame: 2 months
|
CT scan feature
|
2 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SPO2
Time Frame: 2 month
|
oxygen Saturation
|
2 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: jianheng zhang, MD, First Afiliated hospital of Guangzhou medical university
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 (Actual)
February 1, 2020
Primary Completion (Actual)
June 6, 2020
Study Completion (Actual)
June 20, 2020
Study Registration Dates
First Submitted
April 21, 2020
First Submitted That Met QC Criteria
May 24, 2020
First Posted (Actual)
May 27, 2020
Study Record Updates
Last Update Posted (Estimate)
March 7, 2023
Last Update Submitted That Met QC Criteria
March 4, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YLS2020(112)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
It is not decided
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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