Coronavirus Disease 2019NCT04403009
The Clinical Difference Between the Nonfatal Patients and the Fatal Patients With Severe COVID-19
An observational study of Coronavirus Disease 2019 and Character of the Severe Patients, run by The First Affiliated Hospital of Guangzhou Medical University at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Coronavirus Disease 2019, Character of the Severe Patients
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 1 Feb 2020to 20 Jun 2020
- 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients with Coronavirus Disease 2019
Who may be able to join
- The patients with Coronavirus Disease 2019
- Positive result on real-time reverse-transcriptase-polymerase-chain-reaction
- Positive result on chest computed tomography
Who cannot join
- No
Trial locations and contacts
2 sites in 1 country.
China2 sites
The First Affiliated Hospital of Guangzhou Medical University
Guanzhou, Guangdong, 520120
Hankou Hospital
Wuhan, Hubei, 430014
About this study
Official title: 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.
- Being tested
- no intervention
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| the nonsevere Coronavirus Disease 2019 Patients | Not described Receives: Other: no intervention | |
| the severe Coronavirus Disease 2019 Patients | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphocyte cell
the counting of Lymphocyte(counts/L)
Measured: 2 month
d-dimer
d-dimer（mg/L）
Measured: 2 month
PLT
the counting of Platelets（(counts/L)）
Measured: 2 month
CRP
the level of C-reactive protein (mg/uL)
Measured: 2 month
LDH
lactate dehydrogenase ( U/L)
Measured: 2 month
CK
creatine kinase (U/L)
Measured: 2 month
PT
prothrombin time(second)
Measured: 2 month
ALT
alanine aminotransferase(U/L)
Measured: 2 month
AST
aspartate aminotransferase(U/L)
Measured: 2 month
NK cell
natural killer cell(counts/L)
Measured: 2 month
PCT
procalcitonin（ng/ml）
Measured: 2 month
IL-6
interleukin-6(mg/L)
Measured: 2 month
Secondary outcomes (1)
the clinical difference of radiologic characteristics between the fatal patients with COVID -19 and the non fatal cases
CT scan feature
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Feb 2020
- Primary completion6 Jun 2020
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- 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
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Jianheng, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- jianheng zhang, MD, Principal investigator, First Afiliated hospital of Guangzhou medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403009
- Sponsor's protocol ID
- YLS2020(112)
- Status last verified
- Mar 2023
- First submitted
- 21 Apr 2020
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not decided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Difference Between the Nonfatal Coronavirus Disease 2019 (COVID-19) Patients and the Fatal Cases With Severe COVID-19
- ClinicalTrials.gov ID
- NCT04403009
- Acronym / sponsor ID
- YLS2020(112)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 6 Jun 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 27 May 2020 (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 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the nonsevere Coronavirus Disease 2019 Patients | – | Other: no intervention |
| the severe Coronavirus Disease 2019 Patients | – | Other: no intervention |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with Coronavirus Disease 2019
Key inclusion criteria (3 listed)
- The patients with Coronavirus Disease 2019
- Positive result on real-time reverse-transcriptase-polymerase-chain-reaction
- Positive result on chest computed tomography
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | the nonsevere Coronavirus Disease 2019 Patients, the severe Coronavirus Disease 2019 Patients |
Primary outcome
Lymphocyte cell
Time frame: 2 month
the counting of Lymphocyte(counts/L)
d-dimer
Time frame: 2 month
d-dimer（mg/L）
PLT
Time frame: 2 month
the counting of Platelets（(counts/L)）
CRP
Time frame: 2 month
the level of C-reactive protein (mg/uL)
LDH
Time frame: 2 month
lactate dehydrogenase ( U/L)
CK
Time frame: 2 month
creatine kinase (U/L)
PT
Time frame: 2 month
prothrombin time(second)
ALT
Time frame: 2 month
alanine aminotransferase(U/L)
AST
Time frame: 2 month
aspartate aminotransferase(U/L)
NK cell
Time frame: 2 month
natural killer cell(counts/L)
PCT
Time frame: 2 month
procalcitonin（ng/ml）
IL-6
Time frame: 2 month
interleukin-6(mg/L)
1 secondary outcome
the clinical difference of radiologic characteristics between the fatal patients with COVID -19 and the non fatal cases
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Individual participant dataSharing planned: Undecided. It is not decided
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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.
jianheng zhang, MD principal investigator
First Afiliated hospital of Guangzhou medical university
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Disease 2019 and Character of the Severe Patients, run by The First Affiliated Hospital of Guangzhou Medical University at 2 sites in China.
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 3 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: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lymphocyte cell (time frame: 2 month). The study lists 12 primary outcomes in all. 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 7 Mar 2023.