Pneumonia Caused by Human Coronavirus2019-nCoVNCT04292327
Clinical Progressive Characteristics and Treatment Effects of 2019-novel Coronavirus
An observational study of Pneumonia Caused by Human Coronavirus, run by Fujian Provincial Hospital at 1 site in China.
Trial summary
Objects: The purpose of this study was to observe the characteristics of morbidity, disease progression and therapeutic effects of 2019-novel coronavirus pneumonia patients with different clinical types. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pneumonia Caused by Human Coronavirus
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Jul 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Collect COVID-19 patients admitted to Wuhan Infectious Diseases Hospital (Wuhan JinYinTan Hospital) from January 2020 to March 2020
Who may be able to join
- 2019-nCov (SARA-Cov-2) nucleic acid positive detected by PCR.
- Older than 18 years old and younger than 75 years old.
- Meet the diagnostic criteria of COVID-19 for different types (including ordinary type, heavy type and critical type)
Who cannot join
- the age is less than 18 years old;
- pregnant or lactating women;
- severe underlying diseases, such as advanced malignant tumor, end-stage lung disease, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Progressive Characteristics and Treatment Effects of 2019-novel Coronavirus(2019-nCoV)
Objects: The purpose of this study was to observe the characteristics of morbidity, disease progression and therapeutic effects of 2019-novel coronavirus pneumonia patients with different clinical types.
Method: A single center, retrospective and observational study was used to collect COVID-19 patients admitted to Wuhan Infectious Diseases Hospital (Wuhan JinYinTan Hospital) from January 2020 to March 2020. The general information, first clinical symptoms, hospitalization days, laboratory examination, CT examination, antiviral drugs, immune enhancers, traditional Chinese medicine treatment and other clinical intervention measures were recorded, and the nutritional status and prognosis of the patients were recorded. confirm COVID-19 's disease progression, clinical characteristics, disease severity and treatment effects. To compare the characteristics of disease progression, clinical features, disease severity and therapeutic effect of different types of COVID-19.
Read more
Outcomes: The characteristics of disease progression, clinical features, disease severity and therapeutic effect of different types of COVID-19.
Conclusion: The characteristics of disease progression, clinical features and therapeutic effect of different types of COVID-19.
Read the detailed description
Since December 2019, patients with unexplained pneumonia have appeared in some medical institutions in Wuhan, China. Nucleic acid testing was completed on January 10, 2020, which was confirmed to be caused by 2019-novel coronavirus. In 2020, the World Health Organization(WHO) named the virus 2019-novel coronavirus(2019-nCoV). The WHO announced that the pneumonia caused by 2019-nCoV is officially called COVID-19. Today, more than 70,000 cases have been confirmed and more than 2,000 patients have died.
At present, the epidemiological characteristics, laboratory indicators, imaging features and clinical treatment effects of COVID-19 should be reported, but the sample size is small. Large sample studies are still needed to further confirm COVID-19 's disease progression, clinical characteristics, disease severity and treatment effects, so as to provide a scientific basis for future clinical treatment. Therefore, it is particularly important to further review the relationship between the characteristics and prognosis of such patients.
- Conditions
- Pneumonia Caused by Human Coronavirus
- Keywords
- 2019-novel coronavirus, Pneumonia
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The ordinary COVID-19 | Consistent with the diagnosis of ordinary COVID-19. | |
| The heavy COVID-19. | Consistent with the diagnosis of heavy COVID-19. | |
| The critical COVID-19 | Consistent with the diagnosis of critical COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
The mortality of COVID-19 in 28 days
Measured: 28 day
The time interval of Nucleic acid detection become negative
The time interval of COVID-19 form nucleic acid confirmed to the nucleic acid detection turn into negative.
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Jan 2020
- Primary completion30 Apr 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia Caused by Human CoronavirusStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuling Shang, Fujian Provincial Hospital
- Investigators
- Xiuling Shang, Principal investigator, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292327
- Sponsor's protocol ID
- KY-2020-24.01
- Acronym
- 2019-nCoV
- Status last verified
- Feb 2020
- First submitted
- 23 Feb 2020
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Progressive Characteristics and Treatment Effects of 2019-novel Coronavirus(2019-nCoV)
- ClinicalTrials.gov ID
- NCT04292327
- Acronym / sponsor ID
- 2019-nCoV / KY-2020-24.01
- Conditions
- Pneumonia Caused by Human Coronavirus
- Keywords
- 2019-novel coronavirus, Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 3 Mar 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.
Objects: The purpose of this study was to observe the characteristics of morbidity, disease progression and therapeutic effects of 2019-novel coronavirus pneumonia patients with different clinical types.
Method: A single center, retrospective and observational study was used to collect COVID-19 patients admitted to Wuhan Infectious Diseases Hospital (Wuhan JinYinTan Hospital) from January 2020 to March 2020. The general information, first clinical symptoms, hospitalization days, laboratory examination, CT examination, antiviral drugs, immune enhancers, traditional Chinese medicine treatment and other clinical intervention measures were recorded, and the nutritional status and prognosis of the patients were recorded. confirm COVID-19 's disease progression, clinical characteristics, disease severity and treatment effects. To compare the characteristics of disease progression, clinical features, disease severity and therapeutic effect of different types of COVID-19.
Outcomes: The characteristics of disease progression, clinical features, disease severity and therapeutic effect of different types of COVID-19.
Conclusion: The characteristics of disease progression, clinical features and therapeutic effect of different types of COVID-19.
Detailed description
Since December 2019, patients with unexplained pneumonia have appeared in some medical institutions in Wuhan, China. Nucleic acid testing was completed on January 10, 2020, which was confirmed to be caused by 2019-novel coronavirus. In 2020, the World Health Organization(WHO) named the virus 2019-novel coronavirus(2019-nCoV). The WHO announced that the pneumonia caused by 2019-nCoV is officially called COVID-19. Today, more than 70,000 cases have been confirmed and more than 2,000 patients have died.
At present, the epidemiological characteristics, laboratory indicators, imaging features and clinical treatment effects of COVID-19 should be reported, but the sample size is small. Large sample studies are still needed to further confirm COVID-19 's disease progression, clinical characteristics, disease severity and treatment effects, so as to provide a scientific basis for future clinical treatment. Therefore, it is particularly important to further review the relationship between the characteristics and prognosis of such patients.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The ordinary COVID-19 | – | –Consistent with the diagnosis of ordinary COVID-19. |
| The heavy COVID-19. | – | –Consistent with the diagnosis of heavy COVID-19. |
| The critical COVID-19 | – | –Consistent with the diagnosis of critical COVID-19 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Collect COVID-19 patients admitted to Wuhan Infectious Diseases Hospital (Wuhan JinYinTan Hospital) from January 2020 to March 2020
Key inclusion criteria (3 listed)
- 2019-nCov (SARA-Cov-2) nucleic acid positive detected by PCR.
- Older than 18 years old and younger than 75 years old.
- Meet the diagnostic criteria of COVID-19 for different types (including ordinary type, heavy type and critical type)
Key exclusion criteria (3 listed)
- the age is less than 18 years old;
- pregnant or lactating women;
- severe underlying diseases, such as advanced malignant tumor, end-stage lung disease, etc.
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
Mortality
Time frame: 28 day
The mortality of COVID-19 in 28 days
The time interval of Nucleic acid detection become negative
Time frame: 28 day
The time interval of COVID-19 form nucleic acid confirmed to the nucleic acid detection turn into negative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Pneumonia Caused by Human Coronavirus
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.
Xiuling Shang principal investigator
Fujian Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia Caused by Human Coronavirus, run by Fujian Provincial Hospital at 1 site 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 3 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 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Mortality (time frame: 28 day). The study lists 2 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 3 Mar 2020.