COVID-2019NCT04346602
A Study on the Clinical and Psychological Characteristics of Patients With COVID-2019
An observational study of COVID-2019, run by Jilin University at 1 site in China.
Trial summary
A study on the clinical and psychological characteristics of patients with coronavirus disease 2019 (COVID-2019) Read more about this study
- Who is it for?
- Ages 1 year to 80 years
- Conditions the study is for
- COVID-2019
- What is being tested?
- all treatment about COVID-2019
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 1 Dec 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 1 year to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with COVID-2019 would be observed.
Who may be able to join
- patients with COVID-2019
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Hospital of Jilin University
Changchun, Jilin, 130021
Dong Yang, Master
Dong Yang, Master
About this study
A study on the clinical and psychological characteristics of patients with coronavirus disease 2019 (COVID-2019)
Read the detailed description
The main objective of this study is to study the clinical and psychological responses of patients with COVID-2019 during the whole treatment process. Including clinical symptoms, auxiliary examination results, and corresponding psychological changes, including depression, anxiety, insomnia, etc. This study will draw lessons about treatment and other better advices for other countries and regions.
- Conditions
- COVID-2019
- Being tested
- all treatment about COVID-2019
- Keywords
- COVID-2019, clinical, psychological, symptom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
all treatment about COVID-2019Other
All patients with COVID-2019 would receive treatment provided by the government and should comply with relevant laws and regulations.
| Study group | Role | What they receive |
|---|---|---|
| patients with COVID-2019 | Patients with COVID-2019 would be observed. Receives: Other: all treatment about COVID-2019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
fever
The fever is one main clinical characteristics of patients with COVID-2019, Measured by thermometer. 37.2-38 degrees Celsius, low fever; 38-39 degrees Celsius, moderate fever; 39-40 degrees Celsius, high fever.
Measured: one month
Secondary outcomes (5)
cough
Cough is one main symptom of patients with COVID-2019. "Yes" or "no" would be recorded.
Measured: one month
diarrhea
Diarrhea is one symptom of some patients with COVID-2019. "Yes" or "no" would be recorded.
Measured: one month
anxiety
Anxiety is one main psychological characteristic of patients with COVID-2019. It would be assessed by Hamilton anxiety scale (HAMA). Scores of HAMA were positively correlated with the severity of anxiety.
Measured: two months
insomnia
Insomnia is one main psychological characteristic of patients with COVID-2019. It would be assessed by Athens insomnia scale (AIS). Scores of AIS were positively correlated with the severity of insomnia.
Measured: two months
depression
Depression is one psychological characteristic of patients with COVID-2019.It would be assessed by Hamilton Depression Rating Scale (HAMD) . Scores of HAMD were positively correlated with the severity of depression.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start1 Feb 2020
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-2019Studies 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
- Prospective
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Yang, Jilin University
- Investigators
- Dong Yang, Master, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346602
- Sponsor's protocol ID
- 130004
- Status last verified
- Apr 2020
- First submitted
- 6 Apr 2020
- Last updated
- 15 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yan B, Song L, Guo J, Wang Y, Peng L, Li D. Association Between Clinical Characteristics and Short-Term Outcomes in Adult Male COVID-19 Patients With Mild Clinical Symptoms: A Single-Center Observational Study. Front Med (Lausanne). 2021 Jan 5;7:571396. doi: 10.3389/fmed.2020.571396. eCollection 2020.
PubMed 33469542
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Clinical and Psychological Characteristics of Patients With COVID-2019
- ClinicalTrials.gov ID
- NCT04346602
- Acronym / sponsor ID
- 130004
- Conditions
- COVID-2019
- Keywords
- COVID-2019, clinical, psychological, symptom
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Jilin UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 15 Apr 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.
A study on the clinical and psychological characteristics of patients with coronavirus disease 2019 (COVID-2019)
Detailed description
The main objective of this study is to study the clinical and psychological responses of patients with COVID-2019 during the whole treatment process. Including clinical symptoms, auxiliary examination results, and corresponding psychological changes, including depression, anxiety, insomnia, etc. This study will draw lessons about treatment and other better advices for other countries and regions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with COVID-2019 | – | Other: all treatment about COVID-2019Patients with COVID-2019 would be observed. |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with COVID-2019 would be observed.
Key inclusion criteria (1 listed)
- patients with COVID-2019
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 |
|---|---|---|
| all treatment about COVID-2019All patients with COVID-2019 would receive treatment provided by the government and should comply with relevant laws and regulations. | Other | patients with COVID-2019 |
Primary outcome
fever
Time frame: one month
The fever is one main clinical characteristics of patients with COVID-2019, Measured by thermometer. 37.2-38 degrees Celsius, low fever; 38-39 degrees Celsius, moderate fever; 39-40 degrees Celsius, high fever.
5 secondary outcomes
cough
Time frame: one month
diarrhea
Time frame: one month
anxiety
Time frame: two months
insomnia
Time frame: two months
depression
Time frame: two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Derived from this study: PubMed 33469542Yan B, Song L, Guo J, Wang Y, Peng L, Li D. Association Between Clinical Characteristics and Short-Term Outcomes in Adult Male COVID-19 Patients With Mild Clinical Symptoms: A Single-Center Observational Study. Front Med (Lausanne). 2021 Jan 5;7:571396. doi: 10.3389/fmed.2020.571396. eCollection 2020.
- Individual participant dataSharing planned: No
Related trials for COVID-2019
RecruitingObservational study
COVID-2019 Vaccine Immune Response Base on Single Cell Multi-Omics
Immune System and Related Disorders
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.
Dong Yang, Master principal investigator
The First Hospital of Jilin University
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 COVID-2019, run by Jilin University 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 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 15 Apr 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?
Contact Bai ling Yan, Doctor (15804300278, yanbailing@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fever (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04346602, which also lists 1 linked publication.
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 15 Apr 2020.