- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04346602
A Study on the Clinical and Psychological Characteristics of Patients With COVID-2019
April 12, 2020 updated by: Dong Yang, Jilin University
A study on the clinical and psychological characteristics of patients with coronavirus disease 2019 (COVID-2019)
Study Overview
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 Type
Observational
Enrollment (Anticipated)
132
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
-
-
Jilin
-
Chang chun, Jilin, China, 130021
- Recruiting
- The First Hospital of Jilin University
-
Sub-Investigator:
- Dong Yang, Master
-
-
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
1 year to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients with COVID-2019 would be observed.
Description
Inclusion Criteria:
- patients with COVID-2019
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patients with COVID-2019
Patients with COVID-2019 would be observed.
|
All patients with COVID-2019 would receive treatment provided by the government and should comply with relevant laws and regulations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cough
Time Frame: one month
|
Cough is one main symptom of patients with COVID-2019.
"Yes" or "no" would be recorded.
|
one month
|
|
diarrhea
Time Frame: one month
|
Diarrhea is one symptom of some patients with COVID-2019.
"Yes" or "no" would be recorded.
|
one month
|
|
anxiety
Time Frame: two months
|
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.
|
two months
|
|
insomnia
Time Frame: two months
|
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.
|
two months
|
|
depression
Time Frame: two months
|
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.
|
two months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Anticipated)
June 1, 2020
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
April 6, 2020
First Submitted That Met QC Criteria
April 12, 2020
First Posted (Actual)
April 15, 2020
Study Record Updates
Last Update Posted (Actual)
April 15, 2020
Last Update Submitted That Met QC Criteria
April 12, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 130004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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