UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050989 |
|---|---|
| Receipt number | R000058120 |
| Scientific Title | Epidemiological study on patients with COVID-19 |
| Date of disclosure of the study information | 2023/05/06 |
| Last modified on | 2024/11/03 16:36:17 |
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Basic information
Public title
Epidemiological study on patients with COVID-19
Acronym
Epidemiological study of COVID-19 patients
Scientific Title
Epidemiological study on patients with COVID-19
Scientific Title:Acronym
Epidemiological study of COVID-19 patients
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The situation of treatment and recuperation of patients infected with the new coronavirus (including hospital staff infected with the virus) will be analyzed to identify a number of obstacles and problems in order to coordinate the provision of appropriate medical care after investigating the extent of the medical crunch and its impact on medical care.
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient progress and treatment status, and issues related to the burden on fever outpatient and hospital wards, the rate of requests for hospitalization, bed utilization, and fever outpatient appointment rates.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following selection criteria will be included in the study
Patients who have a confirmed diagnosis of novel coronavirus infection by PCR or antigen test, etc., and who were treated at the Jikei University Katsushika Medical Center on an inpatient or outpatient basis, or for whom medical care was ordered (including hospital staff infected with the same virus).
(1) Patients with a medical record of any department and a record of consultation at this hospital are eligible.
(2) Patients over 18 years old and under 100 years old.
Key exclusion criteria
Persons who violate any of the following exclusion criteria will be excluded from the study
(1) Patients who have refused to participate in the study.
(2) Patients with a confirmed diagnosis at another hospital and no record of their medical history at this hospital during the period of isolation.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Seki |
Organization
The Jikei University Katsushika Medical Center
Division name
Respiratory medicine
Zip code
125-8506
Address
6-41-2, Aoto, Katsushika-ku, Tokyo 125-8506, Japam
TEL
03-3603-2111
yseki-jikd@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Seki |
Organization
The Jikei University School of Medicine
Division name
Division of Respirology, Department of Internal Medicine
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
yseki-jikd@umin.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine, Japan
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Jikei University School of Medicine
Address
Clinical Research Support Center, The Jikei University School of Medicine, 3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
Tel
03-3433-1111
rinri@jikei.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://journals.lww.com/infectdis/fulltext/2024/07000/sick_leave_and_absence_rate_of_hospital_worke
Number of participants that the trial has enrolled
1899
Results
Of the 1899 patients with confirmed COVID-19 infection, 397 (20.9%) were hospital workers. Of these 397 cases, 71, 156, and 119 hospital workers were infected in the 6th (January-March 2022), 7th (July-September 2022), and 8th (November 2022-February 2023) waves, respectively The rate of hospital worker leave due to COVID-19 infection, excluding leave due to close contact Excluding leave due to close contact, the rate was 6.3% in the 7th wave, which had the highest number of infections.
Results date posted
| 2024 | Year | 11 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 10 | Month | 31 | Day |
Other
Other related information
We will conduct a fact-finding survey of outpatient and inpatient care of patients with novel coronavirus infection (including our staff) at our hospital from January 2021 to February 2023, using thread records from electronic medical records, employment management database, and JOIN.
Management information
Registered date
| 2023 | Year | 05 | Month | 04 | Day |
Last modified on
| 2024 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058120
