UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056046 |
|---|---|
| Receipt number | R000061335 |
| Scientific Title | Observational study of symptoms and their course in COVID-19 affected patients |
| Date of disclosure of the study information | 2024/11/05 |
| Last modified on | 2025/09/16 13:27:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Observational study of symptoms and their course in COVID-19 patients
Acronym
Observational study of symptoms and their course in COVID-19 affected patients
Scientific Title
Observational study of symptoms and their course in COVID-19 affected patients
Scientific Title:Acronym
Observational study of symptoms and their course in COVID-19 affected patients
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of SARS-CoV-2 clinical course
Basic objectives2
Others
Basic objectives -Others
Investigation of SARS-CoV-2 residuals after COVID-19 treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Virus detection rate by virus culture at day5 and/or day10 after treatment.
Key secondary outcomes
Base
Study type
Observational
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed as COVID-19 with a rapid antigen detection kit
Key exclusion criteria
None
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | masahiro |
| Middle name | |
| Last name | sugawara |
Organization
Japan Physicians Association
Division name
none
Zip code
101-0062
Address
2-5 Tokyo Medical Association Bld. Kandasurugadai, Chiyoda-ku, Tokyo.
TEL
03-3259-6111
jpa@nichirinnai.jp
Public contact
Name of contact person
| 1st name | chigusa |
| Middle name | |
| Last name | iwasaki |
Organization
RIcerca clinica Co.,Ltd
Division name
clinical support center
Zip code
812-0013
Address
2-18-30 Yaesuhakata Bld. 6F, Hakataeki Higashi, Hakata-ku, Fukuoka city, Fukuoka.
TEL
092-435-1150
Homepage URL
secretary@ricercaclinica.jp
Sponsor or person
Institute
Japan Physicians Association Influenza Study Group
Institute
Department
Personal name
Funding Source
Organization
SHIONOGI & CO.,LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Haradoi Hospital
Address
6-40-8, Aoba, Higashi-ku, Fukuoka city, Fukuoka.
Tel
0120-372-891
irb@haradoi-hospital.com
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
| 2024 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
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 | 09 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not specific
Management information
Registered date
| 2024 | Year | 11 | Month | 05 | Day |
Last modified on
| 2025 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061335
