UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049446 |
|---|---|
| Receipt number | R000056303 |
| Scientific Title | Survey about impact of COVID-19 symptoms on daily life and labor productivity |
| Date of disclosure of the study information | 2022/11/08 |
| Last modified on | 2023/09/25 18:27:51 |
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Basic information
Public title
Survey about impact of COVID-19 symptoms on daily life and labor productivity
Acronym
Survey about impact of COVID-19 symptoms on daily life and labor productivity
Scientific Title
Survey about impact of COVID-19 symptoms on daily life and labor productivity
Scientific Title:Acronym
Survey about impact of COVID-19 symptoms on daily life and labor productivity
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To characterize COVID-19 patients who require an antiviral treatment at home or accommodation by surveying the clinical feature, clinical course, and impact on daily and social life of COVID-19 symptoms.
Basic objectives2
Others
Basic objectives -Others
Aggregate and analyze the results of COVID-19 web survey.
COVID-19 survey items
1)Symptoms, severity of symptoms, duration of symptoms
2)Impact on social and daily life by symptoms
3)Time until work/study/housework can be done
4)Importance of early COVID-19 symptoms disappearance
5)Importance of prevention of the transmission of SARS-CoV-2 to contacts
6)Importance of earlier test negative for SARS-CoV-2
7)Anxiety/fear with risk of household transmission, death, sequelae
8)Satisfaction with the treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Outcomes for COVID-19 survey items
1)Symptoms, severity of symptoms, duration of symptoms
2)Impact on social and daily life by symptoms
3)Time until work/study/housework resuming
4)Importance of early COVID-19 symptoms disappearance
5)Importance of prevention of the transmission of SARS-CoV-2 to contacts
6)Importance of earlier test negative for SARS-CoV-2
7)Anxiety/fear with risk of household transmission, death, sequelae
8)Satisfaction with the treatment
Key secondary outcomes
Outcomes for post-acute COVID-19 syndrome survey items
1)Symptoms, severity of symptoms, duration of symptoms
2)Impact on social and daily life by symptoms
3)Time until work/study/housework can be done
4)Impact on work/school/housework productivity
5)Changes in the work environment (changes in work content, leave of absence, retirement, job change)
6)Anxiety/fear with post-acute COVID-19 syndrome
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Those who were diagnosed with COVID-19 during April to August 2022 and had symptoms
2)Those who were treated at home or accommodation
Key exclusion criteria
Those who do not consent to this survey
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Yamato |
Organization
Rinku General Medical Center
Division name
Division of General Internal Medicine and Infectious Diseases Center for Infectious Diseases
Zip code
598-8577
Address
2-23 Rinku Ourai-Kita, Izumisano, Osaka 598-8577, Japan
TEL
072-469-3111
m-yamato@rgmc.izumisano.osaka.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Tanaka |
Organization
Shionogi & Co., Ltd.
Division name
Medical Affairs Department
Zip code
100-0005
Address
1-8-2, Marunouchi, Chiyoda-ku, Tokyo 100-0005, Japan
TEL
080-2409-3174
Homepage URL
shintarou.tanaka@shionogi.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
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
Non-Profit Organization MINS Research Ethics Committee
Address
5-20-9-401, Mita, Minato-ku, Tokyo, Japan
Tel
03-6416-1868
npo-mins@j-irb.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
| 2022 | Year | 11 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
2000
Results
The patient-reported symptoms and those impact on daily lives in acute and post-quarantine period were similar regardless of presence/absence of risk factors for severe disease. This may suggest an appropriate treatment is needed not only patients with risk factors but also patient without risk factors.
Results date posted
| 2023 | Year | 09 | Month | 25 | 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
| 2022 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 11 | Month | 07 | Day |
Last modified on
| 2023 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056303
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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