UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047184 |
|---|---|
| Receipt number | R000053822 |
| Scientific Title | Clinical outcomes of corticosteroids for COVID-19 patients at the National Center for Global Health and Medicine during the first wave of infection. |
| Date of disclosure of the study information | 2022/03/16 |
| Last modified on | 2022/03/16 16:38:59 |
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Basic information
Public title
Clinical outcomes of corticosteroids for COVID-19 patients at the National Center for Global Health and Medicine during the first wave of infection.
Acronym
Clinical outcomes of corticosteroids for COVID-19 patients at the National Center for Global Health and Medicine during the first wave of infection.
Scientific Title
Clinical outcomes of corticosteroids for COVID-19 patients at the National Center for Global Health and Medicine during the first wave of infection.
Scientific Title:Acronym
Clinical outcomes of corticosteroids for COVID-19 patients at the National Center for Global Health and Medicine during the first wave of infection.
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the effects of steroids in COVID-19
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improved scores for 7-category ordinary scale
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients admitted to the National Center for Global Health and Medicine Hospital with COVID-19 from February 1 to April 30, 2020
Key exclusion criteria
Cases in which corticosteroids were not used in doses consistent with ARDS or severe pneumonia
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | manabu |
| Middle name | |
| Last name | suzuki |
Organization
Center Hospital of the National Center for Global Health and Medicine
Division name
Department of Respiratory medicine
Zip code
162-8655
Address
1 Chome-21-1 Toyama, Shinjuku City, Tokyo
TEL
0332027181
msuzuki@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Chie |
| Middle name | |
| Last name | morita |
Organization
Center Hospital of the National Center for Global Health and Medicine
Division name
Department of Respiratory medicine
Zip code
162-8655
Address
1 Chome-21-1 Toyama, Shinjuku City, Tokyo
TEL
0332027181
Homepage URL
cmorita@hosp.ncgm.go.jp
Sponsor or person
Institute
Center Hospital of the National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center Hospital of the National Center for Global Health and Medicine
Address
1 Chome-21-1 Toyama, Shinjuku City, Tokyo
Tel
0332027181
none
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 | 03 | Month | 16 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S221253452100188X?dgcid=raven_sd_via_email
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S221253452100188X?dgcid=raven_sd_via_email
Number of participants that the trial has enrolled
110
Results
Between February and April 2020, 110 patients were diagnosed with COVID-19. Despite poor conditions during admission into the steroid group, there were no statistical differences in clinical course between both groups, as measured using the scale. There were no statistical differences between the two groups in the number of days to fever resolution or negative polymerase chain reaction results.
Results date posted
| 2022 | Year | 03 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We identified 110 patients diagnosed with COVID-19 between February and April 2020. The differences in patient characteristics are shown in Table 2. There were some differences in the characteristics of the patients at the time of admission. The median (range) age was 67 y in the steroid group and 46 y in the non-steroid group, with patients being significantly older in the steroid group. Hypertension was also more common in the steroid group. There were no apparent differences in sex, cardiovascular disease, diabetes, malignancy, autoimmune disease, body mass index, smoking history, or use of immunosuppressive drugs.
Participant flow
We identified 110 patients diagnosed with COVID-19 between February and April 2020.
Adverse events
Not analyzed.
Outcome measures
Between February and April 2020, 110 patients were diagnosed with COVID-19. Despite poor conditions during admission into the steroid group, there were no statistical differences in clinical course between both groups, as measured using the scale. There were no statistical differences between the two groups in the number of days to fever resolution or negative polymerase chain reaction results.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2022 | Year | 03 | Month | 16 | Day |
Last modified on
| 2022 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053822
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