UMIN-CTR Clinical Trial

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
Email	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
Email	cmorita@hosp.ncgm.go.jp

Sponsor
Institute	Center Hospital of the National Center for Global Health and Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053822