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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040211
Receipt No. R000045861
Scientific Title A Multicenter, Retrospective Study to Evaluate the Efficacy of Systemic Gluco-corticoid Against COVID-19
Date of disclosure of the study information 2020/04/21
Last modified on 2020/10/21

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Basic information
Public title A Multicenter, Retrospective Study to Evaluate the Efficacy of Systemic Gluco-corticoid Against COVID-19
Acronym DEFEAT COVID-19
Scientific Title A Multicenter, Retrospective Study to Evaluate the Efficacy of Systemic Gluco-corticoid Against COVID-19
Scientific Title:Acronym DEFEAT COVID-19
Region
Japan

Condition
Condition Novel Coronavirus Infections (COVID-19)
Classification by specialty
Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of systemic glucocorticoid administration to COVID-19 by comparing patients who received systemic glucocorticoids against COVID-19 with those who did not receive them after adjusting for propensity scores.
Basic objectives2 Others
Basic objectives -Others Various subgroup analyses will be performed to provide a detailed study of appropriate patient selection, optimal dosage, timing of initiation, and duration.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The odds ratio for improvement on a 7-point ordinal scale* on Day 15.
[*The scale is as follows: 1) Death, 2) Hospitalized, on invasive mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO), 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices, 4) Hospitalized, requiring low flow supplemental oxygen, 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise), 6) Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care, 7) Not hospitalized.]
Key secondary outcomes 1)Time to PCR negativity of the swab solution
2)Duration of heat generation
3)Percentage of improvement in imaging findings
4)Period of time until improvement in imaging findings is confirmed
5)Percentage needed/ period of time until needed/period of implementation of supplemental oxygen/ Ventilation/ECMO
6)Period of hospitalization
7)Survival period.

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 1)Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test
2)diagnosed between January 23, 2020 and May 31, 2020
3)currently hospitalized and requiring medical care for COVID-19
Key exclusion criteria 1)Requiring home oxygen therapy prior to having COVID-19
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Ogura
Organization Kanagawa Cardiovascular and Respiratory Center
Division name Department of Respiratory Medicine
Zip code 236-0051
Address 6-16-1 Tomioka-higashi, Kanazawa-ku, Yokohama-city, Kanagawa Prefecture, Japan
TEL 0457019581
Email ogura@kanagawa-junko.jp

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Ikeda
Organization Kanagawa Cardiovascular and Respiratory Center
Division name Department of Respiratory Medicine / Clinical Research Center
Zip code 2360051
Address 6-16-1 Tomioka-higashi, Kanazawa-ku, Yokohama-city, Kanagawa Prefecture, Japan
TEL 0457019581
Homepage URL
Email isatoshi0112@gmail.com

Sponsor
Institute Kanagawa Cardiovascular and Respiratory Center
Institute
Department

Funding Source
Organization Kanagawa Cardiovascular and Respiratory Center
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 Kanagawa Cardiovascular and Respiratory Center
Address 6-16-1 Tomioka-higashi, Kanazawa-ku, Yokohama-city, Kanagawa Prefecture, Japan
Tel 0457019581
Email isatoshi0112@gmail.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 1) 神奈川県立循環器呼吸器病センター 呼吸器内科(神奈川県)
2) 公立陶生病院 呼吸器内科(愛知県)
3) 神戸市立医療センター中央市民病院 呼吸器内科(兵庫県)
4) さいたま赤十字病院 呼吸器内科(埼玉県)
5) 国立国際医療研究センター病院 呼吸器内科(東京都)
6) 東京医科大学病院(東京都)
7) 東京医科歯科大学 呼吸器内科(東京都)
8) 名古屋大学医学部附属病院 呼吸器内科(愛知県)
9) 東京医療センター 呼吸器科(東京都)
10) 杏林大学 呼吸器内科/感染症科(東京都)
11) 船橋中央病院 呼吸器内科(千葉県)
12) 横須賀市民病院 呼吸器科(神奈川県)

Other administrative information
Date of disclosure of the study information
2020 Year 04 Month 21 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 No longer recruiting
Date of protocol fixation
2020 Year 04 Month 20 Day
Date of IRB
2020 Year 04 Month 21 Day
Anticipated trial start date
2020 Year 05 Month 01 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
2020 Year 06 Month 30 Day
Date trial data considered complete
2020 Year 07 Month 17 Day
Date analysis concluded
2021 Year 02 Month 28 Day

Other
Other related information Multi-center retrospective study

Management information
Registered date
2020 Year 04 Month 21 Day
Last modified on
2020 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045861

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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