UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040211 |
|---|---|
| Receipt number | 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 | 2022/10/24 08:43:46 |
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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
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
isatoshi0112@gmail.com
Sponsor or person
Institute
Kanagawa Cardiovascular and Respiratory Center
Institute
Department
Personal name
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
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
https://www.nature.com/articles/s41598-021-90246-y
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-021-90246-y
Number of participants that the trial has enrolled
1092
Results
The odds of improvement in a 7-point ordinal score on Day 15 was significantly lower for the corticosteroid versus non-corticosteroid group. The time to improvement in radiological findings was significantly shorter in the corticosteroid. The duration of invasive mechanical ventilation was shorter in corticosteroid group. Of the 106 patients who received methylprednisolone, the duration of invasive mechanical ventilation was significantly shorter in the pulse/semi-pulse group.
Results date posted
| 2022 | Year | 10 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 05 | Month | 21 | Day |
Baseline Characteristics
Of 1092 COVID-19 patients analyzed, 118 patients were assigned to either the corticosteroid and non-corticosteroid group, after propensity score matching. At baseline, most patients did not require invasive/noninvasive ventilation (85.6% corticosteroid group vs. 89.8% non-corticosteroid group).
Participant flow
This multicenter, retrospective study enrolled consecutive hospitalized COVID-19 patients diagnosed January to April 2020 across 30 institutions in Japan. Clinical outcomes were compared for COVID-19 patients who received or did not receive corticosteroids, after adjusting for propensity scores.
Adverse events
Difficult to evaluate due to retrospective study
Outcome measures
The primary endpoint was the odds ratio (OR) for improvement on a 7-point ordinal score on Day 15.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2022 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045861
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