UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046408 |
|---|---|
| Receipt number | R000052949 |
| Scientific Title | An exploratory study of the association between diabetes mellitus and worsening outcomes of hospitalized patients in COVID-19. |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2023/12/06 09:18:20 |
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Basic information
Public title
An exploratory study of the association between diabetes mellitus and worsening outcomes of hospitalized patients in COVID-19.
Acronym
Research on the relationship between diabetes mellitus and the prognosis of patients hospitalized with COVID-19
Scientific Title
An exploratory study of the association between diabetes mellitus and worsening outcomes of hospitalized patients in COVID-19.
Scientific Title:Acronym
ReCoDi study
Region
| Japan |
Condition
Condition
COVID-19
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the relationship between the presence of diabetes mellitus and outcome in SARS-CoV-2 infected patients hospitalized with moderate or severe criteria.
Basic objectives2
Others
Basic objectives -Others
retrospective study
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression of disease severity, introduction of ventilator management, death
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who were diagnosed as SARS-CoV-2 positive and treated in hospital
Key exclusion criteria
(1) Patients who are pregnant or breastfeeding
(2) Patients with a final diagnosis classification of "mild " during hospitalization
3) Patients admitted for the purpose of antibody cocktail therapy.
(4) Patients with malignancy.
(5) Patients who have already been diagnosed with type 1 diabetes mellitus
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Usui |
Organization
Osaki Citizen Hospital
Division name
Division of Metabolism and Diabetes
Zip code
9896183
Address
3-8-1 Furukawahonami, Osaki, Miyagi
TEL
0229-23-3311
masausui@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Usui |
Organization
Osaki Citizen Hospital
Division name
Division of Metabolism and Diabetes
Zip code
9896183
Address
3-8-1 Furukawahonami, Osaki, Miyagi
TEL
0229-23-3311
Homepage URL
masausui@med.tohoku.ac.jp
Sponsor or person
Institute
Osaki Citizen Hospital
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
Osaki city
Address
3-8-1 Furukawahonami, Osaki, Miyagi
Tel
0229-23-3311
kenshu-och@h-osaki.jp
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 | 01 | Month | 01 | 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
| 2021 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2021 | Year | 12 | Month | 17 | Day |
Last modified on
| 2023 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052949
