UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050188 |
|---|---|
| Receipt number | R000057165 |
| Scientific Title | Risk factors for the development of pneumonia in schizophrenia patients infected with COVID-19 |
| Date of disclosure of the study information | 2023/02/01 |
| Last modified on | 2023/08/11 13:16:11 |
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Basic information
Public title
Risk factors for the development of pneumonia in schizophrenia patients infected with COVID-19
Acronym
Risk factors for the development of pneumonia in schizophrenia patients infected with COVID-19
Scientific Title
Risk factors for the development of pneumonia in schizophrenia patients infected with COVID-19
Scientific Title:Acronym
Risk factors for the development of pneumonia in schizophrenia patients infected with COVID-19
Region
| Japan |
Condition
Condition
Schizophrenia patient infected with COVID-19
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the association between psychotropic medications and risk of pneumonia due to COVID-19 in patients with schizophrenia
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between psychotropic medication (antipsychotics, benzodiazepines, mood stabilizers) taken during COVID-19 infection and development of pneumonia
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with schizophrenia and schizoaffective disorder (DSM-5) admitted to Kurita Hospital who were infected with COVID-19 in 2022.
Key exclusion criteria
Patients with comorbidities of malignancy, cerebrovascular disease, cardiovascular disease, chronic kidney disease, and epilepsy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Arai |
Organization
Kurita hospital
Division name
Department of Psychiatry
Zip code
3800921
Address
695 Kurita, Nagano City, Nagano Prefecture
TEL
026-226-1311
soundofdistiny@icloud.com
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Arai |
Organization
Kurita hospital
Division name
Department of Psychiatry
Zip code
380-0921
Address
695 Kurita, Nagano City, Nagano Prefecture
TEL
026-226-1311
Homepage URL
soundofdistiny@icloud.com
Sponsor or person
Institute
other
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
Kurita hospital
Address
695 Kurita, Nagano City, Nagano Prefecture
Tel
026-226-1311
soundofdistiny@icloud.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | 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
99
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
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 02 | 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 observation of schizophrenia patients infected with COVID19 who develop pneumonia.
Management information
Registered date
| 2023 | Year | 01 | Month | 31 | Day |
Last modified on
| 2023 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057165
