UMIN-CTR Clinical Trial

Basic information
Public title	The research on infections due to COVID-19
Acronym	The research on COVID-19
Scientific Title	The analysis of clinical data of infections due to COVID-19
Scientific Title:Acronym	The analysis of COVID-19
Region	Japan

Condition
Condition	COVID-19 infection
Classification by specialty	Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We analyze the clinical data from the patients with COVID-19 to contribute for the progress in medical care for OVID-19.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We analyze the data which are possible to the clinical course and the prognosis for patients with COVID-19.
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	The inpatients with COVID-19 in Kawasaki Medical School from 1st January 2020 to 31th December 2024
Key exclusion criteria	Of all objective patients, the people who reject to enroll this research.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Tomohiro Middle name Last name Oishi
Organization	Kawasaki Medical School
Division name	Pediatrics
Zip code	7010192
Address	577 Matsushima Kurashik-shi Okayama
TEL	086-462-1111
Email	oo0612@med.kawasaki-m.ac.jp

Public contact
Name of contact person	1st name Tomohiro Middle name Last name Oishi
Organization	Kawasaki Medical School
Division name	Pediatrics
Zip code	7010192
Address	577 Matsushima Kurashik-shi Okayama
TEL	086-462-1111
Homepage URL
Email	oo0612@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	Kawasaki Medical School
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	Kawasaki Medical School
Address	577 Matsushima Kurashik-shi Okayama
Tel	086-462-1111
Email	oo0612@med.kawasaki-m.ac.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	2021 Year 03 Month 05 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	Preinitiation
Date of protocol fixation	2021 Year 03 Month 05 Day
Date of IRB
Anticipated trial start date	2021 Year 04 Month 01 Day
Last follow-up date	2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	No particular

Management information
Registered date	2021 Year 03 Month 05 Day
Last modified on	2021 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049709