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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043802
Receipt No. R000049989
Scientific Title Exploratory Research on Potential Risk Factors Relevant to Severe Acute Respiratory Syndrome Coronavirus2 Infection (COVID-19) in Japanese Patients. - A Multicenter Retrospective Observational Study
Date of disclosure of the study information 2021/04/01
Last modified on 2021/04/01

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Basic information
Public title Exploratory Research on Potential Risk Factors Relevant to Severe Acute Respiratory Syndrome Coronavirus2 Infection (COVID-19) in Japanese Patients.
- A Multicenter Retrospective Observational Study
Acronym Exploratory Research on Potential Risk Factors Relevant to Severe Acute Respiratory Syndrome Coronavirus2 Infection (COVID-19)
Scientific Title Exploratory Research on Potential Risk Factors Relevant to Severe Acute Respiratory Syndrome Coronavirus2 Infection (COVID-19) in Japanese Patients.
- A Multicenter Retrospective Observational Study
Scientific Title:Acronym JAID's COVID-19 Registry Research (JAID-COVID)
Region
Japan

Condition
Condition Japanese Patients diagnosed as COVID-19
Classification by specialty
Medicine in general Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore potential risk factors which are associated with severe COVID-19 in Japanese patients.
Basic objectives2 Others
Basic objectives -Others Definitions of Severe COVID-19: Clinical condition which requires treatment with mechanical ventilator, extracorporeal membrane oxygenation (ECMO), newly introduced blood purification therapy [CHDF (continuous hemodiafiltration) for COVID-19 treatment], or death
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes To explore potential risk factors which are associated with severe COVID-19 in Japanese patients.
Definitions of Severe COVID-19: Clinical condition which requires treatment with mechanical ventilator, extracorporeal membrane oxygenation (ECMO), newly introduced blood purification therapy [CHDF (continuous hemodiafiltration) for COVID-19 treatment], or death
Key secondary outcomes (1) Association between severe COVID-19 and blood type.
(2) Association between Drugs for Treatment of Underlying Diseases and severe COVID-19
(3) Association between lymphocyte count / lymphocyte subsets and severe COVID-19
(4) Association between Vaccination History and severe COVID-19
(5) Association between Allergic Diseases and severe COVID-19
(6) Alternative definitions of severe COVID-19
(7) Predictive factors of complications associated with COVID-19, such as thrombosis (deep venous thrombosis, pulmonary embolism, cerebral infarction, myocardial infarction, and other thromboembolism)
(8) Association between prognosis of COVID-19 and anticoagulant use
(9) Frequency and Clinical Characteristics of Infectious (Bacterial, Fungal, and Viral) Complications during COVID-19 treatment.
(10) Clinical characteristics (disease duration, duration suffering from fever, etc.) of the elderly patients with COVID-19
(11) Causative microorganisms and Clinical Characteristics of Infectious Complications associated with COVID-19
(12) Types, incidence and prognosis of sequelae associated with COVID-19
(13) Clinical Characteristics of patients with COVID-19 who require Obstetric Treatment
(14) Clinical Characteristics of patients with COVID-19 who require Surgical Treatment
(15) Initial symptoms of COVID-19

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)Japanese patients who were diagnosed with COVID-19 after January 1, 2020 by any of the following methods, reported to Local Government in accordance with Infectious Disease Law in Japan, and underwent inpatient COVID-19 treatment at a medical institution:
*Detection of pathogens by isolation and identification
*Detection of pathogen genes by nucleic acid amplification [polymerase chain reaction (PCR), Loop-Mediated Isothermal Amplification (LAMP), etc.] from specimens
*Detection of antigens of pathogens by antigen qualitative test
*Detection of antigens of pathogens by antigen quantitative test
(2)Japanese patients who were discharged (including death) or transferred to another hospital after completion of inpatient treatment for COVID-19 at a medical institution by March 31, 2021.
Key exclusion criteria (1)Patients refusing to provide medical information for this research.
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Kazuhiro
Middle name
Last name Tateda
Organization Toho University
Division name Department of Microbiology and Infectious Diseases
Zip code 143-8540
Address 5-21-16 Omori, Ota-ku, Tokyo 143-8540, Japan
TEL 03-3762-4151
Email kazu@med.toho-u.ac.jp

Public contact
Name of contact person
1st name Kazuyoshi
Middle name
Last name Kawakami
Organization Tohoku University
Division name Medical Microbiology, Mycology and Immunology, Graduate School of Medicine
Zip code 980-8575
Address 2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Japan
TEL 022-717-7946
Homepage URL
Email kawakami@med.tohoku.ac.jp

Sponsor
Institute The Japanese Association for Infectious Diseases
Institute
Department

Funding Source
Organization Astellas Pharma Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research Ethics Committee, School of Medicine, Tohoku University
Address Seiryo-machi, 2-1, Sendai
Tel 022-717-8007
Email med-kenkyo@grp.tohoku.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 04 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 Enrolling by invitation
Date of protocol fixation
2021 Year 03 Month 30 Day
Date of IRB
2021 Year 03 Month 22 Day
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The total number of COVID-19 patients as well as the number and percent registered for this research will be calculated by medical institution.
Summary statistics will be calculated for patient characteristics, laboratory tests, and clinical information related to COVID-19. These items and outcomes may also be summarized by one or more of the following:
Presence or absence of severe COVID-19
Blood type
Presence or absence of drugs for the treatment of underlying diseases
Lymphocyte count and lymphocyte subsets
Presence or absence of prior vaccination
Presence or absence of allergic disease
Presence or absence of complications of thrombosis (deep venous thrombosis, pulmonary embolism, cerebral infarction, myocardial infarction, and other thromboembolism) etc.
With or without treatment of anticoagulant
Presence or absence of infectious (bacterial, fungal, viral) complications
Elderly or non-elderly (65+ or <65)
Presence or absence of infectious complications, and by major infectious complication
With or without obstetric treatment
With or without surgical treatment
Time of admission (1st wave, 2nd wave, etc.)

Management information
Registered date
2021 Year 03 Month 31 Day
Last modified on
2021 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049989

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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