UMIN-CTR Clinical Trial

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	2022 Year 03 Month 31 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	2022 Year 10 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049989