UMIN-CTR Clinical Trial

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

Japanese Patients diagnosed as COVID-19

Classification by specialty

Medicine in general	Pneumology	Infectious disease

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

The Japanese Association for Infectious Diseases

Institute

Department

Personal name

Organization

Astellas Pharma Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.)

Registered date

2021

Year

03

Month

31

Day

Last modified on

2022

Year

10

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049989