UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of a wearable biosensor for patients with COVID-19 or cardiopulmonary diseases
Acronym	Efficacy of a wearable biosensor for patients with COVID-19 or cardiopulmonary diseases
Scientific Title	Efficacy of a wearable biosensor for patients with COVID-19 or cardiopulmonary diseases
Scientific Title:Acronym	Efficacy of a wearable biosensor for patients with COVID-19 or cardiopulmonary diseases
Region	Japan

Condition
Condition	i) SARS-CoV-2 PCR positive COVID-19 patient ii) Heart failure iii) Sleep apnea syndrome iv) Asthma v) Chronic obstructive pulmonary disease vi) Intestinal pneumonia vii) Pulmonary mycobacterium avium complex disease viii) Pediatric inguinal hernia ix) Congenital cystic disease of lung x) Pediatric metastatic lung tumors xi) Pneumonia
Classification by specialty	Cardiology Pneumology Infectious disease Pediatrics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of a developed wearable biosensor compared with an existing reference medical device.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Pulse rate and SpO2
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	i) SARS-CoV-2 PCR positive COVID-19 patient ii) Heart failure iii) Sleep apnea syndrome iv) Asthma v) Chronic obstructive pulmonary disease vi) Intestinal pneumonia vii) Pulmonary mycobacterium avium complex disease viii) Pediatric inguinal hernia ix) Congenital cystic disease of lung x) Pediatric metastatic lung tumors xi) Pneumonia
Key exclusion criteria	1) Cannot use a developed medical device 2) Cannot obtain a written informed consent because of severe medical conditions (e.g. intubated) 3) Principle investigators considered inappropriate for eligibility 4) Pneumonia patients with A-DROP score equal or more than 3
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Akihiro Middle name Last name Nomura
Organization	Kanazawa University
Division name	Innovative Clinical Research Center / Department of Cardiovascular Medicine
Zip code	9208641
Address	13-1 Takaramachi, Kanazawa, Ishikawa
TEL	0762652049
Email	anomura@med.kanazawa-u.ac.jp

Public contact
Name of contact person	1st name Akihiro Middle name Last name Nomura
Organization	Kanazawa University
Division name	Innovative Clinical Research Center / Department of Cardiovascular Medicine
Zip code	9208641
Address	13-1 Takaramachi, Kanazawa, Ishikawa
TEL	0762652049
Homepage URL
Email	anomura@med.kanazawa-u.ac.jp

Sponsor
Institute	Innovative Clinical Research Center, Kanazawa University, Kanazawa, Japan
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Institute of Advanced Industrial Science and Technology (AIST), Keio University, Tohoku University, Nagoya University, CureApp Inc, Cosmic M.E. Inc
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical Ethics Committee of Kanazawa University
Address	13-1 Takaramachi, Kanazawa, Ishikawa
Tel	0762652110
Email	rinri@adm.kanazawa-u.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	金沢大学附属病院(石川県)、慶應大学病院(東京都)、東北大学病院(宮城県)、名古屋大学医学部附属病院(愛知県)

Other administrative information
Date of disclosure of the study information	2021 Year 03 Month 08 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	Completed
Date of protocol fixation	2021 Year 02 Month 05 Day
Date of IRB	2021 Year 02 Month 05 Day
Anticipated trial start date	2021 Year 03 Month 08 Day
Last follow-up date	2021 Year 03 Month 30 Day
Date of closure to data entry	2021 Year 03 Month 30 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 06 Month 30 Day

Other
Other related information	This study will start on March 8, 2021.

Management information
Registered date	2021 Year 03 Month 08 Day
Last modified on	2021 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049731