UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044225
Receipt number R000050509
Scientific Title Evaluation of rapid diagnostic test for SARS-CoV-2 infection
Date of disclosure of the study information 2021/06/30
Last modified on 2022/11/16 10:17:45

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Basic information

Public title

Evaluation of assay kit for detecting SARS-CoV-2 infection

Acronym

Evaluation of assay kit for detecting SARS-CoV-2 infection

Scientific Title

Evaluation of rapid diagnostic test for SARS-CoV-2 infection

Scientific Title:Acronym

Evaluation of rapid diagnostic test for SARS-CoV-2 infection

Region

Japan


Condition

Condition

Coronavirus disease 2019

Classification by specialty

Infectious disease Pediatrics Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of rapid diagnostic test for SARS-CoV-2 infection

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sensitivity, specificity and detection limit of rapid diagnostic test for SARS-CoV-2 infection

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Maneuver Other

Interventions/Control_1

Sample collection, assay with test kit

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

Patients that visit the medical institution during this study, and include the following conditions:
1) Patients with suspected SARS-CoV-2 infection based on symptoms.
2) Patients who agree to participate in this study.

Key exclusion criteria

1) Patients who are difficult to obtain clinical samples from.
2) For any reason other than above, patients who were determined by doctor as being unfit to participate in this study.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Daisuke
Middle name
Last name Tamura

Organization

Jichi Medical University Hospital

Division name

Paediatrics

Zip code

239-0498

Address

3311-1 Yakushiji, Shimono-shi, Tochigi, 329-0498, Japan

TEL

0285-44-2111

Email

dtamura@jichi.ac.jp


Public contact

Name of contact person

1st name Yuta
Middle name
Last name Maehara

Organization

Sekisui Medical Co., Ltd.

Division name

Research & Development

Zip code

103-0027

Address

1-3 Nihonbashi 2-chome, Chuo-ku Tokyo 103-0027, Japan

TEL

03-3272-0677

Homepage URL


Email

yuta.maehara@sekisui.com


Sponsor or person

Institute

Sekisui Medical Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Sekisui Medical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

NA

Name of secondary funder(s)



IRB Contact (For public release)

Organization

-

Address

-

Tel

-

Email

-


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

自治医科大学(栃木県)


Other administrative information

Date of disclosure of the study information

2021 Year 06 Month 30 Day


Related information

URL releasing protocol

https://www.ijidonline.com/article/S1201-9712(22)00517-3/fulltext

Publication of results

Published


Result

URL related to results and publications

https://www.ijidonline.com/article/S1201-9712(22)00517-3/fulltext

Number of participants that the trial has enrolled

16

Results

See https://www.ijidonline.com/article/S1201-9712(22)00517-3/fulltext

Results date posted

2022 Year 11 Month 16 Day

Results Delayed


Results Delay Reason

not applicable

Date of the first journal publication of results

2022 Year 11 Month 01 Day

Baseline Characteristics

See https://www.ijidonline.com/article/S1201-9712(22)00517-3/fulltext

Participant flow

See https://www.ijidonline.com/article/S1201-9712(22)00517-3/fulltext

Adverse events

not applicable

Outcome measures

See https://www.ijidonline.com/article/S1201-9712(22)00517-3/fulltext

Plan to share IPD

not applicable

IPD sharing Plan description

not applicable


Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 12 Month 15 Day

Date of IRB

2021 Year 01 Month 31 Day

Anticipated trial start date

2021 Year 01 Month 31 Day

Last follow-up date

2022 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 05 Month 17 Day

Last modified on

2022 Year 11 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050509


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name