UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044177
Receipt number R000050450
Scientific Title A study of nasal sampling for SARS-COV-2 and influenza antigen testing
Date of disclosure of the study information 2021/05/11
Last modified on 2022/11/11 09:54:14

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Basic information

Public title

A study of nasal sampling for SARS-COV-2 and influenza antigen testing

Acronym

A study of nasal sampling for SARS-COV-2 and influenza antigen testing

Scientific Title

A study of nasal sampling for SARS-COV-2 and influenza antigen testing

Scientific Title:Acronym

A study of nasal sampling for SARS-COV-2 and influenza antigen testing

Region

Japan


Condition

Condition

Patients with suspected COVID-19 or influenza

Classification by specialty

Medicine in general Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

SARS-CoV-2 antigen and influenza antigen testing of the nasal cavity will be examined for concordance with antigen testing in nasopharyngeal examination.

Basic objectives2

Others

Basic objectives -Others

Usefulness of specimen collection methods

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluate the concordance between nasal Flu and nasopharyngeal antigen testing for SARS-CoV-2.

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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Antigen and nucleic acid detection test for SARS-CoV-2 and influenza in nasal vestibule and nasopharyngeal swabs

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Patients who have received sufficient explanation of the purpose, methods, and significance of this study, and who can freely and voluntarily obtain written consent from themselves or their legal representative (legal guardian, legal representative).
(2) Patients who are 20 years of age or older at the time of consent.
(3) Patients suspected of being infected with a new coronavirus or influenza within 9 days of onset.

Key exclusion criteria

(1) Patients who have anatomical problems that make it difficult to collect nasopharyngeal swabs
(2) Patients who are otherwise judged by the investigator to be ineligible for this study.

Target sample size

160


Research contact person

Name of lead principal investigator

1st name Kei
Middle name
Last name Yamamoto

Organization

National Center for Global Health and Medicine

Division name

Disease Control and Prevention Center

Zip code

1628655

Address

1-21-1 Toyama, Shinjuku-ku, Tokyo

TEL

03-3202-7181

Email

kyamamoto@hosp.ncgm.go.jp


Public contact

Name of contact person

1st name Kei
Middle name
Last name Yamamoto

Organization

National Center for Global Health and Medicine

Division name

Disease Control and Prevention Center

Zip code

1628655

Address

1-21-1 Toyama, Shinjuku-ku, Tokyo

TEL

03-3202-7181

Homepage URL


Email

kyamamoto@hosp.ncgm.go.jp


Sponsor or person

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name



Funding Source

Organization

Fujirebio, 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

National Center for Global Health and Medicine

Address

1-21-1 Toyama, Shinjuku-ku, Tokyo

Tel

03-3202-7181

Email

kenkyu-shinsa@hosp.ncgm.go.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 05 Month 11 Day


Related information

URL releasing protocol

https://doi.org/10.1016/j.jiac.2022.09.001

Publication of results

Unpublished


Result

URL related to results and publications

https://doi.org/10.1016/j.jiac.2022.09.001

Number of participants that the trial has enrolled

128

Results

https://doi.org/10.1016/j.jiac.2022.09.001

Results date posted

2022 Year 05 Month 12 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Symptomatic patient with suspected COVID-19

Participant flow

https://doi.org/10.1016/j.jiac.2022.09.001

Adverse events

None

Outcome measures

https://doi.org/10.1016/j.jiac.2022.09.001

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 11 Month 22 Day

Date of IRB

2020 Year 12 Month 11 Day

Anticipated trial start date

2021 Year 01 Month 21 Day

Last follow-up date

2021 Year 08 Month 24 Day

Date of closure to data entry

2021 Year 08 Month 26 Day

Date trial data considered complete

2021 Year 10 Month 20 Day

Date analysis concluded

2022 Year 09 Month 08 Day


Other

Other related information



Management information

Registered date

2021 Year 05 Month 11 Day

Last modified on

2022 Year 11 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050450


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name