UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040278
Receipt number R000045953
Scientific Title Had COVID-19 Spread in Nagasaki Prefecture before the first confirmed case?
Date of disclosure of the study information 2020/05/08
Last modified on 2021/05/01 11:11:36

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Basic information

Public title

Had COVID-19 Spread in Nagasaki Prefecture before the first confirmed case?

Acronym

Had COVID-19 Spread in Nagasaki Prefecture before the first confirmed case?

Scientific Title

Had COVID-19 Spread in Nagasaki Prefecture before the first confirmed case?

Scientific Title:Acronym

Had COVID-19 Spread in Nagasaki Prefecture before the first confirmed case?

Region

Japan


Condition

Condition

COVID-19

Classification by specialty

Pneumology Infectious disease Laboratory medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm whether the patients with COVID-19 existed or not before the first patients with COVID-19 was confirmed in Nagasaki Prefecture.

Basic objectives2

Others

Basic objectives -Others

To confirm whether the patients with COVID-19 existed or not before the first patients with COVID-19 was confirmed in Nagasaki Prefecture.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Detection rate of SARS-CoV-2 in the residual nasopharyngeal swabs obtained between November 2019 and March 13 2020.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Nasopharyngeal swabs obtained for diagnosis of Influenzavirus infections between November 2019 and March 13 2020.

Key exclusion criteria

1. Sample was not stored below -20 Celsius
2. Sample volume was 20 microliter or less

Target sample size

182


Research contact person

Name of lead principal investigator

1st name Katsunori
Middle name
Last name Yanagihara

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Department of Laboratory Medicine

Zip code

852-8501

Address

Sakamoto 1-7-1, Nagasaki City

TEL

095-819-7574

Email

k-yanagi@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name Norihito
Middle name
Last name Kaku

Organization

Nagasaki University Hospital

Division name

Department of Laboratory Medicine

Zip code

852-8501

Address

Sakamoto 1-7-1, Nagasaki City

TEL

095-819-7574

Homepage URL


Email

kaku-ngs@umin.ac.jp


Sponsor or person

Institute

Nagasaki University

Institute

Department

Personal name



Funding Source

Organization

Nagasaki University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagasaki University Hospital

Address

Sakamoto 1-7-1, Nagasaki City

Tel

095-819-7229

Email

gaibushikin@ml.nagasaki-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



Other administrative information

Date of disclosure of the study information

2020 Year 05 Month 08 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.sciencedirect.com/science/article/pii/S1286457921000344?via%3Dihub

Number of participants that the trial has enrolled

182

Results

This retrospective study evaluated stored nasopharyngeal swab samples from Japanese patients with influenza-like illness during the 2019/2020 season. We aimed to determine whether COVID-19 had spread in the community before the first confirmed case. When the first COVID-19 case was reported in Nagasaki prefecture, the number of influenza cases were very low. No positive results for SARS-CoV-2 were detected in 182 samples that were obtained from adult outpatients.

Results date posted

2021 Year 05 Month 01 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 03 Month 26 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 04 Month 30 Day

Date of IRB

2020 Year 05 Month 11 Day

Anticipated trial start date

2020 Year 06 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

N/A


Management information

Registered date

2020 Year 04 Month 30 Day

Last modified on

2021 Year 05 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045953


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name