UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040816
Receipt number R000046573
Scientific Title Relationship between age and viral load in Coronavirus Disease 2019 (COVID-19) patients
Date of disclosure of the study information 2020/06/17
Last modified on 2024/02/03 05:41:24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Relationship between age and viral load in novel coronavirus patients

Acronym

Viral load of novel coronavirus patients

Scientific Title

Relationship between age and viral load in Coronavirus Disease 2019 (COVID-19) patients

Scientific Title:Acronym

Age and viral load in COVID-19 patients

Region

Japan


Condition

Condition

Coronavirus Disease 2019 (COVID-19)

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of viral load of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)between child and adult COVID-19 cases.

Basic objectives2

Others

Basic objectives -Others

We can consider the reason why symptom of COVID-19 cases are different between children and adults.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Relationship between age and virus load in COVID-19 cases

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

Hospitalized patients by COVID-19
1) Children under 20 years old. 3-10 cases
2) Adult between over 20 and under 60 years old. 3-10 cases
3) Adult over 60 years old. 3-10 cases

Key exclusion criteria

Out patients

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Tomohiro
Middle name
Last name Katsuta

Organization

St. Marianna university school of medicine

Division name

Department of pediatrics

Zip code

216-8511

Address

2-16-1 Sugao Miyamae-ku Kawasaki-shi Kanagawa, Japan

TEL

044-977-8111

Email

katsuta-7-@marianna-u.ac.jp


Public contact

Name of contact person

1st name Tomohiro
Middle name
Last name Katsuta

Organization

St. Marianna university school of medicine

Division name

Department of pediatrics

Zip code

216-8511

Address

2-16-1 Sugao Miyamae-ku Kawasaki-shi Kanagawa, Japan

TEL

044-977-8111

Homepage URL


Email

katsuta-7-@marianna-u.ac.jp


Sponsor or person

Institute

St. Marianna university school of medicine

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

St. Marianna university school of medicine

Address

2-16-1 Sugao Miyamae-ku Kawasaki-shi Kanagawa, Japan

Tel

044-977-8111

Email

katsuta-7-@marianna-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 06 Month 17 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

Terminated

Date of protocol fixation

2020 Year 06 Month 04 Day

Date of IRB

2020 Year 06 Month 11 Day

Anticipated trial start date

2020 Year 06 Month 18 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

Not applicable


Management information

Registered date

2020 Year 06 Month 17 Day

Last modified on

2024 Year 02 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046573


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name