UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041021
Receipt number R000046800
Scientific Title The association between the neutralizing activity and the amount of antibody in the convalescence stage of SARS-CoV-2 infection: A multicenter observational study
Date of disclosure of the study information 2020/07/07
Last modified on 2022/05/19 17:55:49

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Basic information

Public title

The association between the neutralizing activity and the amount of antibody in the convalescence stage of SARS-CoV-2 infection: A multicenter observational study

Acronym

The association between the neutralizing activity and the amount of antibody in the convalescence stage of SARS-CoV-2 infection: A multicenter observational study

Scientific Title

The association between the neutralizing activity and the amount of antibody in the convalescence stage of SARS-CoV-2 infection: A multicenter observational study

Scientific Title:Acronym

The association between the neutralizing activity and the amount of antibody in the convalescence stage of SARS-CoV-2 infection: A multicenter observational study

Region

Japan


Condition

Condition

COVID-19 (SARS-CoV-2 infection)

Classification by specialty

Medicine in general Pneumology Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The primary purposes of the study is to evaluate the correlation between the neutralizing activity and the NP antibody titers at 26 (20 - 32) and 52 (46 - 58) weeks after the date of the first PCR or other positive results

Basic objectives2

Others

Basic objectives -Others

The secondary purposes of the study are to evaluate the correlation between neutralizing activity and NP antibody titers by severity of illness (cases requiring tracheal intubation or ECMO), the distribution of neutralizing activity, NP and SP antibodies, and the correlation between neutralizing activity and SP antibody titers at26 (20 - 32) and 52 (46 - 58) weeks after the date of the first PCR or other positive results.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Correlation of neutralizing activity and NP antibody titers against SARS-CoV-2 at 26 (20 - 32) and 52 (46 - 58) weeks after the date of the first positive PCR or other test for COVID-19

Key secondary outcomes

(1) Correlation between neutralizing activity and NP antibody titer by severity of illness (severe cases requiring tracheal intubation or ECMO)
(2) Distribution of NP antibodies (quantitative and qualitative), SP antibodies (quantitative), and neutralizing activity at 26 (20 - 32) and 52 (46 - 58) weeks after the first positive PCR or other test for COVID-19 by sex and age group
(3) Correlation between neutralizing activity and SP antibody titers at 26 (20 - 32) and 52 (46 - 58) weeks after the first positive test for COVID-19, including PCR
(4) Association of baseline background factors, hospitalization status, treatment status, and severity of disease with neutralizing activity values at 26 (20 - 32) and 52 (46 - 58) weeks after the first positive PCR or other test.
(5) Association of baseline background factors, treatment status, and severity of disease with NP antibody titers at 26 (20 - 32) and 52 (46 - 58) weeks after the first positive PCR or other test for COVID-19.


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

Patients who meet all of the following criteria are eligible.
(1) Those who are 20 years of age or older at the time of registration.
(2) Persons residing in Japan.
(3) Those who have tested positive as a result of gene amplification testing of pharyngeal swab, nasopharyngeal swab, or saliva by PCR test or Lamp method.
(4) A person with any symptoms caused by COVID-19 infection.
(5) A person who required hospitalization for COVID-19.
(6) Patients who have given their written informed consent to participate in this study.

Key exclusion criteria

Patients who meet the following criteria are excluded.
(1) Patients with mental illness or other conditions that might affect their ability to consent
(2) Patients who are deemed by the researcher to be unsuitable to participate in the research.

Target sample size

140


Research contact person

Name of lead principal investigator

1st name Takahiro
Middle name
Last name Mihara

Organization

Yokohama City University, School of Medicine

Division name

Graduate School of Data Science

Zip code

236-0004

Address

3-9, Fukuura, Kanazawa-ku, Yokohama City

TEL

045-787-2800

Email

meta.analysis.r@gmail.com


Public contact

Name of contact person

1st name Atsushi
Middle name
Last name Goto

Organization

Yokohama City University, Graduate School of Data Science

Division name

Department of Health Data Science

Zip code

236-0027

Address

22-2 Seto, Kanazawa-ku

TEL

045-787-2215

Homepage URL


Email

agoto@yokohama-ac.jp


Sponsor or person

Institute

Yokohama City University

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Yokohama City University Hospital

Address

3-9, Fukuura, Kanazawa-ku, Yokohama City

Tel

045-370-7627

Email

rinri@yokohama-cu.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 07 Month 07 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

2020 Year 06 Month 24 Day

Date of IRB

2020 Year 07 Month 08 Day

Anticipated trial start date

2020 Year 07 Month 13 Day

Last follow-up date

2021 Year 07 Month 31 Day

Date of closure to data entry

2021 Year 07 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is a multicenter, prospective observational study.


Management information

Registered date

2020 Year 07 Month 07 Day

Last modified on

2022 Year 05 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046800


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name