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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041021
Receipt No. 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 2021/09/09

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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
Institute Yokohama City University
Institute
Department

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 No longer recruiting
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
2021 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.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


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