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
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
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
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
