UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040931 |
|---|---|
| Receipt number | R000046736 |
| Scientific Title | The association between the neutralizing activity and the amount of antibody in early stages of SARS-CoV-2 infection: A multicenter observational study |
| Date of disclosure of the study information | 2020/06/28 |
| Last modified on | 2022/05/19 17:49:54 |
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Basic information
Public title
The association between the neutralizing activity and the amount of antibody in early stages of SARS-CoV-2 infection: A multicenter observational study
Acronym
The association between the neutralizing activity and the amount of antibody in early stages of SARS-CoV-2 infection: A multicenter observational study
Scientific Title
The association between the neutralizing activity and the amount of antibody in early stages of SARS-CoV-2 infection: A multicenter observational study
Scientific Title:Acronym
The association between the neutralizing activity and the amount of antibody in early stages 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
This study's primary purpose is to evaluate the correlation between the neutralizing activity and the NP antibody titers in the acute phase of SARS-CoV-2 infection (within 30 days from the onset).
Basic objectives2
Others
Basic objectives -Others
The secondary objectives are
(1) to examine the correlation between neutralizing activity and the SP antibody titer;
(2) to separately assess the correlation between the NP or the SP antibody titers and the neutralizing activity by the time from the onset of symptoms;
(3) to evaluate the positive rate of the NP or the SP antibodies separately by time from the onset of symptoms;
(4) and to assess the diagnostic sensitivity of these antibody tests depending on the time from onset.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The correlation between neutralizing activity and NP antibody titer during the acute phase of SARS-CoV-2 infection
Key secondary outcomes
(1) The correlation between neutralizing activity and SP antibody titer in the acute phase of SARS-CoV-2 infection
(2) The correlation between the NP or the SP antibody titers and the neutralizing activity by the time from the onset of symptoms (10 days or less, 11 to 20 days, 21 to 30 days)
(3) The positive rate of the NP antibody test
(4) The effect of administered drugs on the neutralizing activity
(5) The relationship between neutralizing activity and the clinical 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
<A prospective observational study>
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) Positive results of gene amplification test (PCR or Lamp test) or antigen test for SARS-CoV-2 in pharyngeal swabs, nasopharyngeal swabs, or saliva.
(3) A person with any symptoms caused by SARS-CoV-2 infection
(4) Those who need to be hospitalized for SARS-CoV-2 infection
(5) Patients who have given their written informed consent to participate in this study.
<A retrospective observational study>
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) Positive results of gene amplification test (PCR or Lamp test) or antigen test for SARS-CoV-2 in pharyngeal swabs, nasopharyngeal swabs, or saliva.
(3) A person with any symptoms caused by COVID-19
(4) Those who had needed to be hospitalized for COVID-19
(5) The patient who has had at least one blood draw within 30 days of the onset from the disease and the residual serum must have been stored at least 200 micro litter
(6) Patients who meet any of the following
1. Patients who are outpatients or continuously hospitalized at the time of registration and who have given their written informed consent for this study
2. Patients who have already completed their hospital visits and have not applied for opt-out denial of the information use
Key exclusion criteria
<A prospective observational study>
Patients who meet the following criteria are excluded
(1) Patients with mental illness or other conditions that are believed to affect their ability to consent.
(2) Other patients who are deemed by the researcher to be unsuitable to participate in the research.
<A retrospective observational study>
There are no exclusion criteria.
Target sample size
150
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 | 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
Homepage URL
meta.analysis.r@gmail.com
Sponsor or person
Institute
Yokohama City University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University School of Medicine
Address
3-9, Fukuura, Kanazawa-ku, Yokohama City
Tel
045-787-2800
meta.analysis.r@gmail.com
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 | 28 | 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 | 12 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study is a multicenter, retrospective, and prospective observational study.
Management information
Registered date
| 2020 | Year | 06 | Month | 28 | 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=R000046736
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
