UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| 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 | 2022/05/19 (Ver. 10) |
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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 | |
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| Condition | ||||
| Condition | COVID-19 (SARS-CoV-2 infection) | |||
| Classification by specialty |
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| 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 | |
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| Purpose of intervention | |
| Type of intervention | |
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| Interventions/Control_10 | |
| Eligibility | ||||
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| 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. |
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| 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. |
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| Target sample size | 140 | |||
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| Name of lead principal investigator |
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| 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 | |||||||
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| 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 | |
| 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 |
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| 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 | |
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| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | |
| Publication of results | Unpublished |
| Result | |
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| Baseline Characteristics | |
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| Plan to share IPD | |
| IPD sharing Plan description | |
| Progress | |||||||
| Recruitment status | Completed | ||||||
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| Other | |
| Other related information | This study is a multicenter, prospective observational study. |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046800 |
