UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041227 |
|---|---|
| Receipt number | R000047079 |
| Scientific Title | Immune responses in the convalescence stage of COVID-19 patients |
| Date of disclosure of the study information | 2020/07/28 |
| Last modified on | 2022/12/08 21:54:39 |
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Basic information
Public title
Immune responses in the convalescence stage of COVID-19 patients
Acronym
Immune responses in the convalescence stage of COVID-19 patients
Scientific Title
Immune responses in the convalescence stage of COVID-19 patients
Scientific Title:Acronym
Immune responses in the convalescence stage of COVID-19 patients
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 objective 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 positive PCR or other test for COVID-19 infection.
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 presence of symptoms, hospitalization, 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 at 26 (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 between the neutralizing activity and the NP antibody titers at 26 (20 - 32) and 52 (46 - 58) weeks after the date of the first positive PCR or other test for COVID-19 infection
Key secondary outcomes
(1) 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 infection by sex and age group.
(2) Correlation between neutralizing activity and NP antibody titer by presence of symptoms
(3) Correlation between neutralizing activity and NP antibody titer by severity of illness (severe cases requiring tracheal intubation or ECMO)
(4) 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 infection, including PCR
(5) 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.
(6) 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 infection.
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) Patients who are 20 years of age or older at the time of registration.
(2) Patients residing in Japan.
(3) Patients with positive results on the PCR, Lamp, or antigen testing of pharyngeal swab, nasopharyngeal swab, or saliva.
(4) Patients with previous COVID-19 infection confirmed by physicians.
(5) Patients who have provided consent to inquire about information on diagnosis and treatment of COVID-19 from the medical institution or health center where the diagnosis or treatment of COVID-19 was performed.
(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 with a fever of 37 degrees or more, cough or breathlessness, sore throat, abnormalities in taste or smell, intensive contact with COVID-19 patients, or a history of foreign travel within 2 weeks of the scheduled blood collection date.
(3) Patients who are deemed by the researcher to be unsuitable to participate in the research.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Takeharu |
| Middle name | |
| Last name | Yamanaka |
Organization
Yokohama City University, School of Medicine
Division name
Department of Biostatistics
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama City
TEL
045-787-2572
yamanaka@yokohama-cu.ac.jp
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
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 | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/ofid/article/9/2/ofab626/6459162?login=false
Number of participants that the trial has enrolled
497
Results
Antibody titers of NP-IgG, RBD-IgG, and nAbs were higher in severe and moderate cases than in mild cases at 12 months after onset. Although the nAb levels were likely to confer adequate protection against wild-type viral infection, the neutralization activity to recently circulating variants in some of the mild cases (~30%) was undermined, implying the susceptibility to reinfection with the variants of concerns (VOCs).
Results date posted
| 2022 | Year | 12 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 12 | Month | 10 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study.
Management information
Registered date
| 2020 | Year | 07 | Month | 27 | Day |
Last modified on
| 2022 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047079
| 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 |
