UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044638 |
|---|---|
| Receipt number | R000050989 |
| Scientific Title | Observational study on the acquisition of immunity in convalescent people with SARS-CoV-2(COVID-19) infection |
| Date of disclosure of the study information | 2021/06/24 |
| Last modified on | 2021/11/04 14:22:21 |
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Basic information
Public title
Observational study on the acquisition of immunity in convalescent people with Novel Coronavirus(COVID-19) infection
Acronym
SARS-CoV-2 observational study
Scientific Title
Observational study on the acquisition of immunity in convalescent people with SARS-CoV-2(COVID-19) infection
Scientific Title:Acronym
SARS-CoV-2 observational study
Region
| Japan |
Condition
Condition
SARS-CoV-2 infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the humoral immune response of convalescent patients with SARS-CoV-2 infection to collect basic information for the development of new prophylactic vaccines and new therapeutic agents against COVID-19,
Basic objectives2
Others
Basic objectives -Others
The humoral immune response of convalescent patients with SARS-CoV-2 infection
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Neutralizing activity of SARS-CoV-2 against Pseudovirus in convalescent patients with SARS-CoV-2 infection
(2)SARS-CoV-2 spike (S) glycoprotein specific antibody titer in convalescent patients with SARS-CoV-2 infection
Key secondary 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
Specimens from non-hospitalized convalescent patients with SARS-CoV-2 infection and specimens from hospitalized convalescent patients with SARS-CoV-2 infection
(1)Specimens for which the research subject's free written consent to participate in this research has been obtained.
(2)Specimens from research subjects who have consented to the collection of information on such diagnosis and treatment to medical institutions and health centers that have diagnosed and treated SARS-CoV-2 infection.
(3)Specimens from research subjects who are 20 years old or older at the time of consent.
(4)Specimens from research subjects who have recovered from infection after testing positive for SARS-CoV-2 in a nucleic acid detection test or antigen test and have tested negative in a nucleic acid detection test or antigen test, or stored specimens from persons who have recovered from infection similar to the former.
(5)Specimens received after 20 days but before 180 days from the date of the test that tested positive for SARS-CoV-2
(6)For stored specimens,specimens with a residual of 300uL(serum)or more.
Key exclusion criteria
(1)Specimens from unrecovered SARS-CoV-2 infected individuals.
(2)Specimens from COVID-19 prophylactic vaccine recipients.
(3)Specimens from research subjects who have requested to withdraw consent.
(4) Specimens that the principal investigator or sub-investigator determines to be ineligible.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koshiro |
| Middle name | |
| Last name | Monzen |
Organization
Medical Corporation Tsurukamekai Shinjuku Tsurukame Clinic
Division name
General Outpatient
Zip code
151-0053
Address
3F Shinjuku Tokio Marine Nichido Building, 2-11-15 Yoyogi, Shibuya-ku, Tokyo
TEL
03-3299-0077
monzen@tsurukamekai.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Akutagawa |
Organization
EPS Corporation
Division name
Clinical Development Business Division Monitoring Center
Zip code
162-0814
Address
6F Iidabashi MF Building, 1-1 Shin Ogawa-cho, Shinjuku-ku, Tokyo
TEL
070-6697-4084
Homepage URL
akutagawa.masaaki763@eps.co.jp
Sponsor or person
Institute
Medical Corporation Tsurukamekai Shinjuku Tsurukame Clinic
Institute
Department
Personal name
Funding Source
Organization
AnGes , Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Joint Ethics Review Board
Address
Sanyokochi Bld. 3F, 1-14 Minamikubo, Kochi-shi, Kochi
Tel
042-648-5551
godou-irb@epsogo.co.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
| 2021 | Year | 06 | Month | 24 | 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
| 2021 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 21 | 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
Observational study
Management information
Registered date
| 2021 | Year | 06 | Month | 24 | Day |
Last modified on
| 2021 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050989
