UMIN-CTR Clinical Trial

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
Email	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
Email	akutagawa.masaaki763@eps.co.jp

Sponsor
Institute	Medical Corporation Tsurukamekai Shinjuku Tsurukame Clinic
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050989