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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050989


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name