UMIN-CTR Clinical Trial

Basic information
Public title	The association between the neutralizing activity and the amount of antibody in early stages of SARS-CoV-2 infection: A multicenter observational study
Acronym	The association between the neutralizing activity and the amount of antibody in early stages of SARS-CoV-2 infection: A multicenter observational study
Scientific Title	The association between the neutralizing activity and the amount of antibody in early stages of SARS-CoV-2 infection: A multicenter observational study
Scientific Title:Acronym	The association between the neutralizing activity and the amount of antibody in early stages of SARS-CoV-2 infection: A multicenter observational study
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	This study's primary purpose is to evaluate the correlation between the neutralizing activity and the NP antibody titers in the acute phase of SARS-CoV-2 infection (within 30 days from the onset).
Basic objectives2	Others
Basic objectives -Others	The secondary objectives are (1) to examine the correlation between neutralizing activity and the SP antibody titer; (2) to separately assess the correlation between the NP or the SP antibody titers and the neutralizing activity by the time from the onset of symptoms; (3) to evaluate the positive rate of the NP or the SP antibodies separately by time from the onset of symptoms; (4) and to assess the diagnostic sensitivity of these antibody tests depending on the time from onset.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The correlation between neutralizing activity and NP antibody titer during the acute phase of SARS-CoV-2 infection
Key secondary outcomes	(1) The correlation between neutralizing activity and SP antibody titer in the acute phase of SARS-CoV-2 infection (2) The correlation between the NP or the SP antibody titers and the neutralizing activity by the time from the onset of symptoms (10 days or less, 11 to 20 days, 21 to 30 days) (3) The positive rate of the NP antibody test (4) The effect of administered drugs on the neutralizing activity (5) The relationship between neutralizing activity and the clinical 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	<A prospective observational study> 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) Positive results of gene amplification test (PCR or Lamp test) or antigen test for SARS-CoV-2 in pharyngeal swabs, nasopharyngeal swabs, or saliva. (3) A person with any symptoms caused by SARS-CoV-2 infection (4) Those who need to be hospitalized for SARS-CoV-2 infection (5) Patients who have given their written informed consent to participate in this study. <A retrospective observational study> 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) Positive results of gene amplification test (PCR or Lamp test) or antigen test for SARS-CoV-2 in pharyngeal swabs, nasopharyngeal swabs, or saliva. (3) A person with any symptoms caused by COVID-19 (4) Those who had needed to be hospitalized for COVID-19 (5) The patient who has had at least one blood draw within 30 days of the onset from the disease and the residual serum must have been stored at least 200 micro litter (6) Patients who meet any of the following 1. Patients who are outpatients or continuously hospitalized at the time of registration and who have given their written informed consent for this study 2. Patients who have already completed their hospital visits and have not applied for opt-out denial of the information use
Key exclusion criteria	<A prospective observational study> Patients who meet the following criteria are excluded (1) Patients with mental illness or other conditions that are believed to affect their ability to consent. (2) Other patients who are deemed by the researcher to be unsuitable to participate in the research. <A retrospective observational study> There are no exclusion criteria.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Mihara
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
Email	meta.analysis.r@gmail.com

Public contact
Name of contact person	1st name Takahiro Middle name Last name Mihara
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
Homepage URL
Email	meta.analysis.r@gmail.com

Sponsor
Institute	Yokohama City University School of Medicine
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University School of Medicine
Address	3-9, Fukuura, Kanazawa-ku, Yokohama City
Tel	045-787-2800
Email	meta.analysis.r@gmail.com

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 06 Month 28 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	2020 Year 06 Month 12 Day
Date of IRB	2020 Year 07 Month 03 Day
Anticipated trial start date	2020 Year 07 Month 10 Day
Last follow-up date	2021 Year 01 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information	This study is a multicenter, retrospective, and prospective observational study.

Management information
Registered date	2020 Year 06 Month 28 Day
Last modified on	2022 Year 05 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046736