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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041227
Receipt No. 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 2020/07/27

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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 previous COVID-19 infection confirmed by the PCR or Lamp testing of pharyngeal swab, nasopharyngeal swab, or saliva.
(4) Patients with any symptoms caused by COVID-19 infection.
(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 140

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
Email 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
Email agoto@yokohama-ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

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
Email 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 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 Preinitiation
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
2020 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047079

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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