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The association between the neutralizing activity and the amount of antibody in early stages of SARS-CoV-2 infection: A multicenter observational study

The association between the neutralizing activity and the amount of antibody in early stages of SARS-CoV-2 infection: A multicenter observational study - The association between the neutralizing activity and the amount of antibody in early stages of SARS-CoV-2 infection: A multicenter observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000040931
Enrollment
150
Registered
2020-06-28
Start date
2020-07-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 (SARS-CoV-2 infection)

Interventions

None listed

Sponsors

Yokohama City University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
The correlation between neutralizing activity and NP antibody titer during the acute phase of SARS-CoV-2 infection

Secondary

MeasureTime frame
(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

Countries

Japan

Contacts

Public ContactTakahiro Mihara

Yokohama City University School of Medicine Graduate School of Data Science

meta.analysis.r@gmail.com045-787-2800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026