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Prospective Assay for SARS-CoV-2 (COVID-19) Antibody Detection Indirectly by Immunofluorescence: SARS-CoV2 IIF Method (IIF)

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ClinicalTrials.gov Identifier: NCT04429620
Recruitment Status : Recruiting
First Posted : June 12, 2020
Last Update Posted : June 25, 2020
Sponsor:
Collaborator:
Bilogical Research Centre, Szeged
Information provided by (Responsible Party):
Szeged University

Tracking Information
First Submitted Date June 10, 2020
First Posted Date June 12, 2020
Last Update Posted Date June 25, 2020
Actual Study Start Date May 30, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 10, 2020)
Sensitivity of the method by SARS-CoV2 ELISA compared [ Time Frame: 8 months ]
Sensitivity of the method by SARS-CoV2 ELISA compared
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 10, 2020)
Detectability of the antibodies IgA type against SARS-CoV2 virus [ Time Frame: 8 months ]
Detectability of the antibodies IgA type against SARS-CoV2 virus in the early stages of the disease.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Assay for SARS-CoV-2 (COVID-19) Antibody Detection Indirectly by Immunofluorescence: SARS-CoV2 IIF Method
Official Title Prospective Assay for SARS-CoV-2 Antibody Detection Indirectly by Immunofluorescence: SARS-CoV2 IIF Method
Brief Summary Prospective assay for SARS-CoV-2 antibody detection indirectly by immunofluorescence: SARS-CoV2 IIF method
Detailed Description

Sample preparation, serum separation by centrifugation

  • 100 µl of serum for standard SARS-CoV2 ELISA is used according to the instructions for use.
  • 100 µl of serum indirect immunofluorescent (IIF) method is used, the samples thus prepared analysis is performed under an automated microscope
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults, Hungarian
Condition Sars-CoV2
Intervention Diagnostic Test: Immunfluorescence
Serum indirect immunofluorescent (IIF) method is used, analysis is performed under an automated microscope.
Study Groups/Cohorts
  • Positive group
    Subjects are diagnosed with SARS-CoV2 by qPCR assay.
    Intervention: Diagnostic Test: Immunfluorescence
  • Negative group
    Subject were 2 times proved negative SARS-CoV2 by qPCR assay.
    Intervention: Diagnostic Test: Immunfluorescence
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 10, 2020)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Person over 18 years of age
  • Signing a package leaflet and a informal consent
  • In the case of a positive group, confirmed by SARS-CoV2 qPCR Patient with COVID-19 or recovered individual.
  • In case of negative group by SARS-CoV2 qPCR test 2 negative in COVID-19 suffering individual

Exclusion Criteria:

  • Refuses to sign the consent form
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Katalin Burián, MD +36 62 544 000 burian.katalin@med.u-szeged.hu
Contact: Dávid Pintér, Pharm. D.
Listed Location Countries Hungary
Removed Location Countries  
 
Administrative Information
NCT Number NCT04429620
Other Study ID Numbers SARS-CoV-2-IIF-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Szeged University
Study Sponsor Szeged University
Collaborators Bilogical Research Centre, Szeged
Investigators
Principal Investigator: Katalin Burián, MD University of Szeged, Institute of Clinical Microbilogy
PRS Account Szeged University
Verification Date June 2020