NCT04429620

Brief Summary

Prospective assay for SARS-CoV-2 antibody detection indirectly by immunofluorescence: SARS-CoV2 IIF method

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 25, 2020

Status Verified

June 1, 2020

Enrollment Period

7 months

First QC Date

June 10, 2020

Last Update Submit

June 23, 2020

Conditions

Sars-CoV2

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of the method by SARS-CoV2 ELISA compared

    Sensitivity of the method by SARS-CoV2 ELISA compared

    8 months

Secondary Outcomes (1)

  • Detectability of the antibodies IgA type against SARS-CoV2 virus

    8 months

Study Arms (2)

Positive group

Subjects are diagnosed with SARS-CoV2 by qPCR assay.

Diagnostic Test: Immunfluorescence

Negative group

Subject were 2 times proved negative SARS-CoV2 by qPCR assay.

Diagnostic Test: Immunfluorescence

Interventions

ImmunfluorescenceDIAGNOSTIC_TEST

Serum indirect immunofluorescent (IIF) method is used, analysis is performed under an automated microscope.

Negative groupPositive group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults, Hungarian

You may qualify if:

  • 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

You may not qualify if:

  • Refuses to sign the consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Szeged, Albert Szent-Györgyi Health Center

Szeged, Hungary

RECRUITING

Related Links

Study Officials

  • Katalin Burián, MD

    University of Szeged, Institute of Clinical Microbilogy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katalin Burián, MD

CONTACT

+36 62 544 000burian.katalin@med.u-szeged.hu

Dávid Pintér, Pharm. D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 12, 2020

Study Start

May 30, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

June 25, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)