NCT04446338

Brief Summary

A sequential combination of different antibodies test against SARS-CoV-2 is evaluated. The protocol included a rapid test and several ELISA tests within a defined cohort of healthcare workers.

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
300

participants targeted

Target at 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 13, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

June 24, 2020

Status Verified

May 1, 2020

Enrollment Period

2 months

First QC Date

June 22, 2020

Last Update Submit

June 23, 2020

Conditions

Keywords

SeroprevalenceCovid-19

Outcome Measures

Primary Outcomes (1)

  • Seroprevalence

    Rate of anti-SARS-CoV-2 Antibodies

    through study completion, maximum of one year

Secondary Outcomes (2)

  • Agreement of the test results and questionnaire

    through study completion, maximum of one year

  • Positive predictive / negative values of the tests applied

    through study completion, maximum of one year

Study Arms (1)

Healthcare Worker

Staff of the Department of Ophthalmology, University Tuebingen, Germany

Diagnostic Test: Antibody Test

Interventions

Antibody TestDIAGNOSTIC_TEST

Presence and Titer of Anti-Sars-CoV-2 Antbodies

Healthcare Worker

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Employee of the Department of Ophthalmology (at a university institution)

You may qualify if:

  • Employees of the health facility described
  • voluntary request for testing

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

COVID-19

Interventions

Antibody Formation

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunity, ActiveAdaptive ImmunityImmunityImmune System Phenomena

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2020

First Posted

June 24, 2020

Study Start

May 13, 2020

Primary Completion

June 30, 2020

Study Completion

August 1, 2020

Last Updated

June 24, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations