NCT04716088

Brief Summary

Physicians, nurses and hospital attendants currently working at the University Clinic of Respiratory and Allergic Diseases Golnik were invited to participate in the pilot study. Nasopharyngeal swabs were obtained three times per week for two consecutive weeks and tested with a point-of-care rapid antigen test and reverse transcription polymerase chain reaction (RT-PCR). In addition, serum samples were obtained at the beginning of the study and 2 weeks after last swab was obtained in order to evaluate the serological status of participating health care workers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 18, 2020

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2020

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2020

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

14 days

First QC Date

January 15, 2021

Last Update Submit

January 20, 2021

Conditions

SARS-CoV-2 Rapid Antigen Test

Outcome Measures

Primary Outcomes (1)

  • SARS CoV2 infection

    positive rapid antigen test for SARS CoV2

    14 days

Interventions

Rapid antigen test for SARS CoV2DIAGNOSTIC_TEST

Defining diagnostic performance of repeated testing regimen in hospital setting

Eligibility Criteria

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

Physicians, nurses and hospital attendants currently working at the University Clinic of Respiratory and Allergic Diseases Golnik were invited to enroll in the pilot study.

You may qualify if:

  • health care worker

You may not qualify if:

  • previous known COVID 19 infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitiy Clinic for respiratory and allergic diseases

Golnik, 4204, Slovenia

Location

Related Publications (2)

  • Jakobsen KK, Jensen JS, Todsen T, Tolsgaard MG, Kirkby N, Lippert F, Vangsted AM, Martel CJ, Klokker M, von Buchwald C. Accuracy and cost description of rapid antigen test compared with reverse transcriptase-polymerase chain reaction for SARS-CoV-2 detection. Dan Med J. 2021 Jun 14;68(7):A03210217.

    PMID: 34169830DERIVED

  • Sterbenc A, Tomic V, Bidovec Stojkovic U, Vrankar K, Rozman A, Zidarn M. Usefulness of rapid antigen testing for SARS-CoV-2 screening of healthcare workers: a pilot study. Clin Exp Med. 2022 Feb;22(1):157-160. doi: 10.1007/s10238-021-00722-y. Epub 2021 May 22.

    PMID: 34021827DERIVED

Study Officials

  • Mihaela Zidarn, MD PhD

    Klinika Golnik

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 15, 2021

First Posted

January 20, 2021

Study Start

November 18, 2020

Primary Completion

December 2, 2020

Study Completion

December 22, 2020

Last Updated

January 22, 2021

Record last verified: 2021-01

Locations

SL(1)