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Dräger COVID-19 Antigen Test Clinical Performance Study

NCT04698993 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 388

Last updated 2021-07-20

Study results available
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Summary

The study is designed to demonstrate suitability of the Dräger Antigen Test for SARS-CoV-2 detection in clinical nasal specimens. Real-time polymerase chain reaction (RT-PCR) on specimens collected by pharyngeal swabs serves as a reference method.

Conditions

  • Covid19

Interventions

DIAGNOSTIC_TEST

Dräger Antigen Test SARS-CoV-2

Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test

Sponsors & Collaborators

  • Drägerwerk AG & Co. KGaA

    lead INDUSTRY

Principal Investigators

  • Daniel Zickler, Dr · Charite University, Berlin, Germany

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-12
Primary Completion
2021-03-22
Completion
2021-03-22

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04698993 on ClinicalTrials.gov