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The study register has recently been expanded to include the category “COVID-19”. For the first time, not only DZIF study activities are presented here: In order to provide a comprehensive overview in the current pandemic situation of planned and already active COVID-19 studies in Germany, the Clinical Trial Unit is cooperating with researchers from various German Centers for Health Research and other networks.

For researchers: If your study is not yet included in our portal, please contact the project management of the Clinical Trial Unit (angela.steinbach@uk-koeln.de or vassiliki.dimitriou@uk-koeln.de).

Antigen POC Tests COVID-19

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
DRKS00021220

Evaluation of the performance of novel rapid diagnostics for SARS-CoV-2 at point-of-care

Status: Active

Purpose / Objectives

Primary Outcome

To determine the diagnostic accuracy of COVID-19 antigen tests on a respiratory specimen (NP swab, OP swab), vs gold-standard real-time reverse-transcription PCR (RT-PCR), as performed in an affiliated reference laboratory on a respiratory specimen.

Diagnosis

Patient attributes

Inclusion criteria

  • Patients with suspected SARS-CoV-2 infection, age >18
  • Participants included will meet testing criteria as determined by the Department of Public Health.

 

Trial design

  • Prospective

Intervention

This is a prospective study for diagnostic accuracy. The different test will be evaluated in substudies.

The same study design will be applied to each test evaluation (substudy) performed under this protocol.

Each substudy is a separate diagnostic accuracy study, with the primary objective of validating the performance of a novel rapid POC SARS-CoV-2 test in patients with suspected COVID-19 presenting to be tested at the testing sites.

We will enroll at least 500 participants and a maximum of 2,000 participants suspected to have COVID-19 at all sites per each substudy. At least 2,000 participants with a maximum of 5,000 participants in total.

Documents (password protected)

Responsibilities in overall trial

Ruprecht-Karls-Universität Heidelberg

National Coordinating Investigator

Dr. med. Claudia Denkinger