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COVAG - Covid-19 Antigen Study - the Diagnostic Efficacy of SARS-CoV-2 Rapid Detection Tests (COVAG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05074017
Recruitment Status : Completed
First Posted : October 12, 2021
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
Christoph Wertenauer, Synlab Holding Deutschland GmbH

Brief Summary:

The aim of the COVAG study (Covid-19 Antigen study) is to assess the diagnostic efficacy of two of the most used rapid antigen tests (Roche & Abbott).

The study will be performed at the Corona Test Center Stuttgart Cannstatter Wasen. Approximately 2000 patients will be enrolled after having signed the Informed Consent Form (ICF). Each patient will receive 3 nasopharyngeal swabs. Two for the rapid antigen tests from Roche and Abbott and one for the RT-PCR. Furthermore an anamnesis, short clinical examination and blood draw is done. The blood is examined for SARS-CoV-2 antibodies and basic laboratory tests to be communicated to participants.


Condition or disease Intervention/treatment
COVID-19 SARS-CoV2 Infection SARS (Disease) Device: 3 nasopharyngeal swab

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Study Type : Observational
Actual Enrollment : 2222 participants
Observational Model: Other
Time Perspective: Other
Official Title: COVAG Study - Covid-19 Antigen Study
Actual Study Start Date : February 1, 2021
Actual Primary Completion Date : March 31, 2021
Actual Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: 3 nasopharyngeal swab
    3 nasopharyngeal swabs to conduct 2 rapid antigen tests for SARS-CoV-2 and a RT-PCR


Primary Outcome Measures :
  1. Sensitivity of the rapid antigen tests [ Time Frame: 31.03.2021 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
We will include approximately 2000 consecutive male and female patients aged 18 years or above attending the Corona Test Center Stuttgart Cannstadter Wasen, in whom RT- PCR testing for SARS-CoV-2 is medically indicated or requested.
Criteria

Inclusion Criteria:

  1. Signed informed consent must be obtained prior to study participation. The patient must be capable of understanding the nature, significance and implication of the trial.
  2. Age 18 years or more

Exclusion Criteria:

  1. Lack of informed consent
  2. Inability to understand the nature, significance and implication of the trial.
  3. Severe clinical conditions requiring emergency hospitalization
  4. Children and adolescents under the age of 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05074017


Locations
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Germany
SYNLAB MVZ Leinfelden-Echterdingen GmbH
Leinfelden-Echterdingen, Germany
Corona Testzentrum Cannstatter Wasen
Stuttgart, Germany
Sponsors and Collaborators
Synlab Holding Deutschland GmbH
Investigators
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Study Director: Winfried März, Prof. Dr. med Synlab Holding Deutschland GmbH
  Study Documents (Full-Text)

Documents provided by Christoph Wertenauer, Synlab Holding Deutschland GmbH:
Additional Information:
Publications:
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Responsible Party: Christoph Wertenauer, doctorate student (of Prof. Dr. med. Winfried März, Medical faculty Mannheim), Synlab Holding Deutschland GmbH
ClinicalTrials.gov Identifier: NCT05074017    
Other Study ID Numbers: COVAG study protocol 2.0
First Posted: October 12, 2021    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Data will be made available to researchers upon request and formal agreement formal agreement to make sure that rules of good scientific practice are obeyed and that credit is given to the people who have been in charge of the design and the organization of the study. Interested researchers are invited to address their request or proposal to Prof. Dr. med. Winfried März (Winfried.Maerz@synlab.com).

Finally, the authors confirm that they accessed and validated these data and that all other researchers can access the data in the same manner the authors did.

Supporting Materials: Study Protocol
URL: https://www.synlab.de/fileadmin/pdf/news/covag-covid-antigentest-studienprotokoll-synlab-english.pdf

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases