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

NCT05074017 | Completed FDA Device

• 1 other identifier: COVAG study protocol 2.0
• Study Type: observational
• Target: 2,222
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19; SARS-CoV2 Infection; SARS (Disease)

Outcome Measures

Primary Outcomes (1)

• Sensitivity of the rapid antigen tests

  31.03.2021

Interventions

3 nasopharyngeal swab DEVICE

3 nasopharyngeal swabs to conduct 2 rapid antigen tests for SARS-CoV-2 and a RT-PCR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Age 18 years or more

You may not qualify if:

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

Sponsors & Collaborators

• Synlab Holding Deutschland GmbH: lead

Study Sites (2)

SYNLAB MVZ Leinfelden-Echterdingen GmbH

Leinfelden-Echterdingen, Germany

Location

Corona Testzentrum Cannstatter Wasen

Stuttgart, Germany

Location

Related Publications (1)

• Stocking C, de Miguel L, Suteu G, Dressel A, Soricelli A, Roskos M, Valor S, Mutschmann C, Marz W. Evaluation of five widely used serologic assays for antibodies to SARS-CoV-2. Diagn Microbiol Infect Dis. 2022 Feb;102(2):115587. doi: 10.1016/j.diagmicrobio.2021.115587. Epub 2021 Oct 29.

  PMID: 34826767 BACKGROUND

Related Links

• Cohen, J. (1988). Statistical Power Analysis for the Behavioral Sciences. New York: Routledge,

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome; Disease

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Winfried März, Prof. Dr. med

  Synlab Holding Deutschland GmbH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctorate student (of Prof. Dr. med. Winfried März, Medical faculty Mannheim)

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 12, 2021
• Study Start: February 1, 2021
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

DE (2)