Dräger COVID-19 Antigen Test Clinical Performance Study

NCT04698993 | Terminated Results

• 1 other identifier: Dräger Antigen Test SARS-CoV-2
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

antigen test

Outcome Measures

Primary Outcomes (2)

• Sensitivity

  Sensitivity (true positive rate) of antigen test in symptomatic participants compared with reference standard PCR test (at a threshold of \>=10\^6 RNA copies/ml for positive PCR results)

  Through study completion, an average of 1 1/2 month

• Specificity

  Specificity (true negative rate) of antigen test in symptomatic participants compared with reference standard PCR test (at a threshold of \>=10\^6 RNA copies/ml for positive PCR results)

  Through study completion, an average of 1 1/2 month

Secondary Outcomes (4)

• Sensitivity in Relation to the Cycle Threshold Value of the Reference RT-PCR (in the Symptomatic Group)

  Through study completion, an average of 1 1/2 month

• Sensitivity in Relation to the Time Since Symptom Onset (in the Symptomatic Group)

  Through study completion, an average of 1 1/2 month

• Specificity in Asymptomatic Participants

  Through study completion, an average of 1 1/2 month

• Frequency of Nosebleed or Unbearable Pain During or Immediately After Specimen Collection

  Through study completion, an average of 1 1/2 month

Study Arms (2)

Symptomatic

OTHER

Collection of specimens from symptomatic COVID-19 positive participants

Diagnostic Test: Dräger Antigen Test SARS-CoV-2

Asymptomatic

OTHER

Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2

Diagnostic Test: Dräger Antigen Test SARS-CoV-2

Interventions

Dräger Antigen Test SARS-CoV-2 DIAGNOSTIC_TEST

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

Asymptomatic; Symptomatic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must require SARS-CoV-2 testing for the following reasons:
• COVID-19 symptoms (Fever, cough and/or sore throat, fatigue/ general feeling of weakness, loss of sense of smell and/or taste, shortness of breath, muscle stiffness/ body aches, head cold/ running nose, etc.) on the day of testing, or
• Known or suspected exposure to SARS-CoV-2 (contact persons etc.), or
• Member of a group of high risk of exposure such as healthcare workers etc., or
• Require screening for any other reason, e.g. doctor's orders, hygiene directive etc.
• Participant must be of legal age and must be able to understand the procedure and letter of consent.

You may not qualify if:

• Patients younger than 18 years old are excluded from the study.
• Pregnant or breastfeeding patients are excluded from the study.
• Patients unable to provide written informed consent are excluded.
• Patients with bleeding disorder are excluded from the study as a precaution.
• Hospitalized patients/inpatients are excluded.
• Application of nasal spray within 15 min prior to testing.
• Participants with symptoms on the day of testing are excluded, if any of their symptoms started more than 14 days prior to testing.
• Asymptomatic participants are excluded, if they experienced any symptoms in the 14 days prior to testing.

Sponsors & Collaborators

• Drägerwerk AG & Co. KGaA: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

COVID-19

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

Results Point of Contact

• Title: Dr Rainer Polzius
• Organization: Draegerwerk AG & Co. KGaA

rainer.polzius@draeger.com

+498824514429

Study Officials

• Daniel Zickler, Dr

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 7, 2021
• Study Start: February 12, 2021
• Primary Completion: March 22, 2021
• Study Completion: March 22, 2021
• Last Updated: July 20, 2021
• Results First Posted: June 25, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)