Covid19NCT04698993
Dräger COVID-19 Antigen Test Clinical Performance Study
A study testing Dräger Antigen Test SARS-CoV-2 in people with Covid19, run by Drägerwerk AG & Co. KGaA at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Dräger Antigen Test SARS-CoV-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 1 siteGermany
- Study dates
- 12 Feb 2021to 22 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dräger Antigen Test SARS-CoV-2 Clinical Performance Study
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.
Read the detailed description
The Dräger Antigen Test SARS-CoV-2 is a rapid lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleoprotein directly from less invasive nasal swabs, to be performed at the point of care. The test kit contains all components required to carry out a test detecting SARS-CoV-2 nucleoprotein.
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.
The goal of the study is to compare Dräger test results to the corresponding PCR data for overall sensitivity and specificity. Specimens are collected from patients showing COVID-19 symptoms as well as asymptomatic participants. Participants are recruited across all genders and eligible age groups. Study staff records participants' information such as symptoms and time since symptom onset. For each study participant, the specimen for RT-PCR is collected first, then the Dräger test specimen. The Dräger test result is read after 15 min to 20 min.
- Conditions
- Covid19
- Being tested
- Dräger Antigen Test SARS-CoV-2
- Keywords
- antigen test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dräger Antigen Test SARS-CoV-2Diagnostic test
Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic | Other | Collection of specimens from symptomatic COVID-19 positive participants Receives: 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 Receives: Diagnostic Test: Dräger Antigen Test SARS-CoV-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Description of relationship between cycle threshold value of the reference RT-PCR and Dräger test performance.
Presented is the sensitivity(true positive rate) in the symptomatic group at a cycle threshold of <22
Measured: Through study completion, an average of 1 1/2 month
Sensitivity in Relation to the Time Since Symptom Onset (in the Symptomatic Group)
Description of relationship between days since symptom onset and Dräger test performance.
Presented is the sensitivity(true positive rate) in the symptomatic group at days since symptom onset <5
Measured: Through study completion, an average of 1 1/2 month
Specificity in Asymptomatic Participants
Specificity of the antigen test in at least 100 asymptomatic participants
Measured: Through study completion, an average of 1 1/2 month
Frequency of Nosebleed or Unbearable Pain During or Immediately After Specimen Collection
Record of occurrence of lasting nosebleed or unbearable pain during or immediately after specimen collection
Measured: Through study completion, an average of 1 1/2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start12 Feb 2021
- Primary completion22 Mar 2021
- Study completion22 Mar 2021
Why it stopped: poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drägerwerk AG & Co. KGaA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Zickler, Dr, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698993
- Sponsor's protocol ID
- Dräger Antigen Test SARS-CoV-2
- Status last verified
- Jul 2021
- First submitted
- 5 Jan 2021
- Last updated
- 20 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dräger Antigen Test SARS-CoV-2 Clinical Performance Study
- ClinicalTrials.gov ID
- NCT04698993
- Acronym / sponsor ID
- Dräger Antigen Test SARS-CoV-2
- Conditions
- Covid19
- Keywords
- antigen test
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor recruitment
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Drägerwerk AG & Co. KGaAIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 22 Mar 2021 (actual)
- Study completion
- 22 Mar 2021 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Posted 25 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Dräger Antigen Test SARS-CoV-2 is a rapid lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleoprotein directly from less invasive nasal swabs, to be performed at the point of care. The test kit contains all components required to carry out a test detecting SARS-CoV-2 nucleoprotein.
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.
The goal of the study is to compare Dräger test results to the corresponding PCR data for overall sensitivity and specificity. Specimens are collected from patients showing COVID-19 symptoms as well as asymptomatic participants. Participants are recruited across all genders and eligible age groups. Study staff records participants' information such as symptoms and time since symptom onset. For each study participant, the specimen for RT-PCR is collected first, then the Dräger test specimen. The Dräger test result is read after 15 min to 20 min.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptomatic | Other | Diagnostic Test: Dräger Antigen Test SARS-CoV-2Collection of specimens from symptomatic COVID-19 positive participants |
| Asymptomatic | Other | Diagnostic Test: Dräger Antigen Test SARS-CoV-2Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must require SARS-CoV-2 testing for the following reasons:
- Participant must be of legal age and must be able to understand the procedure and letter of consent.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dräger Antigen Test SARS-CoV-2Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test | Diagnostic test | Asymptomatic, Symptomatic |
Primary outcome
Sensitivity
Time frame: Through study completion, an average of 1 1/2 month
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)
Specificity
Time frame: Through study completion, an average of 1 1/2 month
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)
4 secondary outcomes
Sensitivity in Relation to the Cycle Threshold Value of the Reference RT-PCR (in the Symptomatic Group)
Time frame: Through study completion, an average of 1 1/2 month
Sensitivity in Relation to the Time Since Symptom Onset (in the Symptomatic Group)
Time frame: Through study completion, an average of 1 1/2 month
Specificity in Asymptomatic Participants
Time frame: Through study completion, an average of 1 1/2 month
Frequency of Nosebleed or Unbearable Pain During or Immediately After Specimen Collection
Time frame: Through study completion, an average of 1 1/2 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Zickler, Dr principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dräger Antigen Test SARS-CoV-2 in people with Covid19, run by Drägerwerk AG & Co. KGaA at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: Through study completion, an average of 1 1/2 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.