Trial Outcomes & Findings for Dräger COVID-19 Antigen Test Clinical Performance Study (NCT NCT04698993)

NCT ID: NCT04698993

Last Updated: 2021-07-20

Results Overview

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)

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

388 participants

Primary outcome timeframe

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

Results posted on

2021-07-20

Participant Flow

Participant milestones

Participant milestones
Measure	Symptomatic Collection of specimens from symptomatic COVID-19 positive participants Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test	Asymptomatic Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2 Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test
Overall Study STARTED	275	113
Overall Study COMPLETED	272	106
Overall Study NOT COMPLETED	3	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Symptomatic Collection of specimens from symptomatic COVID-19 positive participants Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test	Asymptomatic Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2 Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test
Overall Study PCR results not accessible	2	7
Overall Study incomplete documentation of kit assessment prior to testing	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Symptomatic n=275 Participants Collection of specimens from symptomatic COVID-19 positive participants Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test	Asymptomatic n=113 Participants Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2 Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test	Total n=388 Participants Total of all reporting groups
Age, Continuous	34.6 years n=275 Participants	32.5 years n=113 Participants	34.0 years n=388 Participants
Sex: Female, Male Female	145 Participants n=275 Participants	66 Participants n=113 Participants	211 Participants n=388 Participants
Sex: Female, Male Male	130 Participants n=275 Participants	47 Participants n=113 Participants	177 Participants n=388 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Germany	275 participants n=275 Participants	113 participants n=113 Participants	388 participants n=388 Participants

PRIMARY outcome

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

Population: 8 symptomatic participants with low RNA copy number were excluded for the calculation of the primary endpoint As this endpoint only considers the sensitivity in symptomatic participants, no numbers are shown for the asymptomatic group

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)

Outcome measures

Outcome measures
Measure	Symptomatic n=264 Participants Collection of specimens from symptomatic COVID-19 positive participants Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test	Asymptomatic Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2 Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test
Sensitivity	96.7 percentage of true cases Interval 88.8 to 99.1	—

PRIMARY outcome

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

Population: 8 symptomatic participants were excluded due to low RNA copy number As this endpoint only considers the specificity in symptomatic participants, no numbers are shown for the asymptomatic group

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)

Outcome measures

Outcome measures
Measure	Symptomatic n=264 Participants Collection of specimens from symptomatic COVID-19 positive participants Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test	Asymptomatic Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2 Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test
Specificity	99.5 percentage of true negative cases Interval 97.3 to 99.9	—

SECONDARY outcome

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

Population: For the calculation of this endpoint only the PCR-positive participants from the symptomatic group were counted.

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

Outcome measures

Outcome measures
Measure	Symptomatic n=69 Participants Collection of specimens from symptomatic COVID-19 positive participants Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test	Asymptomatic Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2 Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test
Sensitivity in Relation to the Cycle Threshold Value of the Reference RT-PCR (in the Symptomatic Group)	97.8 percentage of true positive cases Interval 88.7 to 99.6	—

SECONDARY outcome

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

Population: For the calculation of this endpoint only the PCR-positive participants from the symptomatic group were counted.

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

Outcome measures

Outcome measures
Measure	Symptomatic n=69 Participants Collection of specimens from symptomatic COVID-19 positive participants Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test	Asymptomatic Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2 Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test
Sensitivity in Relation to the Time Since Symptom Onset (in the Symptomatic Group)	90.9 percentage of true positive cases Interval 80.4 to 96.1	—

SECONDARY outcome

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

Population: For the calculation of this endpoint only the PCR-negative participants from the asymptomatic group were counted.

Specificity of the antigen test in at least 100 asymptomatic participants

Outcome measures

Outcome measures
Measure	Symptomatic Collection of specimens from symptomatic COVID-19 positive participants Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test	Asymptomatic n=105 Participants Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2 Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test
Specificity in Asymptomatic Participants	—	100 percentage of true negative cases Interval 96.5 to 100.0

SECONDARY outcome

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

Record of occurrence of lasting nosebleed or unbearable pain during or immediately after specimen collection

Outcome measures

Outcome measures
Measure	Symptomatic n=275 Participants Collection of specimens from symptomatic COVID-19 positive participants Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test	Asymptomatic n=113 Participants Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2 Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test
Frequency of Nosebleed or Unbearable Pain During or Immediately After Specimen Collection	0 Participants	0 Participants

Adverse Events

Symptomatic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Asymptomatic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Rainer Polzius

Draegerwerk AG & Co. KGaA

Phone: +498824514429

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place