Trial Outcomes & Findings for COVID-19 MP Biomedicals Rapid SARS-CoV-2 Antigen Test Usability (NCT NCT05584189)
NCT ID: NCT05584189
Last Updated: 2023-06-02
Results Overview
Lay subjects aged 14-65+ who will perform collection of the candidate Ag self-test kit on themselves under the supervision of qualified site personnel in person.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
99 participants
Primary outcome timeframe
One Hour
Results posted on
2023-06-02
Participant Flow
Participant milestones
| Measure |
Participants Who Test Themselves
Participants between the ages of 14-65+ years will perform candidate Ag self-test kit anterior nasal specimen collection and testing under the supervision of qualified site personnel in person.
Rapid SARS-CoV-2 Antigen Test: Candidate Ag self-test kit anterior nasal specimen collection and testing will be done under the supervision of qualified site personnel in person.
|
Participants Who Test Another Participant
Participants between the ages of 18-65+ years will perform candidate Ag self-test kit anterior nasal specimen collection on another participant aged 2-65+ years and testing of the candidate Ag self-test kit under the supervision of qualified site personnel in person.
Rapid SARS-CoV-2 Antigen Test: Candidate Ag self-test kit anterior nasal specimen collection and testing will be done under the supervision of qualified site personnel in person.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
46
|
|
Overall Study
COMPLETED
|
53
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
COVID-19 MP Biomedicals Rapid SARS-CoV-2 Antigen Test Usability
Baseline characteristics by cohort
| Measure |
At Least 30 Persons 14-65+ Years of Age Who Test Themselves
n=53 Participants
Participants between the ages of 14-65+ years will perform candidate Ag self-test kit anterior nasal specimen collection and testing under the supervision of qualified site personnel in person.
Rapid SARS-CoV-2 Antigen Test: Candidate Ag self-test kit anterior nasal specimen collection and testing will be done under the supervision of qualified site personnel in person.
|
At Least 30 Persons 18-65+ Years of Age Who Test Another Participant
n=46 Participants
Participants between the ages of 18-65+ years will perform candidate Ag self-test kit anterior nasal specimen collection on another participant aged 2-65+ years and testing of the candidate Ag self-test kit under the supervision of qualified site personnel in person.
Rapid SARS-CoV-2 Antigen Test: Candidate Ag self-test kit anterior nasal specimen collection and testing will be done under the supervision of qualified site personnel in person.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One HourPopulation: The second arm of the trial was analyzed under the second primary outcome measure. This is why the number is 0 for this outcome measure.
Lay subjects aged 14-65+ who will perform collection of the candidate Ag self-test kit on themselves under the supervision of qualified site personnel in person.
Outcome measures
| Measure |
At Least 30 Persons 14-65+ Years of Age Who Test Themselves
n=53 Participants
Participants between the ages of 14-65+ years will perform candidate Ag self-test kit anterior nasal specimen collection and testing under the supervision of qualified site personnel in person.
Rapid SARS-CoV-2 Antigen Test: Candidate Ag self-test kit anterior nasal specimen collection and testing will be done under the supervision of qualified site personnel in person.
|
At Least 30 Persons 18-65+ Years of Age Who Test Another Participant
Participants between the ages of 18-65+ years will perform candidate Ag self-test kit anterior nasal specimen collection on another participant aged 2-65+ years and testing of the candidate Ag self-test kit under the supervision of qualified site personnel in person.
Rapid SARS-CoV-2 Antigen Test: Candidate Ag self-test kit anterior nasal specimen collection and testing will be done under the supervision of qualified site personnel in person.
|
|---|---|---|
|
30 Candidate Ag Test Self-collections
|
53 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: One HourPopulation: The first arm of the trial was analyzed under the first primary outcome measure. This is why the number is 0 for this outcome measure.
Lay subjects aged 18-65+ who will perform collection of the candidate Ag self-test kit on another participant aged 2-65+ years under the supervision of qualified site personnel in person
Outcome measures
| Measure |
At Least 30 Persons 14-65+ Years of Age Who Test Themselves
Participants between the ages of 14-65+ years will perform candidate Ag self-test kit anterior nasal specimen collection and testing under the supervision of qualified site personnel in person.
Rapid SARS-CoV-2 Antigen Test: Candidate Ag self-test kit anterior nasal specimen collection and testing will be done under the supervision of qualified site personnel in person.
|
At Least 30 Persons 18-65+ Years of Age Who Test Another Participant
n=46 Participants
Participants between the ages of 18-65+ years will perform candidate Ag self-test kit anterior nasal specimen collection on another participant aged 2-65+ years and testing of the candidate Ag self-test kit under the supervision of qualified site personnel in person.
Rapid SARS-CoV-2 Antigen Test: Candidate Ag self-test kit anterior nasal specimen collection and testing will be done under the supervision of qualified site personnel in person.
|
|---|---|---|
|
30 Candidate Ag Test Collections of Another
|
0 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: One HourAt least one lay subject aged 14-65+ who will perform collection of the candidate Ag self-test kit on themselves under the supervision of qualified site personnel in person and/or at least one lay subject aged 18-65+ who will perform collection of the candidate Ag self-test kit on another participant aged 2-65+ years under the supervision of qualified site personnel in person.
Outcome measures
| Measure |
At Least 30 Persons 14-65+ Years of Age Who Test Themselves
n=53 Participants
Participants between the ages of 14-65+ years will perform candidate Ag self-test kit anterior nasal specimen collection and testing under the supervision of qualified site personnel in person.
Rapid SARS-CoV-2 Antigen Test: Candidate Ag self-test kit anterior nasal specimen collection and testing will be done under the supervision of qualified site personnel in person.
|
At Least 30 Persons 18-65+ Years of Age Who Test Another Participant
n=46 Participants
Participants between the ages of 18-65+ years will perform candidate Ag self-test kit anterior nasal specimen collection on another participant aged 2-65+ years and testing of the candidate Ag self-test kit under the supervision of qualified site personnel in person.
Rapid SARS-CoV-2 Antigen Test: Candidate Ag self-test kit anterior nasal specimen collection and testing will be done under the supervision of qualified site personnel in person.
|
|---|---|---|
|
At Least One Enrollment of a Spanish Speaking Lay User
|
3 Participants
|
0 Participants
|
Adverse Events
At Least 30 Persons 14-65+ Years of Age Who Test Themselves
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
At Least 30 Persons 18-65+ Years of Age Who Test Another Participant
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place