Trial Outcomes & Findings for COVID-19 Close Contact Self-Testing Study (NCT NCT04847479)
NCT ID: NCT04847479
Last Updated: 2025-02-03
Results Overview
Number of close contacts who test positive for COVID-19
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
8 weeks
Results posted on
2025-02-03
Participant Flow
Participant milestones
| Measure |
Self-Test Kit Distribution
Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to their close contacts.
COVID-19 self-test: Up to 3 COVID-19 self-test kits will be given to individuals who have tested positive for COVID-19. Participants will be instructed to give test kits to close contacts who have been exposed to them.
|
Test Referral Distribution
Participants in the test referral arm receive text messages providing testing information to send to their close contacts.
COVID-19 test referral: Text messages with testing information will be given to individuals who have tested positive for COVID-19. Participants will be instructed to share text messages with close contacts who have been exposed to them.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
|
Overall Study
COMPLETED
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
COVID-19 Close Contact Self-Testing Study
Baseline characteristics by cohort
| Measure |
Self-Test Kit Distribution
n=3 Participants
Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to their close contacts.
COVID-19 self-test: Up to 3 COVID-19 self-test kits will be given to individuals who have tested positive for COVID-19. Participants will be instructed to give test kits to close contacts who have been exposed to them.
|
Test Referral Distribution
Participants in the test referral arm receive text messages providing testing information to send to their close contacts.
COVID-19 test referral: Text messages with testing information will be given to individuals who have tested positive for COVID-19. Participants will be instructed to share text messages with close contacts who have been exposed to them.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
—
|
3 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
33 years
n=99 Participants
|
—
|
33 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
—
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
—
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=99 Participants
|
—
|
3 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: We were unable to recruit any participants in the test referral arm who tested positive.
Number of close contacts who test positive for COVID-19
Outcome measures
| Measure |
Self-Test Kit Distribution
n=3 Participants
Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to their close contacts.
COVID-19 self-test: Up to 3 COVID-19 self-test kits will be given to individuals who have tested positive for COVID-19. Participants will be instructed to give test kits to close contacts who have been exposed to them.
|
Test Referral Distribution
Participants in the test referral arm receive text messages providing testing information to send to their close contacts.
COVID-19 test referral: Text messages with testing information will be given to individuals who have tested positive for COVID-19. Participants will be instructed to share text messages with close contacts who have been exposed to them.
|
|---|---|---|
|
Number of Positive Contacts
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through study completion, up to one yearPopulation: We were unable to recruit any participants in the test referral arm who tested positive.
Number of close contacts who test positive for COVID-19 by the end of the study
Outcome measures
| Measure |
Self-Test Kit Distribution
n=3 Participants
Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to their close contacts.
COVID-19 self-test: Up to 3 COVID-19 self-test kits will be given to individuals who have tested positive for COVID-19. Participants will be instructed to give test kits to close contacts who have been exposed to them.
|
Test Referral Distribution
Participants in the test referral arm receive text messages providing testing information to send to their close contacts.
COVID-19 test referral: Text messages with testing information will be given to individuals who have tested positive for COVID-19. Participants will be instructed to share text messages with close contacts who have been exposed to them.
|
|---|---|---|
|
Number of Positive Contacts (End of Study)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: We were unable to recruit any participants in the test referral arm who tested positive.
Number of close contacts who completed a test
Outcome measures
| Measure |
Self-Test Kit Distribution
n=3 Participants
Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to their close contacts.
COVID-19 self-test: Up to 3 COVID-19 self-test kits will be given to individuals who have tested positive for COVID-19. Participants will be instructed to give test kits to close contacts who have been exposed to them.
|
Test Referral Distribution
Participants in the test referral arm receive text messages providing testing information to send to their close contacts.
COVID-19 test referral: Text messages with testing information will be given to individuals who have tested positive for COVID-19. Participants will be instructed to share text messages with close contacts who have been exposed to them.
|
|---|---|---|
|
Number of Contacts Tested
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Through study completion, up to one yearPopulation: We were unable to recruit any participants in the test referral arm who tested positive.
Number of close contacts who completed a test by the end of the study
Outcome measures
| Measure |
Self-Test Kit Distribution
n=3 Participants
Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to their close contacts.
COVID-19 self-test: Up to 3 COVID-19 self-test kits will be given to individuals who have tested positive for COVID-19. Participants will be instructed to give test kits to close contacts who have been exposed to them.
|
Test Referral Distribution
Participants in the test referral arm receive text messages providing testing information to send to their close contacts.
COVID-19 test referral: Text messages with testing information will be given to individuals who have tested positive for COVID-19. Participants will be instructed to share text messages with close contacts who have been exposed to them.
|
|---|---|---|
|
Number of Contacts Tested (End of Study)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: We were unable to recruit any participants in the test referral arm who tested positive.
Number of household contacts who completed a test
Outcome measures
| Measure |
Self-Test Kit Distribution
n=3 Participants
Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to their close contacts.
COVID-19 self-test: Up to 3 COVID-19 self-test kits will be given to individuals who have tested positive for COVID-19. Participants will be instructed to give test kits to close contacts who have been exposed to them.
|
Test Referral Distribution
Participants in the test referral arm receive text messages providing testing information to send to their close contacts.
COVID-19 test referral: Text messages with testing information will be given to individuals who have tested positive for COVID-19. Participants will be instructed to share text messages with close contacts who have been exposed to them.
|
|---|---|---|
|
Number of Household Contacts Tested
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through study completion, up to one yearPopulation: We were unable to recruit any participants in the test referral arm who tested positive.
Number of household contacts who completed a test by the end of the study
Outcome measures
| Measure |
Self-Test Kit Distribution
n=3 Participants
Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to their close contacts.
COVID-19 self-test: Up to 3 COVID-19 self-test kits will be given to individuals who have tested positive for COVID-19. Participants will be instructed to give test kits to close contacts who have been exposed to them.
|
Test Referral Distribution
Participants in the test referral arm receive text messages providing testing information to send to their close contacts.
COVID-19 test referral: Text messages with testing information will be given to individuals who have tested positive for COVID-19. Participants will be instructed to share text messages with close contacts who have been exposed to them.
|
|---|---|---|
|
Number of Household Contacts Tested (End of Study)
|
0 Participants
|
0 Participants
|
Adverse Events
Self-Test Kit Distribution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Test Referral Distribution
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