Trial Outcomes & Findings for Assessing Testing Strategies for Safe Return to K-12 Schools in an Underserved Population (NCT NCT04875520)
NCT ID: NCT04875520
Last Updated: 2026-06-29
Results Overview
The rate of all new COVID-19 cases of student/staff in schools per randomization group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1390 participants
Primary outcome timeframe
Up to one year.
Results posted on
2026-06-29
Participant Flow
All students, staff, and family members from 16 middle and high schools were eligible to participate.
1390 individuals from 16 middle and high schools were enrolled.
Unit of analysis: schools
Participant milestones
| Measure |
Weekly Screening Testing Plus Symptomatic Testing
Among 16 middle and high schools, 8 will be randomized to offer students and staff weekly SARS-CoV-2 testing. Additionally, these schools will offer testing for symptomatic students, staff, household members in all age groups.
Screening testing strategy: The intervention we are evaluating is the use of weekly screening testing among students and staff.
|
Symptomatic Testing
All 16 schools will have testing available for individuals that have symptoms or need a test for other reasons.
No screening testing strategy: a group of schools will not receive screening testing.
|
|---|---|---|
|
Overall Study
STARTED
|
894 8
|
496 8
|
|
Overall Study
COMPLETED
|
797 8
|
460 8
|
|
Overall Study
NOT COMPLETED
|
97 0
|
36 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Missing data
Baseline characteristics by cohort
| Measure |
Weekly Screening Testing Plus Symptomatic Testing
n=894 Participants
Among 16 middle and high schools, 8 will be randomized to offer students and staff weekly SARS-CoV-2 testing. Additionally, these schools will offer testing for symptomatic students, staff, household members in all age groups.
Screening testing strategy: The intervention we are evaluating is the use of weekly screening testing among students and staff.
|
Symptomatic Testing
n=496 Participants
All 16 schools will have testing available for individuals that have symptoms or need a test for other reasons.
No screening testing strategy: a group of schools will not receive screening testing.
|
Total
n=1390 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
n=894 Participants
|
30 years
n=496 Participants
|
35 years
n=1390 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
530 Participants
n=894 Participants
|
299 Participants
n=496 Participants
|
829 Participants
n=1390 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
310 Participants
n=894 Participants
|
175 Participants
n=496 Participants
|
485 Participants
n=1390 Participants
|
|
Sex/Gender, Customized
Gender · Other
|
54 Participants
n=894 Participants
|
22 Participants
n=496 Participants
|
76 Participants
n=1390 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
30 Participants
n=894 Participants
|
7 Participants
n=496 Participants
|
37 Participants
n=1390 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
771 Participants
n=894 Participants
|
413 Participants
n=496 Participants
|
1184 Participants
n=1390 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
93 Participants
n=894 Participants
|
76 Participants
n=496 Participants
|
169 Participants
n=1390 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=894 Participants
|
3 Participants
n=496 Participants
|
8 Participants
n=1390 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=894 Participants
|
0 Participants
n=496 Participants
|
9 Participants
n=1390 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=894 Participants
|
0 Participants
n=496 Participants
|
0 Participants
n=1390 Participants
|
|
Race (NIH/OMB)
Black or African American
|
323 Participants
n=894 Participants
|
282 Participants
n=496 Participants
|
605 Participants
n=1390 Participants
|
|
Race (NIH/OMB)
White
|
431 Participants
n=894 Participants
|
144 Participants
n=496 Participants
|
575 Participants
n=1390 Participants
|
|
Race (NIH/OMB)
More than one race
|
47 Participants
n=894 Participants
|
31 Participants
n=496 Participants
|
78 Participants
n=1390 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
79 Participants
n=894 Participants
|
36 Participants
n=496 Participants
|
115 Participants
n=1390 Participants
|
|
Participant Type
Staff
|
353 Participants
n=843 Participants • Missing data
|
203 Participants
n=469 Participants • Missing data
|
556 Participants
n=1312 Participants • Missing data
|
|
Participant Type
Student
|
200 Participants
n=843 Participants • Missing data
|
183 Participants
n=469 Participants • Missing data
|
383 Participants
n=1312 Participants • Missing data
|
|
Participant Type
Household
|
290 Participants
n=843 Participants • Missing data
|
83 Participants
n=469 Participants • Missing data
|
373 Participants
n=1312 Participants • Missing data
|
|
Received COVID-19 Vaccine
Yes
|
509 Participants
n=894 Participants
|
252 Participants
n=496 Participants
|
761 Participants
n=1390 Participants
|
|
Received COVID-19 Vaccine
No
|
170 Participants
n=894 Participants
|
142 Participants
n=496 Participants
|
312 Participants
n=1390 Participants
|
|
Received COVID-19 Vaccine
Other
|
215 Participants
n=894 Participants
|
102 Participants
n=496 Participants
|
317 Participants
n=1390 Participants
|
|
Social Vulnerability Index
Low
|
293 Participants
n=875 Participants • Missing data
|
120 Participants
n=491 Participants • Missing data
|
413 Participants
n=1366 Participants • Missing data
|
|
Social Vulnerability Index
Low-Medium
|
128 Participants
n=875 Participants • Missing data
|
67 Participants
n=491 Participants • Missing data
|
195 Participants
n=1366 Participants • Missing data
|
|
Social Vulnerability Index
Medium - High
|
331 Participants
n=875 Participants • Missing data
|
197 Participants
n=491 Participants • Missing data
|
528 Participants
n=1366 Participants • Missing data
|
|
Social Vulnerability Index
High
|
123 Participants
n=875 Participants • Missing data
|
107 Participants
n=491 Participants • Missing data
|
230 Participants
n=1366 Participants • Missing data
|
PRIMARY outcome
Timeframe: Up to one year.Population: The unit analyzed were the number of the tests completed overall during the study.
The rate of all new COVID-19 cases of student/staff in schools per randomization group.
Outcome measures
| Measure |
Weekly Screening Testing Plus Symptomatic Testing
n=6436 Completed tests
Total reported school cases during study period divided by school population.
|
Symptomatic Testing
n=7488 Completed tests
Total reported school cases during study period divided by school population.
|
|---|---|---|
|
Overall Rate of All COVID-19 Cases in Schools.
|
453 Completed tests
|
297 Completed tests
|
Adverse Events
Weekly Screening Testing Plus Symptomatic Testing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Symptomatic Testing
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