Trial Outcomes & Findings for Communities Fighting COVID Return to School (NCT NCT05150860)

NCT ID: NCT05150860

Last Updated: 2025-01-17

Results Overview

Proportion of scheduled weekly COVID-19 tests completed when enrolled in the trial

Recruitment status

COMPLETED

Study phase

Target enrollment

852 participants

Primary outcome timeframe

through study completion, up to 21 weeks

Results posted on

2025-01-17

Participant Flow

Trial enrollment of participants occurred from mid-October 2021 through late March 2022, with COVID-19 testing occurring from November 7, 2021 to March 27, 2022; the length of possible trial participation varied from 2 to 21 weeks. Participants were recruited from the three participating middle school populations. All students and school staff at the participating schools were eligible to enroll in the trial.

Schools were excluded if they had a lower proportion of students from households receiving SNAP Program benefits and a lower proportion of underrepresented minority students compared with other schools (3 schools); had ongoing school-wide testing programs with a commercial provider (2 schools); had larger (1 school) or smaller (1 school) student populations (for matching purposes) than the remaining schools; or were geographically closer to the remaining schools (1 school).

Unit of analysis: schools

Participant milestones

Participant milestones
Measure	At-home COVID-19 Testing Weekly COVID-19 screening testing using at-home rapid antigen tests	Onsite COVID-19 Testing Weekly COVID-19 screening testing onsite at school with rapid antigen tests
Overall Study STARTED	264 1	588 2
Overall Study Students	199 1	500 2
Overall Study School Staff	65 1	88 2
Overall Study COMPLETED	264 1	588 2
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Communities Fighting COVID Return to School

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	At-home COVID-19 Testing n=264 Participants Weekly COVID-19 screening testing using at-home rapid antigen tests	Onsite COVID-19 Testing n=588 Participants Weekly COVID-19 screening testing onsite at school with rapid antigen tests	Total n=852 Participants Total of all reporting groups
Age, Continuous	20.04 years STANDARD_DEVIATION 14.18 • n=5 Participants	17.10 years STANDARD_DEVIATION 11.55 • n=7 Participants	18.01 years STANDARD_DEVIATION 12.49 • n=5 Participants
Sex/Gender, Customized Gender Identity · Man	95 Participants n=5 Participants	251 Participants n=7 Participants	346 Participants n=5 Participants
Sex/Gender, Customized Gender Identity · Woman	165 Participants n=5 Participants	325 Participants n=7 Participants	490 Participants n=5 Participants
Sex/Gender, Customized Gender Identity · Another category (transgender, genderqueer, bigender, agender)	4 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Race and ethnicity · Latinx	218 Participants n=5 Participants	500 Participants n=7 Participants	718 Participants n=5 Participants
Race/Ethnicity, Customized Race and ethnicity · Filipino, Asian, or Asian Pacific Islander	9 Participants n=5 Participants	45 Participants n=7 Participants	54 Participants n=5 Participants
Race/Ethnicity, Customized Race and ethnicity · African American/Black	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Race and ethnicity · Another race or ethnicity	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized Race and ethnicity · Non-Hispanic white	20 Participants n=5 Participants	27 Participants n=7 Participants	47 Participants n=5 Participants
Region of Enrollment United States	264 participants n=5 Participants	588 participants n=7 Participants	852 participants n=5 Participants
Primary language spoken at home Spanish	66 Participants n=5 Participants	107 Participants n=7 Participants	173 Participants n=5 Participants
Primary language spoken at home English	198 Participants n=5 Participants	481 Participants n=7 Participants	679 Participants n=5 Participants

PRIMARY outcome

Timeframe: through study completion, up to 21 weeks

Population: Student and school staff participants enrolled in the trial

Proportion of scheduled weekly COVID-19 tests completed when enrolled in the trial

Outcome measures

Outcome measures
Measure	At-home COVID-19 Testing n=264 Participants Weekly COVID-19 screening testing using at-home rapid antigen tests	Onsite COVID-19 Testing n=588 Participants Weekly COVID-19 screening testing onsite at school with rapid antigen tests
Adherence to the Weekly COVID-19 Testing Schedule	0.394 proportion of scheduled tests completed Standard Error 0.038	0.352 proportion of scheduled tests completed Standard Error 0.032

Adverse Events

At-home COVID-19 Testing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Onsite COVID-19 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

Assistant Vice President for Research Support Services

San Diego State University

Phone: (619) 594-5938

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place