Trial Outcomes & Findings for Testing for COVID-19 in High Risk Children With Intellectual and Developmental Disabilities (COV-IDD) (NCT NCT04887129)

NCT ID: NCT04887129

Last Updated: 2025-02-03

Results Overview

Number of students or staff who test positive for COVID-19 at least once using a nasal swab test.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 392 participants
• Primary outcome timeframe: 16 months
• Results posted on: 2025-02-03

Participant Flow

Participant milestones

Measure	Students All students enrolled at the Mary Cariola Center in Rochester, NY. All staff working at the Mary Cariola Center in Rochester, NY.	Staff All students enrolled at the Mary Cariola Center in Rochester, NY. All staff working at the Mary Cariola Center in Rochester, NY.
Overall Study STARTED	59	333
Overall Study COMPLETED	48	243
Overall Study NOT COMPLETED	11	90

Reasons for withdrawal

Measure	Students All students enrolled at the Mary Cariola Center in Rochester, NY. All staff working at the Mary Cariola Center in Rochester, NY.	Staff All students enrolled at the Mary Cariola Center in Rochester, NY. All staff working at the Mary Cariola Center in Rochester, NY.
Overall Study Lost to Follow-up	0	24
Overall Study Withdrawal by Subject	9	57
Overall Study Other	2	9

Baseline Characteristics

Sex data was missing for 14 students and 44 staff.

Baseline characteristics by cohort

Measure	Students n=59 Participants All students enrolled at the Mary Cariola Center in Rochester, NY. All staff working at the Mary Cariola Center in Rochester, NY.	Staff n=333 Participants All students enrolled at the Mary Cariola Center in Rochester, NY. All staff working at the Mary Cariola Center in Rochester, NY.	Total n=392 Participants Total of all reporting groups
Age, Continuous	10 years n=59 Participants	33 years n=333 Participants	NA years n=392 Participants
Sex: Female, Male Female	14 Participants n=45 Participants • Sex data was missing for 14 students and 44 staff.	253 Participants n=289 Participants • Sex data was missing for 14 students and 44 staff.	267 Participants n=334 Participants • Sex data was missing for 14 students and 44 staff.
Sex: Female, Male Male	31 Participants n=45 Participants • Sex data was missing for 14 students and 44 staff.	36 Participants n=289 Participants • Sex data was missing for 14 students and 44 staff.	67 Participants n=334 Participants • Sex data was missing for 14 students and 44 staff.
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=59 Participants	14 Participants n=333 Participants	17 Participants n=392 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=59 Participants	274 Participants n=333 Participants	315 Participants n=392 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	15 Participants n=59 Participants	45 Participants n=333 Participants	60 Participants n=392 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=59 Participants	2 Participants n=333 Participants	4 Participants n=392 Participants
Race (NIH/OMB) Asian	1 Participants n=59 Participants	8 Participants n=333 Participants	9 Participants n=392 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=59 Participants	0 Participants n=333 Participants	0 Participants n=392 Participants
Race (NIH/OMB) Black or African American	8 Participants n=59 Participants	38 Participants n=333 Participants	46 Participants n=392 Participants
Race (NIH/OMB) White	32 Participants n=59 Participants	225 Participants n=333 Participants	257 Participants n=392 Participants
Race (NIH/OMB) More than one race	2 Participants n=59 Participants	8 Participants n=333 Participants	10 Participants n=392 Participants
Race (NIH/OMB) Unknown or Not Reported	14 Participants n=59 Participants	52 Participants n=333 Participants	66 Participants n=392 Participants
Region of Enrollment United States	59 participants n=59 Participants	333 participants n=333 Participants	392 participants n=392 Participants

PRIMARY outcome

Timeframe: 16 months

Population: 12 staff members did not have a valid test for COVID

Number of students or staff who test positive for COVID-19 at least once using a nasal swab test.

Outcome measures

Measure	Students n=59 Participants All students enrolled at the Mary Cariola Center in Rochester, NY.	Staff n=321 Participants All students enrolled at the Mary Cariola Center in Rochester, NY.
Number Infected With COVID-19	29 Participants	141 Participants

PRIMARY outcome

Timeframe: baseline to 16 months

Population: 29 students did not have data collected at 16 months. 165 adults did not have data collected at 16 months.

Anxiety will be measured using the PROMIS-29 assessment. Participants were classified within normal range, mild, moderate or severe. They were counted as having anxiety if they were moderate or severe.

Outcome measures

Measure	Students n=30 Participants All students enrolled at the Mary Cariola Center in Rochester, NY.	Staff n=168 Participants All students enrolled at the Mary Cariola Center in Rochester, NY.
Change in the Percentage of Participants Reporting Anxiety	11.7 percentage of participants	-0.7 percentage of participants

PRIMARY outcome

Timeframe: baseline to 16 months

Population: 29 students did not have data collected at 16 months. 165 adults did not have data collected at 16 months.

Depression was measured using the PROMIS-29 assessment. Students or staff were classified within normal range, mild, moderate or severe. They were counted as having depression if they were moderate or severe.

Outcome measures

Measure	Students n=30 Participants All students enrolled at the Mary Cariola Center in Rochester, NY.	Staff n=168 Participants All students enrolled at the Mary Cariola Center in Rochester, NY.
Change in the Percentage of Participants Classified as Depressed	-0.8 percentage of participants	3.5 percentage of participants

PRIMARY outcome

Timeframe: baseline to 16 months

Population: 29 students did not have data collected at 16 months. 165 adults did not have data collected at 16 months.

Fatigue will be measured using the PROMIS-29 assessment. Participants were classified within normal range, mild, moderate or severe. They were counted as having fatigue if they were moderate or severe.

Outcome measures

Measure	Students n=30 Participants All students enrolled at the Mary Cariola Center in Rochester, NY.	Staff n=168 Participants All students enrolled at the Mary Cariola Center in Rochester, NY.
Change in the Percentage of Participants Classified With Fatigue	2.3 percentage of participants	11.8 percentage of participants

PRIMARY outcome

Timeframe: baseline to 16 months

Population: 29 students did not have data collected at 16 months. 165 adults did not have data collected at 16 months.

Social functioning will be measured using the PROMIS-29 assessment. Participants were classified within normal range, mild, moderate or severe. They were counted as having social functioning deficits if they were moderate or severe.

Outcome measures

Measure	Students n=30 Participants All students enrolled at the Mary Cariola Center in Rochester, NY.	Staff n=168 Participants All students enrolled at the Mary Cariola Center in Rochester, NY.
Change in Percentage of Participants With Deficits in Social Functioning	1.7 percentage of participants	1.2 percentage of participants

Adverse Events

Students

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Staff

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Students n=59 participants at risk All students enrolled at the Mary Cariola Center in Rochester, NY. All staff working at the Mary Cariola Center in Rochester, NY.	Staff n=333 participants at risk All students enrolled at the Mary Cariola Center in Rochester, NY. All staff working at the Mary Cariola Center in Rochester, NY.
General disorders faintness	0.00% 0/59 • 16 months	0.30% 1/333 • 16 months
Injury, poisoning and procedural complications Bite	0.00% 0/59 • 16 months	0.30% 1/333 • 16 months
Infections and infestations false positive COVID test	0.00% 0/59 • 16 months	0.90% 3/333 • 16 months

Additional Information

John Foxe, Phd

University of Rochester

Phone: 585 - 275 - 2591

Email: John_foxe@urmc.rochester.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place