NCT04887129

Testing for COVID-19 in High Risk Children With Intellectual and Developmental Disabilities (COV-IDD)

Completed NA Results posted Last updated 3 February 2025

What this trial tests

NA trial testing COVID-19 RT-PCR test in Covid19 in 392 participants. Completed in 31 March 2024.

Timeline

3 May 2021

Primary endpoint
31 August 2023

31 March 2024

Quick facts

Lead sponsor	University of Rochester
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	392
Start date	3 May 2021
Primary completion	31 August 2023
Estimated completion	31 March 2024
Sites	1 location across United States

Drugs / interventions tested

• COVID-19 RT-PCR test
• COVID-19 Vaccine Education Campaign

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

University of Rochester

Who can join

Adults 3 to 72, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number Infected With COVID-19 Primary · 16 months

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

Group	Value	95% CI
Students	29
Staff	141

Change in the Percentage of Participants Reporting Anxiety Primary · baseline to 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.

Group	Value	95% CI
Students	11.7
Staff	-0.7

Change in the Percentage of Participants Classified as Depressed Primary · baseline to 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.

Group	Value	95% CI
Students	-0.8
Staff	3.5

Change in the Percentage of Participants Classified With Fatigue Primary · baseline to 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.

Group	Value	95% CI
Students	2.3
Staff	11.8

Change in Percentage of Participants With Deficits in Social Functioning Primary · baseline to 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.

Group	Value	95% CI
Students	1.7
Staff	1.2

Adverse events — posted to ClinicalTrials.gov

Time frame: 16 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Students

Serious: 0/59 (0%)

Deaths: 0/59

Staff

Serious: 0/333 (0%)

Deaths: 0/333

Other adverse events (3 terms — click to expand)

Reaction	System	Students	Staff
false positive COVID test	Infections and infestations	—	—
faintness	General disorders	—	—
Bite	Injury, poisoning and procedural complications	—	—

Data from ClinicalTrials.gov NCT04887129 adverse events section.

Sponsor's own description

The purpose of this study is to understand how to prevent COVID-19 spread in a school like the Mary Cariola Center (MCC) in Rochester, NY by answering questions like these: how do activities in the school alter chances of infection? Are there people infected with the COVID-19 virus who have no symptoms? How is spread of COVID-19 affected by vaccination rates? Is there any hesitancy to get the vaccine and what are the reasons? This information will be used to help keep the school open and the students and staff safe.

Eligible participants are those that work at the Mary Cariola Center (MCC) and interact with the students at MCC who have a high risk of infection from COVID-19.

The study lasts for up to 16 months.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Supporting COVID-19 School Safety for Children With Disabilities and Medical Complexity.
   Sherby MR, Kalb LG, Coller RJ, DeMuri GP, et al · · 2022 · cited 19× · PMID 34737172 · DOI 10.1542/peds.2021-054268h
2. School-Academic Partnerships in Support of Safe Return to Schools During the COVID-19 Pandemic.
   D'Agostino EM, Haroz EE, Linde S, Layer M, et al · · 2022 · cited 8× · PMID 34737180 · DOI 10.1542/peds.2021-054268c