N/A
Completed N=392
Testing for COVID-19 in High Risk Children With Intellectual and Developmental Disabilities (COV-IDD)
Source: ClinicalTrials.gov NCT04887129 ↗Enrolled (actual)
392
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Number Infected With COVID-19 — 29; 141 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number Infected With COVID-19 |
29; 141 | — |
| PRIMARY Change in the Percentage of Participants Reporting Anxiety |
11.7; -0.7 | — |
| PRIMARY Change in the Percentage of Participants Classified as Depressed |
-0.8; 3.5 | — |
| PRIMARY Change in the Percentage of Participants Classified With Fatigue |
2.3; 11.8 | — |
| PRIMARY Change in Percentage of Participants With Deficits in Social Functioning |
1.7; 1.2 | — |
Eligibility Criteria
Inclusion Criteria
Students:
- IDD Student of the Mary Cariola Center
- Age 3 - 18
- Have a parent/guardian who can give informed consent
- In the judgement of the Mary Cariola Medical Staff will be able to safely participate in the study procedures (nasal swab, phlebotomy)
Staff
- Age 18 - 72
- Able give informed consent
- Anticipated duration of remaining employment less than 1 month (e.g. retiring)
- Must be willing to participate in RT-PCR and antibody testing
Exclusion Criteria
Students
- Contraindication to nasal swab
- Contraindication to phlebotomy (e.g. anticoagulated, bleeding diathesis)
Staff
- Contraindication to nasal swab
- Contraindication to phlebotomy (e.g. anticoagulated, bleeding diathesis)
Data sourced from ClinicalTrials.gov (NCT04887129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.