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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04887129
• Other study ID #: STUDY00005294
• Secondary ID: OT2HD107553-01
• Status: Completed
• Phase: N/A
• Start date: May 3, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: October 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: March 31, 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 72 Years

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Developmental Disabilities

Intervention

Diagnostic Test:
• COVID-19 RT-PCR test
Participating individuals (students and employees) will be tested for COVID-19 (RT-PCR) using a specimen collected using a mid-turbinate swab. This asymptomatic testing regime starts on or after (if scheduling testing requires this to begin on a different day) enrollment and is repeated every 5-14 days for up to 16 months . Anyone testing positive is followed up as described below for symptomatic individuals. Those presenting with symptoms will be also tested for COVID-19 (RT-PCR). Those with negative test results will return to the asymptomatic testing protocol. Students who test positive are retested then 3 days until two negative tests. Employees who test positive also be tested every 3 days until two negative tests.

Other:
• COVID-19 Vaccine Education Campaign
Utilizing information from focus groups, the investigators will develop and deploy an educational campaign aimed at improving vaccine hesitancy and student health

Locations

Country	Name	City	State
United States	Mary Cariola Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of students infected with COVID-19	Number of students who test positive for COVID-19 at least once using a nasal swab test.	16 months
Primary	Number of staff infected with COVID-19	Number of staff who test positive for COVID-19 at least once using a nasal swab test.	16 months
Primary	Mean change in anxiety in students	Anxiety will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher anxiety.	baseline to 16 months
Primary	Mean change in anxiety in staff	Anxiety will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher anxiety.	baseline to 16 months
Primary	Mean change in depression in students	Depression will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher depression.	baseline to 16 months
Primary	Mean change in depression in staff	Depression will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher depression.	baseline to 16 months
Primary	Mean change in fatigue in students	Fatigue will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher fatigue.	baseline to 16 months
Primary	Mean change in fatigue in staff	Fatigue will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher fatigue.	baseline to 16 months
Primary	Mean change in social functioning in students	Social functioning will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher social disfunction.	baseline to 16 months
Primary	Mean change in social functioning in staff	Social functioning will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher social disfunction.	baseline to 16 months