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Completed

NCT Number: NCT04887129

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

3 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mary Cariola Center

Rochester, New York, 14620, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

COVID-19 RT-PCR test

Diagnostic 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.

COVID-19 Vaccine Education Campaign

Other

Utilizing information from focus groups, the investigators will develop and deploy an educational campaign aimed at improving vaccine hesitancy and student health

Primary outcomes

  1. Number Infected With COVID-19

    Time frame: 16 months

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

  2. Change in the Percentage of Participants Reporting Anxiety

    Time frame: 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.

  3. Change in the Percentage of Participants Classified as Depressed

    Time frame: 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.

  4. Change in the Percentage of Participants Classified With Fatigue

    Time frame: 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.

  5. Change in Percentage of Participants With Deficits in Social Functioning

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
May 14, 2021
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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