CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 392 enrolled
Drug / intervention
COVID-19 RT-PCR test +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04887129
NCT04887129N/ACompleted
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COV-IDD: Testing for COVID-19 in High Risk Children With Intellectual and Developmental Disabilities

University of Rochester·interventional·Posted May 14, 2021·Updated Feb 3, 2025

In Brief

A clinical study evaluating COVID-19 RT-PCR test and COVID-19 Vaccine Education Campaign for Covid19. Completed, enrolled 392 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMay 14, 2021
Enrollment StartMay 3, 2021
Primary CompletionAug 31, 2023
Study CompletionMar 31, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.1 years ago

Interventions

COVID-19 RT-PCR testother

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 Campaignother

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