Covid19NCT04887129
Testing for COVID-19 in High Risk Children With Intellectual and Developmental Disabilities (COV-IDD)
A study testing COVID-19 RT-PCR test and COVID-19 Vaccine Education Campaign in people with Covid19, run by University of Rochester at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 3 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- COVID-19 RT-PCR test and COVID-19 Vaccine Education Campaign
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2021to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 72 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COV-IDD: Testing for COVID-19 in High Risk Children With Intellectual and Developmental Disabilities
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.
- Conditions
- Covid19
- Being tested
- COVID-19 RT-PCR test, COVID-19 Vaccine Education Campaign
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 RT-PCR testDiagnostic 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 CampaignOther
Utilizing information from focus groups, the investigators will develop and deploy an educational campaign aimed at improving vaccine hesitancy and student health
| Study group | Role | What they receive |
|---|---|---|
| Students and staff at Mary Cariola Center | Experimental | All students enrolled at the Mary Cariola Center in Rochester, NY. All staff working at the Mary Cariola Center in Rochester, NY. Receives: Diagnostic Test: COVID-19 RT-PCR test; Other: COVID-19 Vaccine Education Campaign |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Infected With COVID-19
Number of students or staff who test positive for COVID-19 at least once using a nasal swab test.
Measured: 16 months
Change in the Percentage of Participants Reporting Anxiety
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.
Measured: baseline to 16 months
Change in the Percentage of Participants Classified as Depressed
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.
Measured: baseline to 16 months
Change in the Percentage of Participants Classified With Fatigue
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.
Measured: baseline to 16 months
Change in Percentage of Participants With Deficits in Social Functioning
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.
Measured: baseline to 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start3 May 2021
- Primary completion31 Aug 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, John Foxe, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887129
- Sponsor's protocol ID
- STUDY00005294
- Other IDs
- OT2HD107553-01
- Status last verified
- Jan 2025
- First submitted
- 13 May 2021
- Last updated
- 3 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COV-IDD: Testing for COVID-19 in High Risk Children With Intellectual and Developmental Disabilities
- ClinicalTrials.gov ID
- NCT04887129
- Acronym / sponsor ID
- STUDY00005294
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 3 May 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 14 May 2021 (actual)
- Results
- Posted 3 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Students and staff at Mary Cariola Center | Experimental | Diagnostic Test: COVID-19 RT-PCR test, Other: COVID-19 Vaccine Education CampaignAll students enrolled at the Mary Cariola Center in Rochester, NY. All staff working at the Mary Cariola Center in Rochester, NY. |
Who may qualify
- Ages
- 3 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- Students
- Contraindication to nasal swab
- Contraindication to phlebotomy (e.g. anticoagulated, bleeding diathesis)
- Staff
- Contraindication to nasal swab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 RT-PCR testParticipating 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. | Diagnostic test | Students and staff at Mary Cariola Center |
| COVID-19 Vaccine Education CampaignUtilizing information from focus groups, the investigators will develop and deploy an educational campaign aimed at improving vaccine hesitancy and student health | Other | Students and staff at Mary Cariola Center |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID-19 RT-PCR test and COVID-19 Vaccine Education Campaign in people with Covid19, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number Infected With COVID-19 (time frame: 16 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.