COVID-19CERONCT05270980
COVID-19 Serologic Strategies for Skilled Nursing Facilities
A study testing Cohorting in people with COVID-19, run by NYU Langone Health at 2 sites in United States.
Trial summary
The COVID-19 pandemic ravaged United States skilled-nursing facilities (SNFs). Novel strategies that maximize the safety and quality of life for SNF residents with ADRD and staff who care for them are urgently needed. Thus, the study's objectives are: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Cohorting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Aug 2021to 4 Feb 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be employees of ArchCare
- Must be members of included unit staff or those that float on those designated units
- Willing to participate in focus groups or semi-structured interviews with study team
- Family members of residents who reside at either TCC or MMW (ArchCare facilities)
- Family member of resident who is on designated study unit or eligible to be transferred to such unit
- Willing to participate in focus groups or semi-structured interviews with study team
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- Resident has ability to communicate and follow simple commands
- Resident has ability to communicate and follow simple commands
- English- or Spanish-speaking
- Resident has capacity to consent assessed with standard questions used to assess capacity or having a surrogate who can provide consent.
- Must agree to have serologic testing for COVID-19
- Agrees to remain on one of the facility units of study or to be transferred to such unit
Who cannot join
- Not employees of ArchCare
- Not members of included unit staff or those that float on those designated units
- Not willing to participate in focus groups or semi-structured interviews with study team
- Not family members of residents who reside at either TCC or MMW (ArchCare facilities)
- Not family member of resident who is on designated study unit or eligible to be transferred to such unit
- Not willing to participate in focus groups or semi-structured interviews with study team
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- Resident is not living in the unit of intervention
- Resident does not have ability to communicate and follow simple commands
- Not English- or Spanish-speaking
- Resident lacks capacity to consent assessed with standard questions used to assess capacity and does not have a surrogate who can provide consent.
- If resident lacks capacity, that resident does not assent with surrogate who provides assent
- Does not agree to have serologic testing for COVID-19
- Refuses to agree to remain on one of the facility units of study or to be transferred to such unit
Trial locations and contacts
2 sites in 1 country.
United States2 sites
ArchCare at Mary Manning Walsh Home (MMW)
New York, New York, 10021
ArchCare at Terence Cardinal Cooke Health Care Center (TCC)
New York, New York, 10029
About this study
Official title: COVID-19 Serologic Strategies for Skilled Nursing Facilities (CERO)
The COVID-19 pandemic ravaged United States skilled-nursing facilities (SNFs). Novel strategies that maximize the safety and quality of life for SNF residents with ADRD and staff who care for them are urgently needed. Thus, the study's objectives are:
- To rapidly plan and pilot test an intervention that leverages COVID-19 antibody and PCR status to pair SNF staff with residents in the safest way possible
- To reduce reduced COVID-19 incidence rate compared to SNFs not using this novel staff-resident assignment strategy.
- Conditions
- COVID-19
- Being tested
- Cohorting
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CohortingOther
The cohorting strategy will result in "pairing" serology-positive staff with serology-negative residents and serology-negative staff and serology-positive residents to the degree that penetration of serologic presumed immunity allows this pairing to be positive. Any resident who refuses serology testing will be treated as if they are serology negative as the safest strategy for risk of unwanted exposure.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Cohorting) | Experimental | Not described Receives: Other: Cohorting |
| Control Group (No Cohorting) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of New COVID-19 Detected Infections Among Residents
Measured: Up to Month 5
Secondary outcomes (2)
Number of New COVID-19 Detected Infections Among Staff
Measured: Up to Month 5
Number of Hospitalizations Over Time
Measured: Up to Month 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start11 Aug 2021
- Primary completion4 Feb 2022
- Study completion4 Feb 2022
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 COVID-19Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Joshua Chodosh, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270980
- Sponsor's protocol ID
- 20-01281
- Other IDs
- 3U54AG063546-02S4
- Acronym
- CERO
- Status last verified
- Mar 2023
- First submitted
- 7 Mar 2022
- Last updated
- 6 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Serologic Strategies for Skilled Nursing Facilities (CERO)
- ClinicalTrials.gov ID
- NCT05270980
- Acronym / sponsor ID
- CERO / 20-01281
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Brown University, National Institute on Aging (NIA)
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 8 Mar 2022 (actual)
- Results
- Posted 6 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The COVID-19 pandemic ravaged United States skilled-nursing facilities (SNFs). Novel strategies that maximize the safety and quality of life for SNF residents with ADRD and staff who care for them are urgently needed. Thus, the study's objectives are:
- To rapidly plan and pilot test an intervention that leverages COVID-19 antibody and PCR status to pair SNF staff with residents in the safest way possible
- To reduce reduced COVID-19 incidence rate compared to SNFs not using this novel staff-resident assignment strategy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Cohorting) | Experimental | Other: Cohorting |
| Control Group (No Cohorting) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Must be employees of ArchCare
- Must be members of included unit staff or those that float on those designated units
- Willing to participate in focus groups or semi-structured interviews with study team
- Family members of residents who reside at either TCC or MMW (ArchCare facilities)
- Family member of resident who is on designated study unit or eligible to be transferred to such unit
Key exclusion criteria (13 listed)
- Not employees of ArchCare
- Not members of included unit staff or those that float on those designated units
- Not willing to participate in focus groups or semi-structured interviews with study team
- Not family members of residents who reside at either TCC or MMW (ArchCare facilities)
- Not family member of resident who is on designated study unit or eligible to be transferred to such unit
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 |
|---|---|---|
| CohortingThe cohorting strategy will result in "pairing" serology-positive staff with serology-negative residents and serology-negative staff and serology-positive residents to the degree that penetration of serologic presumed immunity allows this pairing to be positive. Any resident who refuses serology testing will be treated as if they are serology negative as the safest strategy for risk of unwanted exposure. | Other | Intervention Group (Cohorting) |
Primary outcome
Number of New COVID-19 Detected Infections Among Residents
Time frame: Up to Month 5
2 secondary outcomes
Number of New COVID-19 Detected Infections Among Staff
Time frame: Up to Month 5
Number of Hospitalizations Over Time
Time frame: Up to Month 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
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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.
Joshua Chodosh, MD principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cohorting in people with COVID-19, run by NYU Langone Health at 2 sites 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 12 inclusion and 13 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 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 6 Apr 2023). 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 of New COVID-19 Detected Infections Among Residents (time frame: Up to Month 5). 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 6 Apr 2023.