Covid19SPEED-COVIDNCT04872699
Prevalence of COVID-19 in a French Dependent Care Facility for the Elderly and in a French Long-term Care Unit: Observational Study
An observational study of Covid19, run by Centre Hospitalier Sud Essonne at 1 site in France.
Trial summary
The aim of this study is to evaluate the prevalence of COVID-19 among the residents and geriatric inpatients of the care facilities attached to the Centre Hospitalier Sud Essonne (a general hospital located in Ile-de-France, France), and the factors that are likely to influence this prevalence. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Serology testing, RT PCR
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2021to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Residents and geriatric inpatients of the care facilities attached to the Centre Hospitalier Sud Essonne (a general hospital located in Ile-de-France, France), from march, 2020, to december, 2021, who are not opposed to participate in this study.
Who may be able to join
- residents of the dependant care facility for the elderly
- inpatients of the long-term care unit
- from march, 2020 to december, 2021
Who cannot join
- opposition to participate in this study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Sud Essonne
Étampes, Essonne, 91150
Delphine LEMAIRE-BRUNEL, 0033 1 60 80 79 88, dlemaire-brunel@ch-sudessonne.fr
Shidasp SIAMI, MD, PhD
About this study
The aim of this study is to evaluate the prevalence of COVID-19 among the residents and geriatric inpatients of the care facilities attached to the Centre Hospitalier Sud Essonne (a general hospital located in Ile-de-France, France), and the factors that are likely to influence this prevalence.
Read the detailed description
Among people exposed to the COVID-19 (SARS-COV-2) pandemic, elderly people are considered as particularly vulnerable, especially those living in nursing homes or hospitalized. Furthermore, facilities / accommodations are registered among the main locations of COVID-19 clusters.
These observations have led the French government to establish specific protection measures and survey dependent care facilities for the elderly and long-term care units in the hospital.
With these new standards established, a long-term study of all the residents and geriatric inpatients of the care facilities attached to the Centre Hospitalier Sud Essonne (a general hospital located in Ile-de-France, France), can provide additional knowledge on COVID-19.
- Conditions
- Covid19
- Being tested
- Serology testing, RT PCR
- Keywords
- elderly, COVID, SARS-COV-2, prevalence, dependant care, long-term unit
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serology testing, RT PCRDiagnostic test
Periodic testings and testings with characteristic symptoms occur
What is being measured
The primary outcome is the main question the study is designed to answer.
General prevalence of COVID-19
measures the prevalence of COVID-19 among the residents and geriatric inpatients, defined as resident and patients with positive serologic or RT-PCR test
Measured: Through the study completion, an average of 12 months
Secondary outcomes (7)
Number of asymptomatic residents/inpatients
- no RT-PCR test or negative RT-PCR test and positive serologic test,
- positive RT PCR and no symptoms.
Measured: Through study completion, an average of 12 months
Number of symptomatic residents/inpatients
Positive RT-PCR test or serologic test with symptoms
Measured: Through study completion, an average of 12 months
Number of residents/inpatients with severe form of COVID-19 which led to an hospitalization
Positive RT-PCR test or serologic test and hospitalization
Measured: Through study completion, an average of 12 months
Number of residents/inpatients infected with COVID-19 and hospitalized in a critical care unit
Positive RT-PCR test or serologic test and hospitalization in critical care unit
Measured: Through study completion, an average of 12 months
Number of residents/inpatients infected with COVID-19 and deceased
Positive RT-PCR test or serologic test and deceased
Measured: Through study completion, an average of 12 months
Number of residents/inpatients vaccinated against COVID-19
Positive RT-PCR test or serologic test and vaccinated with any authorized vaccine
Measured: Through study completion, an average of 12 months
Influencing factors of the prevalence of COVID-19 among residents/inpatients
- age
- sex
- comorbidities
- the context of the infection with COVID-19
- vaccinated or not
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start22 Apr 2021
- Primary completion31 May 2021 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Essonne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shidasp SIAMI, MD, PhD, Principal investigator, Centre Hospitalier Sud Essonne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872699
- Sponsor's protocol ID
- SPEED-COVID19
- Acronym
- SPEED-COVID
- Status last verified
- May 2021
- First submitted
- 2 May 2021
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of COVID-19 in a French Dependent Care Facility for the Elderly and in a French Long-term Care Unit: Observational Study
- ClinicalTrials.gov ID
- NCT04872699
- Acronym / sponsor ID
- SPEED-COVID / SPEED-COVID19
- Conditions
- Covid19
- Keywords
- elderly, COVID, SARS-COV-2, prevalence, dependant care, long-term unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Sud EssonneUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the prevalence of COVID-19 among the residents and geriatric inpatients of the care facilities attached to the Centre Hospitalier Sud Essonne (a general hospital located in Ile-de-France, France), and the factors that are likely to influence this prevalence.
Detailed description
Among people exposed to the COVID-19 (SARS-COV-2) pandemic, elderly people are considered as particularly vulnerable, especially those living in nursing homes or hospitalized. Furthermore, facilities / accommodations are registered among the main locations of COVID-19 clusters.
These observations have led the French government to establish specific protection measures and survey dependent care facilities for the elderly and long-term care units in the hospital.
With these new standards established, a long-term study of all the residents and geriatric inpatients of the care facilities attached to the Centre Hospitalier Sud Essonne (a general hospital located in Ile-de-France, France), can provide additional knowledge on COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents and geriatric inpatients of the care facilities attached to the Centre Hospitalier Sud Essonne (a general hospital located in Ile-de-France, France), from march, 2020, to december, 2021, who are not opposed to participate in this study.
Key inclusion criteria (3 listed)
- residents of the dependant care facility for the elderly
- inpatients of the long-term care unit
- from march, 2020 to december, 2021
Key exclusion criteria (1 listed)
- opposition to participate in this study
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 |
|---|---|---|
| Serology testing, RT PCRPeriodic testings and testings with characteristic symptoms occur | Diagnostic test | – |
Primary outcome
General prevalence of COVID-19
Time frame: Through the study completion, an average of 12 months
measures the prevalence of COVID-19 among the residents and geriatric inpatients, defined as resident and patients with positive serologic or RT-PCR test
7 secondary outcomes
Number of asymptomatic residents/inpatients
Time frame: Through study completion, an average of 12 months
Number of symptomatic residents/inpatients
Time frame: Through study completion, an average of 12 months
Number of residents/inpatients with severe form of COVID-19 which led to an hospitalization
Time frame: Through study completion, an average of 12 months
Number of residents/inpatients infected with COVID-19 and hospitalized in a critical care unit
Time frame: Through study completion, an average of 12 months
Number of residents/inpatients infected with COVID-19 and deceased
Time frame: Through study completion, an average of 12 months
Number of residents/inpatients vaccinated against COVID-19
Time frame: Through study completion, an average of 12 months
Influencing factors of the prevalence of COVID-19 among residents/inpatients
Time frame: Through study completion, an average of 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
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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.
Shidasp SIAMI, MD, PhD principal investigator
Centre Hospitalier Sud Essonne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Centre Hospitalier Sud Essonne at 1 site in France.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 May 2021. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shidasp SIAMI, MD, PhD (0033 1 60 80 79 40, ssiami@ch-sudessonne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General prevalence of COVID-19 (time frame: Through the study completion, an average of 12 months). 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 4 May 2021.