Symptoms Related to Covid-19COVID - EHPADNCT04677283
Study of Symptoms Linked to Covid-19 in Residents and Professionals in EHPAD, Associated With a Dual Diagnostic Approach by PCR and Serology: a Cohort in Île-de-France.
An observational study of Symptoms Related to Covid-19, run by Gérond'if at 1 site in France.
Trial summary
The main purpose is to study the prevalence of Covid-19 in EHPAD. The primary endpoint will be the combination of PCR results and symptomatology, making it possible to define positive cases in EHPAD, in residents and professionals in contact with them. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Symptoms Related to Covid-19
- How many people
- 1,059 participants
- Where
- 1 siteFrance
- Study dates
- 7 May 2020to 8 Jul 2021
- 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: Two types of population, EHPAD residents identified and EHPAD professionals
Who may be able to join
- / Residents of nursing homes in Île-de-France in which systematic Covid-19 screening tests were carried out and agreeing to participate in the study.
- / Professionals in nursing homes in Île-de-France in which systematic screening tests for Covid-19 were carried out and agreeing to participate in the study: nursing assistants, nurses, coordinating doctors, hotel and service agents hygiene, etc.
Who cannot join
- / Expression of opposition to the collection of symptoms by professionals, residents or their legal representatives.
- / Subjects who have not had a diagnostic test by RT-PCR.
Trial locations and contacts
1 site in 1 country.
France1 site
Autonomy Department; ARS Île-de-France
Paris, ARS Île-de-France, 75019
About this study
The main purpose is to study the prevalence of Covid-19 in EHPAD. The primary endpoint will be the combination of PCR results and symptomatology, making it possible to define positive cases in EHPAD, in residents and professionals in contact with them. The prevalence obtained can be compared with the results of serology if these are performed.
Read the detailed description
This study is taking place in several nursing homes in Ile-de-France, which will be recruited at the end of the diagnostic campaign.
At the initiative of the ARS Ile-de-France, residents and professionals of selected EHPADs will be subjected to systematic screening by RT-PCR for Covid-19, then by serology after the first screening, regardless of whether either the result
Samples, by nasopharyngeal swab for RT-PCR, by capillary blood sampling or venipuncture according to the technique for serology, will be carried out according to the doctrines issued by the ARS Ile de France and the variations proposed by the appropriate departmental directorates in depending on local resources. The results will be brought to the attention of EHPADs to adapt the care of residents and positive professionals.
Data will be collected daily from collection for the first test (RT-PCR), or retrospectively if the collection took place before the study.
Regarding the approach for collecting serologies:
- All subjects included with a negative PCR will be offered the serological test, in accordance with the recommendations in force or the medical decisions of the establishments.
- The qualitative results of the serologies of the subjects included in the study (residents and professionals) will be collected according to the same circuit as those of the RT-PCRs.
- Only the symptoms of residents with a positive serology will be collected, from the date of the sample and for a period of 14 days.
- The symptoms of professionals with a positive serology can be collected, from the date of the sample and for a period of 14 days without mandatory character.
- Both techniques (ELISA or TROD) are accepted and the serology values will not be collected.
- Conditions
- Symptoms Related to Covid-19
- Keywords
- Covid-19, serology, Reverse Transcriptase PCR
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
To define positive cases of coronavirus by "Polymerase Chain Reaction" results and symptomatologies
Measured: 3 Months
Secondary outcomes (5)
Assessment of commorbidity risk according Charlson score
Measured: 3 Months
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
Measured: 3 Months
Assessment of teh degree of autonomy according AGGIR score
Measured: 3 Months
Measuring cognitive impairment according Mini-Mental State Examination (MMSE) scores
Measured: 3 Months
Screening for a nutritional disorder according Body Mass Index (BMI) score
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start7 May 2020
- Primary completion9 Dec 2020
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptoms Related to Covid-19Studies 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
- Retrospective
- Enrolment
- 1,059 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martine LE NOC - SOUDANI, MD, Study chair, Autonomy Department; ARS Île-de-France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677283
- Sponsor's protocol ID
- 2020-A01027-32
- Acronym
- COVID - EHPAD
- Status last verified
- Feb 2023
- First submitted
- 18 Dec 2020
- Last updated
- 14 Feb 2023
- 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 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Symptoms Linked to Covid-19 in Residents and Professionals in EHPAD, Associated With a Dual Diagnostic Approach by PCR and Serology: a Cohort in Île-de-France.
- ClinicalTrials.gov ID
- NCT04677283
- Acronym / sponsor ID
- COVID - EHPAD / 2020-A01027-32
- Conditions
- Symptoms Related to Covid-19
- Keywords
- Covid-19, serology, Reverse Transcriptase PCR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,059 participants (actual)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 7 May 2020 (actual)
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 21 Dec 2020 (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 main purpose is to study the prevalence of Covid-19 in EHPAD. The primary endpoint will be the combination of PCR results and symptomatology, making it possible to define positive cases in EHPAD, in residents and professionals in contact with them. The prevalence obtained can be compared with the results of serology if these are performed.
Detailed description
This study is taking place in several nursing homes in Ile-de-France, which will be recruited at the end of the diagnostic campaign.
At the initiative of the ARS Ile-de-France, residents and professionals of selected EHPADs will be subjected to systematic screening by RT-PCR for Covid-19, then by serology after the first screening, regardless of whether either the result
Samples, by nasopharyngeal swab for RT-PCR, by capillary blood sampling or venipuncture according to the technique for serology, will be carried out according to the doctrines issued by the ARS Ile de France and the variations proposed by the appropriate departmental directorates in depending on local resources. The results will be brought to the attention of EHPADs to adapt the care of residents and positive professionals.
Data will be collected daily from collection for the first test (RT-PCR), or retrospectively if the collection took place before the study.
Regarding the approach for collecting serologies:
- All subjects included with a negative PCR will be offered the serological test, in accordance with the recommendations in force or the medical decisions of the establishments.
- The qualitative results of the serologies of the subjects included in the study (residents and professionals) will be collected according to the same circuit as those of the RT-PCRs.
- Only the symptoms of residents with a positive serology will be collected, from the date of the sample and for a period of 14 days.
- The symptoms of professionals with a positive serology can be collected, from the date of the sample and for a period of 14 days without mandatory character.
- Both techniques (ELISA or TROD) are accepted and the serology values will not be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two types of population, EHPAD residents identified and EHPAD professionals
Key inclusion criteria (2 listed)
- / Residents of nursing homes in Île-de-France in which systematic Covid-19 screening tests were carried out and agreeing to participate in the study.
- / Professionals in nursing homes in Île-de-France in which systematic screening tests for Covid-19 were carried out and agreeing to participate in the study: nursing assistants, nurses, coordinating doctors, hotel and service agents hygiene, etc.
Key exclusion criteria (2 listed)
- / Expression of opposition to the collection of symptoms by professionals, residents or their legal representatives.
- / Subjects who have not had a diagnostic test by RT-PCR.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To define positive cases of coronavirus by "Polymerase Chain Reaction" results and symptomatologies
Time frame: 3 Months
5 secondary outcomes
Assessment of commorbidity risk according Charlson score
Time frame: 3 Months
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
Time frame: 3 Months
Assessment of teh degree of autonomy according AGGIR score
Time frame: 3 Months
Measuring cognitive impairment according Mini-Mental State Examination (MMSE) scores
Time frame: 3 Months
Screening for a nutritional disorder according Body Mass Index (BMI) score
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
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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.
Martine LE NOC - SOUDANI, MD study chair
Autonomy Department; ARS Île-de-France
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 Symptoms Related to Covid-19, run by Gérond'if 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 2 inclusion and 2 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 14 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To define positive cases of coronavirus by "Polymerase Chain Reaction" results and symptomatologies (time frame: 3 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 14 Feb 2023.