COVID-19INMESO-CovidNCT05085522
Study of the Effect of Systematic Screening of Residents and Caregivers With Covid-19 by Nasopharyngeal Swab (RT-PCR)
An observational study of COVID-19, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The current COVID-19 epidemic has overwhelmed the health systems of many countries in which it has broken out, forcing various governments to institute population containment measures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2020to 30 Jan 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
- Adult, Older adult
Study population: Major subject (≥18 years old) hospitalized in a medico-social institution for the elderly (SMTI or EHPAD) at the HUS or in another center which will be recruited secondarily and whose patients in a unit all have the same attending physician.
Who may be able to join
- Major subject (≥18 years old)
- Subject hospitalized in a medico-social institution for the elderly (SMTI or EHPAD) at the HUS or in another center which will be recruited secondarily and whose patients in a unit all have the same attending physician.
- Subject (or family) who did not express their disagreement with the reuse of this data for the purposes of this research.
Who cannot join
- Subject having expressed opposition to participating in the study
- Subject under guardianship or guardianship
- Subject under safeguard of justice
Trial locations and contacts
1 site in 1 country.
Saïd CHAYER, PhD, HDR contact
France1 site, 1 recruiting
- Recruiting
Service Gériatrie. Soins Médico-techniques Importants - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Alexandre BOUSSUGE, MD, 33 3 88 11 54 61, alexandre.boussuge@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, said.chayer@chru-strasbourg.fr
About this study
Official title: Study of the Effect of Systematic Screening of Residents and Caregivers by Nasopharyngeal Swab (RT-PCR) on the Incidence Rate of COVID-19 Infection in Medico-social Institutions for the Elderly
The current COVID-19 epidemic has overwhelmed the health systems of many countries in which it has broken out, forcing various governments to institute population containment measures.
Residents of medico-social institutions for the elderly are particularly at risk of developing severe forms because they have a large number of factors favoring the progression to a severe form (very advanced age, multiple comorbidities, dependence in activities of dayli life).
Read more
The specificity and positive predictive value of clinical signs are not very important in this population; which makes the diagnosis even more complicated.
One of the strategies to try to protect these residents, in addition to room containment and clinical surveillance, would be to carry out a systematic screening campaign of all residents and all caregivers, then to consider reorganizing the establishments with a sector "COVID +".
This was announced by the French Minister of Health Olivier VERAN on 04/06/2020 from the first confirmed case of COVID-19 in an institution.
However, asymptomatic subjects may have a "negative" RT-PCR test at one point but which is positive in the following days. And in this interval they would still be contagious.
It is therefore not excluded that the implementation of such a screening campaign will not be effective in reducing the number of new cases of COVID-19 in medico-social institutions for the elderly
- Conditions
- COVID-19
- Keywords
- COVID-19, RT-PCR, SARS-CoV-2
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of the effect of systematic screening of residents and caregivers by nasopharyngeal swab (RT-PCR) on the incidence rate of COVID-19 infection
Measured: Files analysed retrospectively from March 15, 2020 to July 31, 2020 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start1 Aug 2020
- Primary completion30 Jan 2022 (estimated)
- Study completion30 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre BOUSSUGE, MD, Principal investigator, Service Gériatrie. Soins Médico-techniques Importants - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085522
- Sponsor's protocol ID
- 7953
- Acronym
- INMESO-Covid
- Status last verified
- Oct 2021
- First submitted
- 7 Oct 2021
- Last updated
- 1 Dec 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 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Systematic Screening of Residents and Caregivers by Nasopharyngeal Swab (RT-PCR) on the Incidence Rate of COVID-19 Infection in Medico-social Institutions for the Elderly
- ClinicalTrials.gov ID
- NCT05085522
- Acronym / sponsor ID
- INMESO-Covid / 7953
- Conditions
- COVID-19
- Keywords
- COVID-19, RT-PCR, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 30 Jan 2022 (estimated)
- First posted
- 20 Oct 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 current COVID-19 epidemic has overwhelmed the health systems of many countries in which it has broken out, forcing various governments to institute population containment measures.
Residents of medico-social institutions for the elderly are particularly at risk of developing severe forms because they have a large number of factors favoring the progression to a severe form (very advanced age, multiple comorbidities, dependence in activities of dayli life).
The specificity and positive predictive value of clinical signs are not very important in this population; which makes the diagnosis even more complicated.
One of the strategies to try to protect these residents, in addition to room containment and clinical surveillance, would be to carry out a systematic screening campaign of all residents and all caregivers, then to consider reorganizing the establishments with a sector "COVID +".
This was announced by the French Minister of Health Olivier VERAN on 04/06/2020 from the first confirmed case of COVID-19 in an institution.
However, asymptomatic subjects may have a "negative" RT-PCR test at one point but which is positive in the following days. And in this interval they would still be contagious.
It is therefore not excluded that the implementation of such a screening campaign will not be effective in reducing the number of new cases of COVID-19 in medico-social institutions for the elderly
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major subject (≥18 years old) hospitalized in a medico-social institution for the elderly (SMTI or EHPAD) at the HUS or in another center which will be recruited secondarily and whose patients in a unit all have the same attending physician.
Key inclusion criteria (3 listed)
- Major subject (≥18 years old)
- Subject hospitalized in a medico-social institution for the elderly (SMTI or EHPAD) at the HUS or in another center which will be recruited secondarily and whose patients in a unit all have the same attending physician.
- Subject (or family) who did not express their disagreement with the reuse of this data for the purposes of this research.
Key exclusion criteria (3 listed)
- Subject having expressed opposition to participating in the study
- Subject under guardianship or guardianship
- Subject under safeguard of justice
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
Retrospective study of the effect of systematic screening of residents and caregivers by nasopharyngeal swab (RT-PCR) on the incidence rate of COVID-19 infection
Time frame: Files analysed retrospectively from March 15, 2020 to July 31, 2020 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 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.
Saïd CHAYER, PhD, HDR contact
Alexandre BOUSSUGE, MD principal investigator
Service Gériatrie. Soins Médico-techniques Importants - Hôpitaux Universitaires de Strasbourg
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 COVID-19, run by University Hospital, Strasbourg, France 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 3 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 1 Dec 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 Alexandre BOUSSUGE, MD (33 3 88 11 54 61, alexandre.boussuge@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective study of the effect of systematic screening of residents and caregivers by nasopharyngeal swab (RT-PCR) on the incidence rate of COVID-19 infection (time frame: Files analysed retrospectively from March 15, 2020 to July 31, 2020 will be examined]). 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 1 Dec 2021.