COVIDCoVid3SNCT04441710
Caregiver Serological Monitoring Extended Secondarily to Patients With the SARS-CoV-2 Coronavirus
An observational study of COVID, run by Hospices Civils de Lyon at 4 sites in France.
Trial summary
Hospital mortality attributed to SARS-CoV-2 in France increased daily by 28% in the week before confinement. The week following this decision, the daily increase was 30%. During the week of the second week of confinement, it started a decline of 19% estimated over the last 5 days, reaching the cumulative number of… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID
- What is being tested?
- Questionnaire
- How many people
- 2,777 participants
- Where
- 4 sitesFrance
- Study dates
- 27 Oct 2020to 16 Dec 2022
- How long will I take part?
- 18 Months
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Prospective cohort of voluntary caregivers, initially recruited in the CHUs concerned, then among the primary care caregivers, finally among the patients whom these caregivers care for.
Who may be able to join
- Any adult having passed a serological, antigenical or any other type of test in France, and voluntary to participate in the cohort and/or vaccinated against COVID19
- Any child under 18 who has passed a serological, antigenical, or any other type of test in France, willing to participate and at least one of whose parents has accepted to participate in the cohort, and/or vaccinated against COVID19
Who cannot join
- Persons deprived of their liberty
- Adults over whom legal protection applies: guardianship, curatorship
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU de Grenoble - Hôpital Nord
La Tronche
Hôpital de la Croix Rousse
Lyon
CHU de Saint Etienne
Saint-Etienne
Hôpital Henry Gabrielle
Saint-Genis-Laval
About this study
Hospital mortality attributed to SARS-CoV-2 in France increased daily by 28% in the week before confinement. The week following this decision, the daily increase was 30%. During the week of the second week of confinement, it started a decline of 19% estimated over the last 5 days, reaching the cumulative number of 2606 deaths on 29/3 (site https://www.eficiens.com/coronavirus- personal statistics / and calculation).
The diagnosis of viral carriage by RT-PCR is reserved for symptomatic cases among caregivers, due to the shortage of available tests and the cumbersome implementation. The carrier diagnosis is the benchmark, on which are implemented the therapeutic strategies and established the national statistics. It can present false negatives, linked to a research too early or too late in relation to the infection, or to a technical defect of the nasal swab sample. Caregivers on the front line in patient care, in hospitals or in the city, have only partial access to this diagnostic test, depending on the existence of symptoms. The implementation of a systematic serological screening, planned by the government and which cannot be based only on the search for the virus, will make it possible to inform the caregivers presenting symptoms or not, of their serological status, and therefore of their degree immunity or, on the contrary, susceptibility to infectious contacts. It should therefore be very voluntarily requested. On the occasion of this screening, the constitution of the COVID-3S cohort will make it possible to verify the degree of contamination in an asymptomatic population, information which is sorely lacking for the estimation of the immune coverage of the population. The implementation of the Covid-3S study will be based on the work of the National Reference Center of Pr B Lina, from the COVID-SER cohort, for the selection of the most efficient test (s). It seems useful to initiate the constitution of this cohort as soon as possible in relation to the evolution of the epidemic. Pending receipt of official recommendations, the lack of knowledge of the performance of serological tests means that it should be applied first to health professionals, better able to appreciate its limits, for the initial period before determining a validated serological screening strategy. Once the strategy has been specified, the gradual expansion of screening to the patient population will provide a more representative basis for the construction of epidemiological models for evaluating strategies.
- Conditions
- COVID
- Being tested
- Questionnaire
- Keywords
- COVID-19, SARS-COV-2, Serology, Predictability
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Participants will be invited to complete a detailed questionnaire to collect prospectively and retrospectively data around the CoViD19 serological screening.
| Study group | Role | What they receive |
|---|---|---|
| Caregivers | Staff of university hospitals Receives: Other: Questionnaire | |
| Primary care caregivers | Population of professional caregivers such as general practitioner or freelance nurse. Receives: Other: Questionnaire | |
| Patients | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of a reliable prediction model for the effectiveness of virus control
Estimated number of deaths avoided by the various population protection strategies, estimated by applying these strategies to the realistic virtual population.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start27 Oct 2020
- Primary completion16 Dec 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,777 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal FASCIA, MD, Principal investigator, Hospices Civils de LyonFrançois GUEYFFIER, MD, Study director, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441710
- Sponsor's protocol ID
- 69HCL20_0395
- Acronym
- CoVid3S
- Status last verified
- Feb 2023
- First submitted
- 18 Jun 2020
- Last updated
- 3 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Serological Monitoring Extended Secondarily to Patients With the SARS-CoV-2 Coronavirus
- ClinicalTrials.gov ID
- NCT04441710
- Acronym / sponsor ID
- CoVid3S / 69HCL20_0395
- Conditions
- COVID
- Keywords
- COVID-19, SARS-COV-2, Serology, Predictability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,777 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 22 Jun 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.
Hospital mortality attributed to SARS-CoV-2 in France increased daily by 28% in the week before confinement. The week following this decision, the daily increase was 30%. During the week of the second week of confinement, it started a decline of 19% estimated over the last 5 days, reaching the cumulative number of 2606 deaths on 29/3 (site https://www.eficiens.com/coronavirus- personal statistics / and calculation).
The diagnosis of viral carriage by RT-PCR is reserved for symptomatic cases among caregivers, due to the shortage of available tests and the cumbersome implementation. The carrier diagnosis is the benchmark, on which are implemented the therapeutic strategies and established the national statistics. It can present false negatives, linked to a research too early or too late in relation to the infection, or to a technical defect of the nasal swab sample. Caregivers on the front line in patient care, in hospitals or in the city, have only partial access to this diagnostic test, depending on the existence of symptoms. The implementation of a systematic serological screening, planned by the government and which cannot be based only on the search for the virus, will make it possible to inform the caregivers presenting symptoms or not, of their serological status, and therefore of their degree immunity or, on the contrary, susceptibility to infectious contacts. It should therefore be very voluntarily requested. On the occasion of this screening, the constitution of the COVID-3S cohort will make it possible to verify the degree of contamination in an asymptomatic population, information which is sorely lacking for the estimation of the immune coverage of the population. The implementation of the Covid-3S study will be based on the work of the National Reference Center of Pr B Lina, from the COVID-SER cohort, for the selection of the most efficient test (s). It seems useful to initiate the constitution of this cohort as soon as possible in relation to the evolution of the epidemic. Pending receipt of official recommendations, the lack of knowledge of the performance of serological tests means that it should be applied first to health professionals, better able to appreciate its limits, for the initial period before determining a validated serological screening strategy. Once the strategy has been specified, the gradual expansion of screening to the patient population will provide a more representative basis for the construction of epidemiological models for evaluating strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Caregivers | – | Other: QuestionnaireStaff of university hospitals |
| Primary care caregivers | – | Other: QuestionnairePopulation of professional caregivers such as general practitioner or freelance nurse. |
| Patients | – | Other: Questionnaire |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Prospective cohort of voluntary caregivers, initially recruited in the CHUs concerned, then among the primary care caregivers, finally among the patients whom these caregivers care for.
Key inclusion criteria (2 listed)
- Any adult having passed a serological, antigenical or any other type of test in France, and voluntary to participate in the cohort and/or vaccinated against COVID19
- Any child under 18 who has passed a serological, antigenical, or any other type of test in France, willing to participate and at least one of whose parents has accepted to participate in the cohort, and/or vaccinated against COVID19
Key exclusion criteria (2 listed)
- Persons deprived of their liberty
- Adults over whom legal protection applies: guardianship, curatorship
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 |
|---|---|---|
| QuestionnaireParticipants will be invited to complete a detailed questionnaire to collect prospectively and retrospectively data around the CoViD19 serological screening. | Other | Caregivers, Patients, Primary care caregivers |
Primary outcome
Establishment of a reliable prediction model for the effectiveness of virus control
Time frame: 18 months
Estimated number of deaths avoided by the various population protection strategies, estimated by applying these strategies to the realistic virtual population.
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 3 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.
Pascal FASCIA, MD principal investigator
Hospices Civils de Lyon
François GUEYFFIER, MD study director
Hospices Civils de Lyon
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID, run by Hospices Civils de Lyon at 4 sites 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 3 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 4 sites 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?
Establishment of a reliable prediction model for the effectiveness of virus control (time frame: 18 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 3 Feb 2023.