COVID-19ED-Covid-19NCT06200610
Study of Prevalence of the Covid-19 Among the Staff of the Emergency Department
An observational study of COVID-19, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Since December 2019, a new coronavirus, SARS-CoV-2, has been identified in the city of Wuhan in Hubei province in China and is the cause of a global pandemic. This highly contagious virus is responsible for the COVID-19 disease, the manifestations of which can range from a simple flu-like syndrome to acute respiratory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2021to Jan 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult (≥18 years old) part of the emergency staff of the HUS or Besançon University Hospital having worked during the period of the covid-19 pandemic, from March 1, 2020 to May 31, 2020, and Having carried out serology within the framework of the recommendations of the High Authority of Health of May 2, 2020 on the screening of caregivers
Who may be able to join
- Adult (≥18 years old)
- Part of the emergency staff of the HUS or Besançon University Hospital having worked during the period of the covid-19 pandemic, from March 1, 2020 to May 31, 2020.
- Having carried out serology within the framework of the recommendations of the High Authority of Health of May 2, 2020 on the screening of caregivers
- Having given consent for its biological resources to be reused for research purposes
Who cannot join
- Subject having expressed opposition to participating in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Accueil des Urgences - CHU de Strasbourg - France
Strasbourg, 67091
Sabrina Garnier Kepka, MD, 33 3 69 55 13 35, Sabrina.GARNIER-KEPKA@chru-strasbourg.fr
Sabrina Garnier Kepka, MD
About this study
Since December 2019, a new coronavirus, SARS-CoV-2, has been identified in the city of Wuhan in Hubei province in China and is the cause of a global pandemic. This highly contagious virus is responsible for the COVID-19 disease, the manifestations of which can range from a simple flu-like syndrome to acute respiratory distress syndrome (ARDS). Transmission of SARS-CoV-2 is mainly linked to droplets. The mode of transmission of SARS-CoV-2 involves at least droplet-type isolation for caregivers with wearing a surgical mask and extended contact type (overcoats, caps, gloves). During procedures with a high risk of aerosolization of viral particles (intubation, aerosols, aspirations, nasopharyngeal swabs), wearing an FFP2 mask and protective glasses are recommended. In addition, oxygen therapy, particularly at a flow rate greater than 6 L/min, could also lead to airborne contamination.
The occupational risk of contamination of health professionals is well identified, particularly in Chinese but also Italian studies. In Italy, 20% of healthcare workers have been contaminated. In China, a rate of 3.5 to 29% in Wuhan hospitals has been identified.
Read more
Among the professionals exposed within the hospital, those in emergency services are part of the category with the greatest risk of contamination along with those in intensive care units. Recommendations from experts from the French intensive care society and foreign companies made it possible to identify the situations most at risk of contamination. In addition, the organization has made it possible to better understand patient care circuits in order to limit the risks of contamination. However, procedural errors may exist, implying the need for frequent training sessions for professionals. In addition, if the recommendations specify the need to obtain negative pressure in the rooms or at least zero, the material limits linked to reception in emergency departments with the need for intubation of a significant number of patients sometimes makes it difficult to carry out these risky actions under optimal conditions. Finally, the methods of sorting suspected cases to organize care in areas different from other emergency patients do not prevent assignment errors, a source of contamination for caregivers and patients.
Thus, health professionals are among the priority people to be screened in accordance with the recommendations of the High Authority of Health. Indeed, even if symptomatic healthcare workers were mostly screened at least by taking a nasopharyngeal swab, some healthcare workers were able to develop immunity to the disease without having been symptomatic. The number of asymptomatic cases of COVID-19 is significant, but the proportion is not yet clearly identified. In addition, massive screening of symptomatic and non-symptomatic healthcare workers would make it possible to reduce the number of nososcomial contamination. Determining the serological status of healthcare workers is a priority, particularly in services on the front line of caring for patients with COVID-19, such as emergency structures.
Read the detailed description
The aim of the study is to study the seroprevalence of SARS-CoV2 among healthcare personnel in the emergency services of the Strasbourg University Hospitals and the Besançon University Hospital.
- Conditions
- COVID-19
- Keywords
- Covid-19, COVID-19 Pandemic, Emergency services
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of antibodies specific to SARS-CoV2 in the serum in the subjects studied
Measured: Through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start10 Jan 2021
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (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-control
- Time perspective
- Retrospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200610
- Sponsor's protocol ID
- 8018
- Acronym
- ED-Covid-19
- Status last verified
- Dec 2023
- First submitted
- 22 Dec 2023
- Last updated
- 11 Jan 2024
- 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 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Prevalence of the Covid-19 Among the Staff of the Emergency Department
- ClinicalTrials.gov ID
- NCT06200610
- Acronym / sponsor ID
- ED-Covid-19 / 8018
- Conditions
- COVID-19
- Keywords
- Covid-19, COVID-19 Pandemic, Emergency services
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 11 Jan 2024 (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.
Since December 2019, a new coronavirus, SARS-CoV-2, has been identified in the city of Wuhan in Hubei province in China and is the cause of a global pandemic. This highly contagious virus is responsible for the COVID-19 disease, the manifestations of which can range from a simple flu-like syndrome to acute respiratory distress syndrome (ARDS). Transmission of SARS-CoV-2 is mainly linked to droplets. The mode of transmission of SARS-CoV-2 involves at least droplet-type isolation for caregivers with wearing a surgical mask and extended contact type (overcoats, caps, gloves). During procedures with a high risk of aerosolization of viral particles (intubation, aerosols, aspirations, nasopharyngeal swabs), wearing an FFP2 mask and protective glasses are recommended. In addition, oxygen therapy, particularly at a flow rate greater than 6 L/min, could also lead to airborne contamination.
The occupational risk of contamination of health professionals is well identified, particularly in Chinese but also Italian studies. In Italy, 20% of healthcare workers have been contaminated. In China, a rate of 3.5 to 29% in Wuhan hospitals has been identified.
Among the professionals exposed within the hospital, those in emergency services are part of the category with the greatest risk of contamination along with those in intensive care units. Recommendations from experts from the French intensive care society and foreign companies made it possible to identify the situations most at risk of contamination. In addition, the organization has made it possible to better understand patient care circuits in order to limit the risks of contamination. However, procedural errors may exist, implying the need for frequent training sessions for professionals. In addition, if the recommendations specify the need to obtain negative pressure in the rooms or at least zero, the material limits linked to reception in emergency departments with the need for intubation of a significant number of patients sometimes makes it difficult to carry out these risky actions under optimal conditions. Finally, the methods of sorting suspected cases to organize care in areas different from other emergency patients do not prevent assignment errors, a source of contamination for caregivers and patients.
Thus, health professionals are among the priority people to be screened in accordance with the recommendations of the High Authority of Health. Indeed, even if symptomatic healthcare workers were mostly screened at least by taking a nasopharyngeal swab, some healthcare workers were able to develop immunity to the disease without having been symptomatic. The number of asymptomatic cases of COVID-19 is significant, but the proportion is not yet clearly identified. In addition, massive screening of symptomatic and non-symptomatic healthcare workers would make it possible to reduce the number of nososcomial contamination. Determining the serological status of healthcare workers is a priority, particularly in services on the front line of caring for patients with COVID-19, such as emergency structures.
Detailed description
The aim of the study is to study the seroprevalence of SARS-CoV2 among healthcare personnel in the emergency services of the Strasbourg University Hospitals and the Besançon University Hospital.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (≥18 years old) part of the emergency staff of the HUS or Besançon University Hospital having worked during the period of the covid-19 pandemic, from March 1, 2020 to May 31, 2020, and Having carried out serology within the framework of the recommendations of the High Authority of Health of May 2, 2020 on the screening of caregivers
Key inclusion criteria (4 listed)
- Adult (≥18 years old)
- Part of the emergency staff of the HUS or Besançon University Hospital having worked during the period of the covid-19 pandemic, from March 1, 2020 to May 31, 2020.
- Having carried out serology within the framework of the recommendations of the High Authority of Health of May 2, 2020 on the screening of caregivers
- Having given consent for its biological resources to be reused for research purposes
Key exclusion criteria (1 listed)
- Subject having expressed opposition to participating in the study
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
Presence of antibodies specific to SARS-CoV2 in the serum in the subjects studied
Time frame: Through study completion, an average of 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
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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.
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 4 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 11 Jan 2024. 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 Sabrina Garnier Kepka, MD (33 3 69 55 13 35, Sabrina.GARNIER-KEPKA@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of antibodies specific to SARS-CoV2 in the serum in the subjects studied (time frame: Through study completion, an average of 2 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 11 Jan 2024.