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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • 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

    Recruiting

Other trials in France

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.

  1. 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.

  1. First posted11 Jan 2024
  2. Study start10 Jan 2021
  3. Primary completionJan 2024 (estimated)
  4. Study completionJan 2024 (estimated)

Resources

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)
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

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.

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