Sars-CoV2SEROCOVNCT04304690
COVID-19 Seroconversion Among Front Line Medical and Paramedical Staff in Emergency, Intensive Care Units and Infectious Disease Departments During the 2020 Epidemic
A study testing blood sample in people with Sars-CoV2, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The epidemic due to the Sars-CoV2 virus is spreading in France, without knowning precisely since when the virus has actually circulated on the territory. Data from China but also systematic samples taken from the passengers of the Diamond Princess boat also report almost 50% of asymptomatic forms of Covid-19. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sars-CoV2
- What is being tested?
- blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,177 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2020to 7 Jul 2021
- Phase
- Interventional
- 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
Who may be able to join
- Any permanent medical or paramedic staff of participating services who have given written consent to participate
- Having a social security insurance.
Who cannot join
- Non-permanent staff (occasional staffing), administrative staff, technical staff of participating services.
- Staff who were not active during the inclusion period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 Seroconversion Among Medical and Paramedical Staff in Emergency, ICU and Infectious Disease Services During the 2020 Epidemic
The epidemic due to the Sars-CoV2 virus is spreading in France, without knowning precisely since when the virus has actually circulated on the territory. Data from China but also systematic samples taken from the passengers of the Diamond Princess boat also report almost 50% of asymptomatic forms of Covid-19. The medical and paramedical staff of the front-line services for the care of patients infected with Covid-19 are in fact potentially exposed to the risk of occupational contamination due to the large number of patients treated, including in the pre-epidemic phase. Therefore, and despite the application of standard protective measures, it is possible that a certain number of these personnel already have or will contract Covid-19 disease, including in its asymptomatic form.
Read the detailed description
The epidemic due to Sars-CoV2 is spreading in France, without it being knowning precisely since when the virus actually circulated on the territory. Data from China but also systematic samples taken from the passengers of the boat Diamond Princess also report almost 50% of asymptomatic forms of Covid-19. Medical and paramedical staff are in fact potentially exposed to the risk of professional contamination, with probably a different risk between the first-line referent hospitals and the others, due to the large number of patients treated in the first, including in the pre-epidemic phase (average of 190 consultants per day at the emergency department Pitié-Salpêtrière for example). Therefore, and despite the application of standard protective measures, it is possible that a certain number of these personnel already have or will contract Covid-19 disease, including in its asymptomatic form. Knowledge of this seroconversion rate, if it is found to be higher than that of the general population, could lead to a review of the measures to protect personnel from other emerging infectious risks.
- Conditions
- Sars-CoV2
- Being tested
- blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
2 blood samples at T0 and 3 months
| Study group | Role | What they receive |
|---|---|---|
| caregiver | Other | caregivers from emergency, ICU, virology and infectious disease services Receives: Other: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantify the proportion of patients with documented Sars-CoV2 infection among medical and paramedical staff
Sars-CoV2 seroconversion is defined by a T0 sample with no specific antibody (negative) and M3 sample with the presence of specific IgG.
Measured: 3 months
Secondary outcomes (3)
Identification of risk factors for seroconversion
"Age, gender, type of staff, medical staff: resident, Clinic Chief or University Hospital Assistant (CCA / AHU), Associate Practitioner (PA), Contractual Hospital Practitioner (PHC), Hospital Practitioner (PH), Lecturer-Hospital Practitioner (MCU-PH) , University Professor-Hospital Practitioner (PUPH) non-medical staff: nursing assistants (AS), nurses (IDE), physiotherapist, managers, others, Seniority in the profession (number of years) Service tenure (years), Night, day, day or mixed work, Type of service: emergency department, infectious disease service, ICU), Type of hospital (firstline reference hospital or not), Documented contact with a confirmed patient."
Measured: 3 months
Quantify the proportion of asymptomatic infections among staff who have seroconverted
"Seroconversion without clinical manifestation (fever, body aches, headache, sweating, chills + respiratory symptoms (cough dyspnea, sputum) or digestive (nausea / vomiting diarrhea abdominal pain) reported via the weekly self-monitoring booklet.
The asymptomatic characteristics will be determined by an adjudication committee, in the light of the weekly self-monitoring notebooks, without knowing the results of the serologies."
Measured: 3 months
" Describe symptomatic infections for personnel developing acute clinical (respiratory or digestive) viral syndrome "
"Description of symptomatic infections
- Clinical manifestations associated with seroconversion.
- On the intermediate sample if necessary, performed within 10 days of the start of a clinical picture compatible with an acute Sars-CoV2 infection (fever, body aches, headache, sweating, chills + respiratory picture (cough dyspnea, sputum, ) or digestive (nausea / vomiting diarrhea abdominal pain) "
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 posted11 Mar 2020
- Study start16 Mar 2020
- Primary completion7 Jul 2021
- Study completion7 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304690
- Sponsor's protocol ID
- APHP200310
- Acronym
- SEROCOV
- Status last verified
- Jul 2022
- First submitted
- 9 Mar 2020
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hausfater P, Boutolleau D, Lacombe K, Beurton A, Dumont M, Constantin JM, Ghosn J, Combes A, Cury N, Guedj R, Djibre M, Bompard R, Mazerand S, Pourcher V, Gimeno L, Marois C, Teyssou E, Marcelin AG, Hajage D, Tubach F. Cumulative incidence of SARS-CoV-2 infection and associated risk factors among frontline health care workers in Paris: the SEROCOV cohort study. Sci Rep. 2022 May 4;12(1):7211. doi: 10.1038/s41598-022-10945-y.
PubMed 35508515
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Seroconversion Among Medical and Paramedical Staff in Emergency, ICU and Infectious Disease Services During the 2020 Epidemic
- ClinicalTrials.gov ID
- NCT04304690
- Acronym / sponsor ID
- SEROCOV / APHP200310
- Conditions
- Sars-CoV2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,177 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 16 Mar 2020 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 11 Mar 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 epidemic due to the Sars-CoV2 virus is spreading in France, without knowning precisely since when the virus has actually circulated on the territory. Data from China but also systematic samples taken from the passengers of the Diamond Princess boat also report almost 50% of asymptomatic forms of Covid-19. The medical and paramedical staff of the front-line services for the care of patients infected with Covid-19 are in fact potentially exposed to the risk of occupational contamination due to the large number of patients treated, including in the pre-epidemic phase. Therefore, and despite the application of standard protective measures, it is possible that a certain number of these personnel already have or will contract Covid-19 disease, including in its asymptomatic form.
Detailed description
The epidemic due to Sars-CoV2 is spreading in France, without it being knowning precisely since when the virus actually circulated on the territory. Data from China but also systematic samples taken from the passengers of the boat Diamond Princess also report almost 50% of asymptomatic forms of Covid-19. Medical and paramedical staff are in fact potentially exposed to the risk of professional contamination, with probably a different risk between the first-line referent hospitals and the others, due to the large number of patients treated in the first, including in the pre-epidemic phase (average of 190 consultants per day at the emergency department Pitié-Salpêtrière for example). Therefore, and despite the application of standard protective measures, it is possible that a certain number of these personnel already have or will contract Covid-19 disease, including in its asymptomatic form. Knowledge of this seroconversion rate, if it is found to be higher than that of the general population, could lead to a review of the measures to protect personnel from other emerging infectious risks.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| caregiver | Other | Other: blood samplecaregivers from emergency, ICU, virology and infectious disease services |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Any permanent medical or paramedic staff of participating services who have given written consent to participate
- Having a social security insurance.
Key exclusion criteria (2 listed)
- Non-permanent staff (occasional staffing), administrative staff, technical staff of participating services.
- Staff who were not active during the inclusion period.
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 |
|---|---|---|
| blood sample2 blood samples at T0 and 3 months | Other | caregiver |
Primary outcome
Quantify the proportion of patients with documented Sars-CoV2 infection among medical and paramedical staff
Time frame: 3 months
Sars-CoV2 seroconversion is defined by a T0 sample with no specific antibody (negative) and M3 sample with the presence of specific IgG.
3 secondary outcomes
Identification of risk factors for seroconversion
Time frame: 3 months
Quantify the proportion of asymptomatic infections among staff who have seroconverted
Time frame: 3 months
" Describe symptomatic infections for personnel developing acute clinical (respiratory or digestive) viral syndrome "
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 6 Jul 2022.
- Derived from this study: PubMed 35508515Hausfater P, Boutolleau D, Lacombe K, Beurton A, Dumont M, Constantin JM, Ghosn J, Combes A, Cury N, Guedj R, Djibre M, Bompard R, Mazerand S, Pourcher V, Gimeno L, Marois C, Teyssou E, Marcelin AG, Hajage D, Tubach F. Cumulative incidence of SARS-CoV-2 infection and associated risk factors among frontline health care workers in Paris: the SEROCOV cohort study. Sci Rep. 2022 May 4;12(1):7211. doi: 10.1038/s41598-022-10945-y.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample in people with Sars-CoV2, run by Assistance Publique - Hôpitaux de Paris 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 6 Jul 2022. 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?
Quantify the proportion of patients with documented Sars-CoV2 infection among medical and paramedical staff (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04304690, which also lists 1 linked publication.
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 6 Jul 2022.