COVID-19 Seroconversion Among Front Line Medical and Paramedical Staff in Emergency, Intensive Care Units and Infectious Disease Departments During the 2020 Epidemic (SEROCOV)
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|ClinicalTrials.gov Identifier: NCT04304690|
Recruitment Status : Active, not recruiting
First Posted : March 11, 2020
Last Update Posted : December 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sars-CoV2||Other: blood sample||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||COVID-19 Seroconversion Among Medical and Paramedical Staff in Emergency, ICU and Infectious Disease Services During the 2020 Epidemic|
|Actual Study Start Date :||March 16, 2020|
|Estimated Primary Completion Date :||May 16, 2021|
|Estimated Study Completion Date :||October 16, 2021|
caregivers from emergency, ICU, virology and infectious disease services
Other: blood sample
2 blood samples at T0 and 3 months
- 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.
- Identification of risk factors for seroconversion [ Time Frame: 3 months ]"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."
- Quantify the proportion of asymptomatic infections among staff who have seroconverted [ Time Frame: 3 months ]
"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."
- " Describe symptomatic infections for personnel developing acute clinical (respiratory or digestive) viral syndrome " [ Time Frame: 3 months ]
"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) "
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04304690
|Hopital Pitié Salpetrière|
|Paris, France, 75013|