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COVID-19 is a new emerging disease caused by infection with the SARS-CoV-2 coronavirus, with no specific therapeutic options.
Since the end of February 2020, the Strasbourg University Hospital (HUS) had faced a sudden increase of patients with COVID-19 resulted from a SARS-CoV-2 superspreading event (religious meeting). Infected individuals went to regional hospitals, and this led to a cluster of infected healthcare workers at the Strasbourg University Hospitals from the first week of March. To date, several hundred Strasbourg hospital workers have presented a SARS-CoV-2 infection confirmed by the RT-PCR test from a nasopharyngeal sample. Most of them developed a mild form of COVID-19.
It is important to understand how far the infection has spread in the hospital staff, and to which extent the individuals who have been infected develop antibodies against SARS-CoV-2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCR+ group | Experimental | This group includes any symptomatic person with a positive COVID result, with a RT-PCR test carried out at least 10 days before inclusion. |
|
| PCR- group | Experimental | This group includes any symptomatic person with a negative RT-PCR COVID 19 test carried out at least 10 days before inclusion. |
|
| No PCR | Experimental | This group includes any person, for which no COVID 19 RT- PCR testing was performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample for serological test | Diagnostic Test | Serology tests:
Confirmation test by seroneutralization tests developed at the Strasbourg Virology laboratory on whole virus (analyzes performed in a biosafety level 3 laboratory) and by the viral pseudoparticles system, will be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of specific SARS-CoV2 antibodies in the serum in the 3 groups of subjects studied, at the inclusion visit (D0). | Presence of specific SARS-CoV2 antibodies in the serum in the 3 groups of subjects studied, at the inclusion visit (D0). | inclusion visit (Day 0). |
| Measure | Description | Time Frame |
|---|---|---|
| Detection and titration of neutralizing antibodies anti-SARS-CoV-2 | At Day 0 and each follow-up visits i.e. at Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) and Month 12 (Day 0+12 months). | |
| Kinetics of antibodies and their persistence over a period of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of the T cell response by the ELISPOT technique | At one of the follow up visit : Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) or Month 12 (Day 0+12 months). | |
| B cell repertoire sequencing | At one of the follow up visit : Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) or Month 12 (Day 0+12 months). |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires de Strasbourg - Centre d'Investigation Clinique - Nouvel Hôpital Civil et Hautepierre | Strasbourg | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35891471 | Background | Garcia L, Woudenberg T, Rosado J, Dyer AH, Donnadieu F, Planas D, Bruel T, Schwartz O, Prazuck T, Velay A, Fafi-Kremer S, Batten I, Reddy C, Connolly E, McElheron M, Kennelly SP, Bourke NM, White MT, Pelleau S. Kinetics of the SARS-CoV-2 Antibody Avidity Response Following Infection and Vaccination. Viruses. 2022 Jul 8;14(7):1491. doi: 10.3390/v14071491. | |
| 34455390 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D012698 | Serologic Tests |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| At Day 0 and each follow-up visits i.e. at Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) and Month 12 (Day 0+12 months). |
| Number of asymptomatic subjects in the PCR - and -PCR groups | At Day 0 and each follow-up visits i.e. at Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) and Month 12 (Day 0+12 months). |
| Number of people with positive Sars-CoV-2 serology | At Day 0 and each follow-up visits i.e. at Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) and Month 12 (Day 0+12 months). |
| Questionnaire (Type of health care personnel, Contact history, medical operation and respect of hygiene standards) | At Day 0 and each follow-up visits i.e. at Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) and Month 12 (Day 0+12 months). |
| Sequencing of cellular SARS-CoV2 receptors | At one of the follow up visit : Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) or Month 12 (Day 0+12 months). |
| Gallais F, Gantner P, Bruel T, Velay A, Planas D, Wendling MJ, Bayer S, Solis M, Laugel E, Reix N, Schneider A, Glady L, Panaget B, Collongues N, Partisani M, Lessinger JM, Fontanet A, Rey D, Hansmann Y, Kling-Pillitteri L, Schwartz O, De Seze J, Meyer N, Gonzalez M, Schmidt-Mutter C, Fafi-Kremer S. Evolution of antibody responses up to 13 months after SARS-CoV-2 infection and risk of reinfection. EBioMedicine. 2021 Sep;71:103561. doi: 10.1016/j.ebiom.2021.103561. Epub 2021 Aug 27. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D007159 | Immunologic Tests |
| D007158 | Immunologic Techniques |