Clinical trial NCT04341142: Assessment of Serological Techniques for Screening Patients Regarding COVID-19-COVID-SER
Official title: Assessment of Serological Techniques for Screening Patients Regarding COVID-19-COVID-SER
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: CoV2 Positive Caregivers
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Covid-SER is a prospective multi-center study for the evaluation of diagnostic performance of available serological tests


Eligibility criteria: Inclusion Criteria:

* Seropositive caregivers screened for anti-SARS CoV2 antibodies during their consultation at the occupational medicine of HCL.
* Age: ≥ 18 years old
* Persons having given their written consent and accepting a follow-up every 6 months for 24 months, followed by a final visit at 36 months.
* Persons affiliated to a social security scheme or beneficiary of such a scheme.

Exclusion Criteria:

* Pregnant or lactating woman

Primary outcomes:
measure: The positivity (Yes/No) of the serological test.
timeFrame: Day 0
measure: The positivity (Yes/No) of the serological test.
timeFrame: Day 3
measure: The positivity (Yes/No) of the serological test.
timeFrame: Day 7
measure: The positivity (Yes/No) of the serological test.
timeFrame: Day 14
measure: The positivity (Yes/No) of the serological test.
timeFrame: Day 21
measure: The positivity (Yes/No) of the serological test.
timeFrame: Day 28
measure: The positivity (Yes/No) of the serological test.
timeFrame: Day 35
measure: The positivity (Yes/No) of the serological test.
timeFrame: Day 42
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite cedex
country: France
facility: Hôpital Lyon Sud,Sainte Eugénie bat 4M,5, Chemin du Grand Revoyet
Study officials:
References:
citation: Bal A, Trabaud MA, Fassier JB, Rabilloud M, Saker K, Langlois-Jacques C, Guibert N, Paul A, Alfaiate D, Massardier-Pilonchery A, Pitiot V, Morfin-Sherpa F, Lina B, Pozzetto B, Trouillet-Assant S; COVID SER Study Group. Six-month antibody response to SARS-CoV-2 in healthcare workers assessed by virus neutralization and commercial assays. Clin Microbiol Infect. 2021 Jun;27(6):933-935. doi: 10.1016/j.cmi.2021.01.003. Epub 2021 Jan 13. No abstract available.
citation: Bal A, Brengel-Pesce K, Gaymard A, Queromes G, Guibert N, Frobert E, Bouscambert M, Trabaud MA, Allantaz-Frager F, Oriol G, Cheynet V, d'Aubarede C, Massardier-Pilonchery A, Buisson M, Lupo J, Pozzetto B, Poignard P, Lina B, Fassier JB, Morfin F, Trouillet-Assant S; COVID-SER Study group. Clinical and laboratory characteristics of symptomatic healthcare workers with suspected COVID-19: a prospective cohort study. Sci Rep. 2021 Jul 22;11(1):14977. doi: 10.1038/s41598-021-93828-y.
citation: Pozzetto B, Legros V, Djebali S, Barateau V, Guibert N, Villard M, Peyrot L, Allatif O, Fassier JB, Massardier-Pilonchery A, Brengel-Pesce K, Yaugel-Novoa M, Denolly S, Boson B, Bourlet T, Bal A, Valette M, Andrieu T, Lina B; Covid-Ser study group; Cosset FL, Paul S, Defrance T, Marvel J, Walzer T, Trouillet-Assant S. Immunogenicity and efficacy of heterologous ChAdOx1-BNT162b2 vaccination. Nature. 2021 Dec;600(7890):701-706. doi: 10.1038/s41586-021-04120-y. Epub 2021 Oct 21.
citation: Trouillet-Assant S, Albert Vega C, Bal A, Nazare JA, Fascia P, Paul A, Massardier-Pilonchery A, D Aubarede C, Guibert N, Pitiot V, Lahousse M, Boibieux A, Makhloufi D, Simon C, Rabilloud M, Trabaud MA, Gueyffier F, Fassier JB; COVID-SER study group. Assessment of serological techniques for screening patients for COVID-19 (COVID-SER): a prospective, multicentric study. BMJ Open. 2020 Nov 24;10(11):e041268. doi: 10.1136/bmjopen-2020-041268.
citation: de Boer J, Saade U, Granjon E, Trouillet-Assant S, Saade C, Pottel H, Zrein M; Covid ser study group. A novel assessment method for COVID-19 humoral immunity duration using serial measurements in naturally infected and vaccinated subjects. PLoS One. 2022 Sep 29;17(9):e0274553. doi: 10.1371/journal.pone.0274553. eCollection 2022.
citation: Bal A, Pozzetto B, Trabaud MA, Escuret V, Rabilloud M, Langlois-Jacques C, Paul A, Guibert N, D'Aubarede-Frieh C, Massardier-Pilonchery A, Fabien N, Goncalves D, Boibieux A, Morfin-Sherpa F, Pitiot V, Gueyffier F, Lina B, Fassier JB, Trouillet-Assant S; COVID SER Study Group. Evaluation of High-Throughput SARS-CoV-2 Serological Assays in a Longitudinal Cohort of Patients with Mild COVID-19: Clinical Sensitivity, Specificity, and Association with Virus Neutralization Test. Clin Chem. 2021 Apr 29;67(5):742-752. doi: 10.1093/clinchem/hvaa336.