Assessment of Serological Techniques for Screening Patients Regarding COVID-19-COVID-SER

NCT ID: NCT04341142

Last Updated: 2024-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-10

Study Completion Date

2026-10-10

Brief Summary

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

Detailed Description

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Conditions

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CoV2 Positive Caregivers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Serological tests will be applied on patients blood sampling

Serological tests will be applied on patients blood sampling

Group Type EXPERIMENTAL

Serological tests will be applied on patients blood sampling

Intervention Type DIAGNOSTIC_TEST

Application of tests on patients' serum

Interventions

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Serological tests will be applied on patients blood sampling

Application of tests on patients' serum

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Lyon Sud,Sainte Eugénie bat 4M,5, Chemin du Grand Revoyet

Pierre-Bénite, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 33450388 (View on PubMed)

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.

Reference Type RESULT
PMID: 34294751 (View on PubMed)

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.

Reference Type RESULT
PMID: 34673755 (View on PubMed)

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.

Reference Type RESULT
PMID: 33234651 (View on PubMed)

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.

Reference Type RESULT
PMID: 36173972 (View on PubMed)

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.

Reference Type RESULT
PMID: 33399823 (View on PubMed)

Other Identifiers

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69HCL20_0329

Identifier Type: -

Identifier Source: org_study_id

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