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

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ClinicalTrials.gov Identifier: NCT04341142
Recruitment Status : Recruiting
First Posted : April 10, 2020
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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

Condition or disease Intervention/treatment Phase
CoV2 Positive Caregivers Diagnostic Test: Serological tests will be applied on patients blood sampling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Serological Techniques for Screening Patients Regarding COVID-19-COVID-SER
Actual Study Start Date : April 9, 2020
Estimated Primary Completion Date : April 9, 2023
Estimated Study Completion Date : April 9, 2024

Arm Intervention/treatment
Experimental: Serological tests will be applied on patients blood sampling
Serological tests will be applied on patients blood sampling
Diagnostic Test: Serological tests will be applied on patients blood sampling
Application of tests on patients' serum




Primary Outcome Measures :
  1. The positivity (Yes/No) of the serological test. [ Time Frame: Day 0 ]
    The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR

  2. The positivity (Yes/No) of the serological test. [ Time Frame: Day 3 ]
    The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR

  3. The positivity (Yes/No) of the serological test. [ Time Frame: Day 7 ]
    The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR

  4. The positivity (Yes/No) of the serological test. [ Time Frame: Day 14 ]
    The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR

  5. The positivity (Yes/No) of the serological test. [ Time Frame: Day 21 ]
    The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR

  6. The positivity (Yes/No) of the serological test. [ Time Frame: Day 28 ]
    The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR

  7. The positivity (Yes/No) of the serological test. [ Time Frame: Day 35 ]
    The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR

  8. The positivity (Yes/No) of the serological test. [ Time Frame: Day 42 ]
    The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR


Secondary Outcome Measures :
  1. Measurement of IgM and IgG antibody titer at each sampling of weekly and monthly visits of covid-19+ patients and implementation of the kinetics of mean appearance. [ Time Frame: Day 42 ]
  2. - Among the symptomatic PCR negative patients recruited into the study at the first visit, the measurement of the IgM antibody and IgG titer will be performed in serum at D28, and the positive results will then constitute the false-negative PCR results. [ Time Frame: Day 28 ]
  3. - Measurement of IgM and IgG antibody titer at each sampling of late patient visits. [ Time Frame: Day 42 ]
  4. - The neutralizing capacity of the antibodies will be determined by in vitro serum neutralization tests on seropositive serum. A group of 50 patients made up of seropositive and asymptomatic caregivers at the time of infection will represent this group. [ Time Frame: Day 42 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT04341142


Contacts
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Contact: Jean-Baptiste Mr FASSIER, Dr 04 78 86 12 05 ext +33 jean-baptiste.fassier@chu-lyon.fr

Locations
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France
Hôpital Lyon Sud,Sainte Eugénie bat 4M,5, Chemin du Grand Revoyet Recruiting
Pierre-Bénite cedex, France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04341142    
Other Study ID Numbers: 69HCL20_0329
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No