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Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19 (PANCOLIN)

Primary Purpose

Covid19

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
serology
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19 focused on measuring neutralizing antibodies, long-term persistence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • positive SARS-CoV-2

Exclusion Criteria:

  • age under 18
  • immunocompromised at the onset of Covid-19

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Covid-19

    Arm Description

    only arm: Covid-19 proven by PCR

    Outcomes

    Primary Outcome Measures

    anti-SARS-CoV-2 neutralizing antibody titers
    Titer in plamsa of neutralizing anti-SARS-CoV-2 antibody

    Secondary Outcome Measures

    Full Information

    First Posted
    September 8, 2020
    Last Updated
    September 11, 2020
    Sponsor
    University Hospital, Grenoble
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04543006
    Brief Title
    Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19
    Acronym
    PANCOLIN
    Official Title
    Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 8, 2020 (Anticipated)
    Primary Completion Date
    September 30, 2021 (Anticipated)
    Study Completion Date
    December 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Grenoble

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Covid-19 is associated with the onset of anti-SARS-CoV-2 antibodies; in a majority of patients, neutralizing antibodies are detected. However, the long-term persistence of such protective antibodies is not known. The investigators will explore patients with a proven Covid-19 (positive PCR) 6 and 12 months after the diagnosis to determine whether neutralizing antibodies are still detected. The investigators will determine whether this persistance varies according to the severity of the Covid-19 a treatment by steroids during the covid-19. This will help to anticipate whether a second wave of infection is possible in a non-naive population.
    Detailed Description
    Covid-19 is associated with the onset of anti-SARS-CoV-2 antibodies; in a majority of patients, neutralizing antibodies are detected. However, the long-term persistence of such protective antibodies is not known. The investigators will explore adult patients with a proven Covid-19 (positive PCR) 6 and 12 months after the diagnosis to determine whether neutralizing antibodies are still detected. The investigators will determine whether this persistance varies according to the severity of the Covid-19 (3 groups: no oxyegn therapy; oxygen therapy of less than 3L/min; oxygen therapy of 3L/min or more) a treatment by steroids during the covid-19. Immunocompromised patients will be excluded.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Covid19
    Keywords
    neutralizing antibodies, long-term persistence

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Model Description
    sample of patients 6 and 12 months after the acute disease
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    170 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Covid-19
    Arm Type
    Other
    Arm Description
    only arm: Covid-19 proven by PCR
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    serology
    Intervention Description
    blood sample of 10 ml twice (6 and 12 months after the Covid-19)
    Primary Outcome Measure Information:
    Title
    anti-SARS-CoV-2 neutralizing antibody titers
    Description
    Titer in plamsa of neutralizing anti-SARS-CoV-2 antibody
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: positive SARS-CoV-2 Exclusion Criteria: age under 18 immunocompromised at the onset of Covid-19
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Olivier Epaulard, MD,PhD
    Phone
    0033476765291
    Email
    oepaulard@chu-grenoble.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Olivier Epaulard, MD,PhD
    Organizational Affiliation
    University Hospital, Grenoble
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19

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