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
About this trial
This is an interventional prevention trial for Covid19 focused on measuring neutralizing antibodies, long-term persistence
Eligibility Criteria
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
NCT ID
NCT04543006
First Posted
September 8, 2020
Last Updated
September 11, 2020
Sponsor
University Hospital, Grenoble
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
We'll reach out to this number within 24 hrs