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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04543006
Recruitment Status : Not yet recruiting
First Posted : September 9, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Description
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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.

Condition or disease Intervention/treatment Phase
Covid19 Diagnostic Test: serology Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: sample of patients 6 and 12 months after the acute disease
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19
Estimated Study Start Date : September 8, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Covid-19
only arm: Covid-19 proven by PCR
 Diagnostic Test: serology
blood sample of 10 ml twice (6 and 12 months after the Covid-19)


Outcome Measures
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Primary Outcome Measures :
  1. anti-SARS-CoV-2 neutralizing antibody titers [ Time Frame: 1 day ]
    Titer in plamsa of neutralizing anti-SARS-CoV-2 antibody


Eligibility Criteria
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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:

  • positive SARS-CoV-2

Exclusion Criteria:

  • age under 18
  • immunocompromised at the onset of Covid-19
Contacts and Locations
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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): NCT04543006


Contacts
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Contact: Olivier Epaulard, MD,PhD 0033476765291 oepaulard@chu-grenoble.fr

Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Olivier Epaulard, MD,PhD University Hospital, Grenoble
More Information
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT04543006    
Other Study ID Numbers: EssaiClinique_PANCOLIN
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 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
Keywords provided by University Hospital, Grenoble:
neutralizing antibodies
long-term persistence
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases