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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04543006
Other study ID # EssaiClinique_PANCOLIN
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 8, 2020
Est. completion date December 31, 2021

Study information

Verified date September 2020
Source University Hospital, Grenoble
Contact Olivier Epaulard, MD,PhD
Phone 0033476765291
Email oepaulard@chu-grenoble.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 170
Est. completion date December 31, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- positive SARS-CoV-2

Exclusion Criteria:

- age under 18

- immunocompromised at the onset of Covid-19

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
serology
blood sample of 10 ml twice (6 and 12 months after the Covid-19)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

Outcome

Type Measure Description Time frame Safety issue
Primary anti-SARS-CoV-2 neutralizing antibody titers Titer in plamsa of neutralizing anti-SARS-CoV-2 antibody 1 day
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