NCT04543006

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable covid19

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

September 8, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

1.1 years

First QC Date

September 8, 2020

Last Update Submit

September 11, 2020

Conditions

Covid19

Keywords

neutralizing antibodieslong-term persistence

Outcome Measures

Primary Outcomes (1)

  • anti-SARS-CoV-2 neutralizing antibody titers

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

    1 day

Study Arms (1)

Covid-19

OTHER

only arm: Covid-19 proven by PCR

Diagnostic Test: serology

Interventions

serologyDIAGNOSTIC_TEST

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

Covid-19

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • positive SARS-CoV-2

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Olivier Epaulard, MD,PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier Epaulard, MD,PhD

CONTACT

0033476765291oepaulard@chu-grenoble.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: sample of patients 6 and 12 months after the acute disease
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2020

First Posted

September 9, 2020

Study Start

September 8, 2020

Primary Completion

September 30, 2021

Study Completion

December 31, 2021

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share