Persistence of Neutralizing Antibodies 6 and 12 Months Af... | NCT04543006

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

NCT04543006

Sponsor

University Hospital, Grenoble

Status

Unknown status

Last Update Posted

Sep 16, 2020Actual

Enrollment

170Estimated

Phase

Not Applicable

Conditions

Covid19

Interventions

serology

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 8, 2020Estimated

Primary Completion Date

Sep 30, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Sep 8, 2020

First Submission Date that Met QC Criteria

Sep 8, 2020

First Posted Date

Sep 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2020

Last Update Posted Date

Sep 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

170Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Covid-19	Other	only arm: Covid-19 proven by PCR	Diagnostic Test: serology

Interventions

Name	Type	Description	Arm Group Labels	Other Names
serology	Diagnostic Test	blood sample of 10 ml twice (6 and 12 months after the Covid-19)	Covid-19

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
anti-SARS-CoV-2 neutralizing antibody titers	Titer in plamsa of neutralizing anti-SARS-CoV-2 antibody	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

positive SARS-CoV-2

Exclusion Criteria:

age under 18
immunocompromised at the onset of Covid-19

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Olivier Epaulard, MD,PhD	Contact	0033476765291		oepaulard@chu-grenoble.fr

Overall Officials

Name	Affiliation	Role
Olivier Epaulard, MD,PhD	University Hospital, Grenoble	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided