Developement and Evaluation of Serological Assays for COV... | NCT04377763

Studies
Developement and Evaluation of Serological Assays for COVID-19

NCT04377763

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Feb 25, 2021Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

COVID-19

Interventions

Not provided

Countries

France

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

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2020Actual

Primary Completion Date

Mar 2021Estimated

Completion Date

Mar 2021Estimated

First Submitted Date

May 5, 2020

First Submission Date that Met QC Criteria

May 5, 2020

First Posted Date

May 6, 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

Feb 24, 2021

Last Update Posted Date

Feb 25, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The primary objective of the study aims to evaluate serological assays of virus Covid-19.

Detailed Description

This is a retrospective monocentric study, which will include the patients who have hospitalized in Ambroise Paré Hospital and have sampling sent to the Laboratory of Microbiology of the hospital between the 15 March 2020 and 30 september 2020.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensibility and specificity	Determination of sensibility and specificity of serological testing in SARS-CoV-2 virus in patients with acute respiratory symptoms.	Throughout of the study, an average of 6 months

Secondary Outcomes

Measure	Description	Time Frame
Delay between the first symptoms and the positive serological result	Delay between the first symptoms and the positive serological result of SARS-CoV-2 virus.	Throughout of the study, an average of 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient ≥ 18 years;
Have molecular diagnosis of positive or negative result in Covid-19 virus by the Laboratory of Microbiology in Ambroise Paré Hospital;
Have diagnosed of a viral infection in respiratory.

Exclusion Criteria:

- Patient refusal.

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

Adult patients with positive or negative molecular diagnosis of Covid-19, in the Laboratory of Microbiology of Ambroise Paré Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marie-Anne RAMEIX-WELTI, MD, PhD	Contact	+33 (0)6 65 13 64 34		marie-anne.welti@aphp.fr

Overall Officials

Name	Affiliation	Role
Marie-Anne RAMEIX-WELTI, MD, PhD	Laboratoire de Microbiologie Hygiène hospitalière, Hôpital Ambroise paré, APHP	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laboratory of microbiology of hospital hygiene, Ambroise Paré Hospital, APHP	Recruiting	Boulogne-Billancourt		92100	France

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