Prognostic Value of IgM in Covid-19 Infection | NCT05092594

Studies
Prognostic Value of IgM in Covid-19 Infection

NCT05092594

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Apr 12, 2022Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

COVID-19

Interventions

Not provided

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

Mar 2022

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

Apr 2022Estimated

Primary Completion Date

May 2022Estimated

Completion Date

May 2022Estimated

First Submitted Date

Oct 1, 2021

First Submission Date that Met QC Criteria

Oct 22, 2021

First Posted Date

Oct 25, 2021Actual

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

Apr 4, 2022

Last Update Posted Date

Apr 12, 2022Actual

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 research is to study the relation between the presence and /or the anti SARS-Co-V-2 IgM level in an early stage of COVID-19 infection, and the evolution of the illness.

Detailed Description

The secondary objective is to determinate in what manner response of IgM anti-SARS-Co-V-2 relates to patient's immunity statute, in regards to the other so-called humain "seasonal coronavirus".

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

Retention

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospitalization	Absence of hospitalization versus hospitalization without ventilation during SARS-CoV-2 infection	through study completion, an average of 1 month
Ventilation	Non ventilation versus ventilation during Covid-19 hospitalization	through study completion, an average of 1 month

Secondary Outcomes

Measure	Description	Time Frame
Hospitalization at Ambroise Paré hospital	Hospitalization at Ambroise Paré hospital during SARS-CoV-2 infection	through study completion, an average of 1 month
Oxygenotherapy	Use of high-flow oxygenotherapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients ≥ 18 years;
Have been diagnosed positive of SARS-CoV-2 in the Virological Laboratory of Ambroise Paré hospital;
Have been blood sampled between 1 day and 14 days from the first clinical syndromes, and their collections of serum or plasma are conserved and accessible;
Affiliated to the social security scheme or entitled;
Informed and non-opposed to participating to the study.

Exclusion Criteria:

Opposition of patient to participation to the study;
Foreign patients under french AME scheme.

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 SARS-CoV-2 positive patients who have blood sampling between 1 day and 14 days from the first clinical syndromes and their collections of serum or plasma are accessible.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jean-Louis Gaillard, MD, PhD	Contact	+ 33 (0)1 49 09 55 40		jean-louis.gaillard@aphp.fr

Overall Officials

Name	Affiliation	Role
Jean-Louis Gaillard, MD, PhD	Microbiological Laboratory - CHU Ambroise Paré - APHP	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