COVID-M: Prognostic Value of IgM in Covid-19 Infection

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05092594

Collaborator

(none)

500

Enrollment

Anticipated Duration (Days)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19

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".

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

The Prognostic Value of IgM in Covid-19 Infection

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Hospitalization at Ambroise Paré hospital [through study completion, an average of 1 month]
Hospitalization at Ambroise Paré hospital during SARS-CoV-2 infection
Oxygenotherapy [through study completion, an average of 1 month]
Use of high-flow oxygenotherapy
Ventilation [through study completion, an average of 1 month]
Ventilation during SARS-CoV-2 infection
Thoracic CT [through study completion, an average of 1 month]
Thoracic CT result during SARS-CoV-2 infection
Patient's vital statute [through study completion, an average of 1 month]
Death of hospitalized patients in Ambroise Paré hospital
IgM anti-SARS-Co-V-2 presence [through study completion, an average of 1 month]
IgM anti-SARS-Co-V-2 level

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Jean-Louis Gaillard, MD, PhD, Microbiological Laboratory - CHU Ambroise Paré - APHP

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT05092594

Other Study ID Numbers:

21JGD-COVIDM

First Posted:

Oct 25, 2021

Last Update Posted:

Apr 12, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Assistance Publique - Hôpitaux de Paris

Covid-19

anti SARS-Co-V-2 IgM

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Apr 12, 2022