Prognostic Value of IgM in Covid-19 Infection

• Conditions: COVID-19

• Registration Number: NCT05092594
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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".

Study Timeline

• Study First Submitted: 2021-10-01
• Study First Submitted QC: 2021-10-22
• Study First Posted: 2021-10-25
• Status Verified: 2022-03
• Study Start: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-12
• Primary Completion: 2022-05
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
IgM anti-SARS-Co-V-2 presence	through study completion, an average of 1 month	IgM anti-SARS-Co-V-2 level
Ventilation	through study completion, an average of 1 month	Ventilation during SARS-CoV-2 infection
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
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