Prognostic Value of IgM in Covid-19 Infection

COVID-19 Clinical Trial

— COVID-M  

Official title:

The Prognostic Value of IgM in Covid-19 Infection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05092594
• Other study ID #: 21JGD-COVIDM
• Status: Not yet recruiting
• Start date: April 2022
• Est. completion date: May 2022

Study information

• Verified date: March 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Jean-Louis Gaillard, MD, PhD
• Phone: + 33 (0)1 49 09 55 40
• Email: jean-louis.gaillard[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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".

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization	Absence of hospitalization versus hospitalization without ventilation during SARS-CoV-2 infection	through study completion, an average of 1 month
Primary	Ventilation	Non ventilation versus ventilation during Covid-19 hospitalization	through study completion, an average of 1 month
Secondary	Hospitalization at Ambroise Paré hospital	Hospitalization at Ambroise Paré hospital during SARS-CoV-2 infection	through study completion, an average of 1 month
Secondary	Oxygenotherapy	Use of high-flow oxygenotherapy	through study completion, an average of 1 month
Secondary	Ventilation	Ventilation during SARS-CoV-2 infection	through study completion, an average of 1 month
Secondary	Thoracic CT	Thoracic CT result during SARS-CoV-2 infection	through study completion, an average of 1 month
Secondary	Patient's vital statute	Death of hospitalized patients in Ambroise Paré hospital	through study completion, an average of 1 month
Secondary	IgM anti-SARS-Co-V-2 presence	IgM anti-SARS-Co-V-2 level	through study completion, an average of 1 month