Prognostic Value of IgM in Covid-19 Infection (COVID-M)

April 4, 2022 updated by: Assistance Publique - Hôpitaux de Paris

The Prognostic Value of IgM in Covid-19 Infection

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

October 1, 2021

First Submitted That Met QC Criteria

October 22, 2021

First Posted (Actual)

October 25, 2021

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21JGD-COVIDM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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