Prognostic Value of IgM in Covid-19 Infection

NCT05092594 | Unknown

• 1 other identifier: 21JGD-COVIDM
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID-19

Keywords

Covid-19; anti SARS-Co-V-2 IgM

Outcome Measures

Primary Outcomes (2)

• 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 (6)

• Hospitalization at Ambroise Paré hospital

  through study completion, an average of 1 month

• Oxygenotherapy

  through study completion, an average of 1 month

• Ventilation

  through study completion, an average of 1 month

• Thoracic CT

  through study completion, an average of 1 month

• Patient's vital statute

  through study completion, an average of 1 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood sampling between day 1 to day 14 from first syndromes of Covid-19 infection. Serum or plasma conservations.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jean-Louis Gaillard, MD, PhD

  Microbiological Laboratory - CHU Ambroise Paré - APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Louis Gaillard, MD, PhD

CONTACT

+ 33 (0)1 49 09 55 40; jean-louis.gaillard@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 25, 2021
• Study Start: April 1, 2022
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share