A Single-center, Interventional Diagnostic Study With Minimal Risks and Constraints, Aimed at Longitudinally Evaluating Serum Antibody Levels in Patients With COVID-19 According to the Severity of Their Symptoms.

NCT06862531 | Completed

• 1 other identifier: 2020-A02008-31
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The COVERT protocol was designed to assess, through a longitudinal analysis, the level of antibodies present in the serum of patients with COVID-19, the duration and the persistence of the humoral response in correlation with the severity of the disease.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• The correlation between serum antibody levels (IgM/IgG), the stage of the disease (in relation to the onset date of symptoms), and the severity of the disease (severe form versus moderate form)

  The correlation between serum antibody levels (IgM/IgG), the stage of the disease (in relation to the onset date of symptoms), and the severity of the disease (severe form versus moderate form)

  10month after inclusion

Study Arms (1)

Severe

OTHER

patients who developed a severe form of Covid (hospitalized in ICU in March/April 2020)

Biological: blood sample

Interventions

blood sample BIOLOGICAL

A sample of blood (1mL) was taken

Severe

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years old,
• Patient whose Covid-19 diagnosis has been confirmed by RT-PCR test (SARS-CoV-2 positive) from a nasopharyngeal swab/broncho alveolar lavage
• Patient whose severity of Covid-19 required hospital treatment
• Patient whose Covid-19 form is defined as moderate (stay in general ward) or severe (stay in ICU), based on the clinical evaluation conducted by the doctor
• Patient agreeing to participate in the study and having signed the informed consent.

You may not qualify if:

• Adult person subject to legal protection,
• Pregnant, parturient or breastfeeding woman
• Person not affiliated to a social security scheme or not beneficiary of such a scheme
• Person subject to a safeguard measure
• Person deprived of liberty by a judicial or administrative decision and woman hospitalized without consent under Articles L.3212-1 and 3213-1, which do not fall under Article L.1122-8 of the Public Health Code.

Sponsors & Collaborators

• Bioaster: lead

Study Sites (1)

CH ANnecy-GEnevois (CHANGE)

Metz-Tessy, Auvergne-Rhône-Alpes, 74370, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 6, 2025
• Study Start: September 25, 2020
• Primary Completion: November 17, 2020
• Study Completion: November 17, 2020
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

FR (1)