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.

Not Applicable

Completed

• Conditions: COVID-19
• Interventions: Biological: blood sample

• Registration Number: NCT06862531
• Lead Sponsor: Bioaster

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-25
• Primary Completion: 2020-11-17
• Study Completion: 2020-11-17
• Status Verified: 2025-03
• Study First Submitted: 2025-03-05
• Study First Submitted QC: 2025-03-05
• Last Update Submitted: 2025-03-05
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Severe	blood sample	patients who developed a severe form of Covid (hospitalized in ICU in March/April 2020)

Primary Outcome Measures

Name	Time	Method
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	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)

Trial Locations

Locations (1)

CH ANnecy-GEnevois (CHANGE); 🇫🇷 Metz-tessy, Rhône Alpes, France