Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT05858502
Eligibility Criteria:
Inclusion Criteria:
* Common criteria for all subjects:
* Aged between 18 and 65 years included
* Whose weight is greater than or equal to 50 kg and whose state of health is compatible with the collection of 55 ml of blood at one time and 111 ml in 28 days
* Residing in the Ile-de-France region and able to travel to the 15th arrondissement of Paris for visits to ICAReB-Clin
* Having given their consent to participate in the study
* Benefiting from a Social Security scheme except for the Aide Médicale d'Etat
* Criteria for the SARS-CoV-2 infected participant group:
* Subject tested positive for SARS-CoV-2 by RT-PCR in one of the participating laboratories for less than 72 hours
* Asymptomatic or with symptoms not requiring hospitalization regardless of previous vaccination or infection status for SARS-CoV-2.
* Criteria for the SARS-CoV-2 uninfected group:
* Having tested negative for SARS-CoV-2 by RT-PCR
* Subject with no more than 3 co-morbidities listed by the HAS.
Exclusion Criteria:
* Criteria common to all subjects :
* Subject under a protective measure (e.g., guardianship)
* Participant in another biomedical research
* For women: pregnant or breastfeeding women (declarative)
* Subject with another acute infectious disease
* SARS-CoV-2 RT-PCR result older than 3 days
* Existence of at least 3 co-morbidities known to be factors of severity (and therefore representing risks of hospitalisation during follow-up)
* Existence of a previous known SARS-CoV-2 positivity less than 1 month old (whatever the method used: RT-PCR or antigenic test)
* SARS-CoV-2 infected participant group criteria:
\- For symptomatic subjects: onset of symptoms more than 4 days ago
* SARS-CoV-2 uninfected participant group criteria:
* Known history of infection and/or COVID-19 vaccination, within the previous 3 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05858502
Study Brief:
Protocol Section:
NCT05858502