Understanding mucosal immunity and diagnosing COVID-19 infections

Understanding the Determinants of Mucosal Immunity and Optimizing the Diagnosis of Infection With SARS-CoV-2 Variants

This study is trying to understand how our immune system works against COVID-19 and improve testing for the virus by looking at different groups of adults, whether they are infected or not.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Institut Pasteur (Industry-sponsored)
• Locations: 1 site (Paris)
• Trial ID: NCT05858502 on ClinicalTrials.gov

What this trial studies

This study aims to investigate the factors influencing mucosal immunity and improve the diagnosis of COVID-19 infections caused by various SARS-CoV-2 variants. It will involve adult participants who are either infected or uninfected with the virus, categorized into three groups: uninfected, asymptomatically infected, and symptomatically infected. Participants will undergo a series of sample collections, including blood, saliva, and nasal samples, over several follow-up visits to assess their immune responses. The study is conducted in collaboration with medical analysis laboratories in the Ile-de-France region.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 who reside in the Ile-de-France region and meet specific health criteria.

Not a fit: Patients with severe comorbidities or those requiring hospitalization for COVID-19 symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to enhanced diagnostic methods and better understanding of immunity against COVID-19, potentially improving patient outcomes.

How similar studies have performed: Other studies have explored similar aspects of immunity and COVID-19, indicating potential for success in this area.

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

Where this trial is running

Paris

• Institut Pasteur - ICAReB-clin — Paris, France (Recruiting)

Study contacts

• Principal investigator: Hélène Laude, MD — Institut Pasteur
• Study coordinator: Hélène Laude, MD

Conditions COVID-19