Understanding mucosal immunity and diagnosing COVID-19 infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Institut Pasteur - ICAReB-clin
  Paris, France Recruiting

Study contacts

• Principal investigator: Hélène Laude, MD — Institut Pasteur
• Study coordinator: Hélène Laude, MD
• Email: helene.laude@pasteur.fr
• Phone: 33145688394

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) in Adults

  This study tests and compares the immune responses and tolerability of the latest COVID-19 vaccines from Novavax and Pfizer/BioNTech in adults at risk for severe COVID-19.

  Recruiting Phase 4 Henry M. Jackson Foundation for the Advancement of Military Medicine · Bethesda, Maryland · NCT07287137

• Omicron-based COVID-19 vaccine with Matrix-M given as a single dose in older adults and high-risk individuals

  A single-dose Omicron-subvariant vaccine with Matrix-M is tested to see if it is safe and can induce an immune response in adults 65+ and in younger adults with conditions that raise the risk of severe COVID-19, who were previously vaccinated.

  Recruiting at 20 sites Phase 4 Sanofi · Fair Oaks, California and 19 other locations · NCT07861542

• Secutrelvir for nonhospitalized COVID-19 in teens and adults

  This study tests whether secutrelvir can help nonhospitalized people with COVID-19 see faster symptom relief compared with a placebo.

  Recruiting Phase 3 Shionogi Inc. · Multiple Locations · NCT07746544

• Virological Monitoring of Seasonal Respiratory Infections in France

  This project tests how often common respiratory viruses show up in patients seen by primary care doctors in metropolitan France during the fall and winter.

  Recruiting Institut National de la Santé Et de la Recherche Médicale, France · Paris · NCT07599449

• COVID-19 Registry at San Matteo (SMACORE) - patient-matching observational registry

  This registry tests how COVID-19 patients are being treated and progress across San Matteo in Pavia to understand patterns and outcomes.

  Recruiting Fondazione IRCCS Policlinico San Matteo di Pavia · Pavia · NCT07597876

• MDX2301 in healthy adults and adults at higher risk for severe COVID-19

  This study will try single and repeat doses of MDX2301 given by IV, IM, or SC to see if they are safe and trigger neutralizing activity in healthy adults and adults at higher risk for severe COVID-19.

  Recruiting at 2 sites Phase 1 ModeX Therapeutics, An OPKO Health Company · Las Vegas, Nevada and 1 other locations · NCT07445971

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.