COVID-19COVARIANTNCT05858502
Understanding the Determinants of Mucosal Immunity and Optimizing the Diagnosis of Infection With SARS-CoV-2 Variants
A study testing Blood sample collection, Saliva sample collection and Nasopharyngeal and nasal sample collection in people with COVID-19, run by Institut Pasteur at 1 site in France.
Trial summary
One of the current health challenges in the face of the COVID-19 pandemic that started in Wuhan in 2019, and still responsible for successive waves, is to better understand and diagnose the infection. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Blood sample collection, Saliva sample collection and Nasopharyngeal and nasal sample collection
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2023to 18 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Pasteur - ICAReB-clin
Paris, 75015
Hélène Laude, MD, helene.laude@pasteur.fr
About this study
One of the current health challenges in the face of the COVID-19 pandemic that started in Wuhan in 2019, and still responsible for successive waves, is to better understand and diagnose the infection.
The new variants - delta, then omicron, which appeared in November 2021 and then their sub-variants BA.2, then BA.4 and 5, and more recently BQ.1 and the sub-variant XBB.1.5 are increasingly transmissible and responsible for some degree of immune escape. Hence the importance of a better understanding of infection- or vaccine-induced immunity in order to optimize existing prophylactic or therapeutic strategies, or even to develop new, more effective ones.
Read more
Mucosal immunity could play a particularly important role in interrupting the infection cycle at the entry point of the virus.
The key role of innate immunity has been demonstrated in particular, via interferons and the composition of the microbiota.
Humoral immunity is the best documented. However, it tends to be eroded within a few months. On the other hand, cellular immunity is more stable over time and would largely explain the decrease in severe forms of the disease in vaccinated individuals.
The collection of biological resources that will be built up during this study will also allow us to optimize or develop new diagnostic methods, necessary as a complement to vaccination, to effectively slow down the spread of the pandemic and reduce the severity of its impact on the population.
The improvement of diagnostic methods will in turn improve the understanding of the infection by providing increasingly reliable information on the characteristics of an infection, its quantification, its dynamics, and its resolution, especially since these parameters will be compared, at any time during the study, with reference methods and the immunological status of the subject.
The main significant improvements expected in the field of SARS-CoV-2 diagnosis are notably the improvement of performance (reduction of false negatives in RT-PCR on nasopharyngeal samples), acceptability, simplicity of implementation in the field, and the capacity to test transmission.
The objective of this study is to identify and characterize SARS-CoV-2 infection and host response, particularly mucosal immunity.
Read the detailed description
This is a prospective, longitudinal, descriptive study that will include adult participants infected and uninfected with Sars-CoV-2 at the time of recruitment.
Participants will be divided into 3 groups of 30 evaluable subjects:
- uninfected,
- asymptomatically infected,
- symptomatically infected.
The participants will be identified within the Ile-de-France medical analysis laboratories partners of the project.
Study with sample collection:
- For participants infected with SARS-CoV-2: Inclusion visit V0, ≤ 3 days after PCR test Follow-up visit V1, 7 d ± 1 d after V0 Follow-up visit V2, 31 d ± 2 d after V0 V3 follow-up visit, 91 d ± 5 d after V0
- For participants not infected with SARS-CoV-2 : Inclusion visit V0, ≤ 3 days after PCR test V1' visit, no more than 96 d after V0.
- Conditions
- COVID-19
- Being tested
- Blood sample collection, Saliva sample collection, Nasopharyngeal and nasal sample collection, Exhaled Breath Condensate (EBC)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionBiological
Blood sample collection between inclusion and 3 months max 55 ml at each visit
Saliva sample collectionOther
Saliva sample collection between inclusion and 3 months
Nasopharyngeal and nasal sample collectionOther
Nasopharyngeal and nasal sample collection between inclusion and 3 months
Exhaled Breath Condensate (EBC)Other
Exhaled Breath Condensate (EBC) between inclusion and 3 months
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize SARS-CoV-2 infection and host response, particularly mucosal immunity.
Measurement of mucosal anti-SARS-CoV-2 antibody levels and cytokines, composition of the local microbiota of the upper respiratory tract.
Measured: 12 months
Secondary outcomes (5)
To characterize biomarkers of infection (stage, severity, prognosis) with new innovative direct or indirect diagnostic methods for SARS-CoV-2 and identify potential theranostic biomarkers.
Measurement of the capacity of the biomarkers to characterize the different stages, severity and prognosis of the infection, or theranostic potential.
Measured: 12 months
To characterize the dynamics of infection and immunological response from the date of suspected infection and up to 3 months post-infection, or later, during the first year
Kinetics of virological evolution and immune response in different compartments (blood, upper and lower respiratory)
Measured: 12 months
To develop tools to assess the contamination capacity of subjects.
Measurement of viral load in exhaled air condensates
Measured: 12 months
To characterization of mucosal and humoral immunity.
Measurement and comparison of mucosal and humoral immunity parameters
Measured: 12 months
To optimize sampling techniques and calibrate the detection of viral components by artificial contamination on samples taken during the 1st visit of uninfected subjects.
Measurement of viral detection calibration results on the 1st visit samples of uninfected subjects
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start15 Dec 2023
- Primary completion15 Mar 2026 (estimated)
- Study completion18 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biogroup Laboratoire de biologie médicale
- Responsible party
- Sponsor
- Investigators
- Hélène Laude, MD, Principal investigator, Institut Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858502
- Sponsor's protocol ID
- 2021-079
- Other IDs
- 2022-A02703-40
- Acronym
- COVARIANT
- Status last verified
- May 2025
- First submitted
- 12 May 2023
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Determinants of Mucosal Immunity and Optimizing the Diagnosis of Infection With SARS-CoV-2 Variants
- ClinicalTrials.gov ID
- NCT05858502
- Acronym / sponsor ID
- COVARIANT / 2021-079
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Biogroup Laboratoire de biologie médicale
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 18 Jun 2026 (estimated)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One of the current health challenges in the face of the COVID-19 pandemic that started in Wuhan in 2019, and still responsible for successive waves, is to better understand and diagnose the infection.
The new variants - delta, then omicron, which appeared in November 2021 and then their sub-variants BA.2, then BA.4 and 5, and more recently BQ.1 and the sub-variant XBB.1.5 are increasingly transmissible and responsible for some degree of immune escape. Hence the importance of a better understanding of infection- or vaccine-induced immunity in order to optimize existing prophylactic or therapeutic strategies, or even to develop new, more effective ones.
Mucosal immunity could play a particularly important role in interrupting the infection cycle at the entry point of the virus.
The key role of innate immunity has been demonstrated in particular, via interferons and the composition of the microbiota.
Humoral immunity is the best documented. However, it tends to be eroded within a few months. On the other hand, cellular immunity is more stable over time and would largely explain the decrease in severe forms of the disease in vaccinated individuals.
The collection of biological resources that will be built up during this study will also allow us to optimize or develop new diagnostic methods, necessary as a complement to vaccination, to effectively slow down the spread of the pandemic and reduce the severity of its impact on the population.
The improvement of diagnostic methods will in turn improve the understanding of the infection by providing increasingly reliable information on the characteristics of an infection, its quantification, its dynamics, and its resolution, especially since these parameters will be compared, at any time during the study, with reference methods and the immunological status of the subject.
The main significant improvements expected in the field of SARS-CoV-2 diagnosis are notably the improvement of performance (reduction of false negatives in RT-PCR on nasopharyngeal samples), acceptability, simplicity of implementation in the field, and the capacity to test transmission.
The objective of this study is to identify and characterize SARS-CoV-2 infection and host response, particularly mucosal immunity.
Detailed description
This is a prospective, longitudinal, descriptive study that will include adult participants infected and uninfected with Sars-CoV-2 at the time of recruitment.
Participants will be divided into 3 groups of 30 evaluable subjects:
- uninfected,
- asymptomatically infected,
- symptomatically infected.
The participants will be identified within the Ile-de-France medical analysis laboratories partners of the project.
Study with sample collection:
- For participants infected with SARS-CoV-2: Inclusion visit V0, ≤ 3 days after PCR test Follow-up visit V1, 7 d ± 1 d after V0 Follow-up visit V2, 31 d ± 2 d after V0 V3 follow-up visit, 91 d ± 5 d after V0
- For participants not infected with SARS-CoV-2 : Inclusion visit V0, ≤ 3 days after PCR test V1' visit, no more than 96 d after V0.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Common criteria for all subjects:
- Criteria for the SARS-CoV-2 infected participant group:
- Criteria for the SARS-CoV-2 uninfected group:
Key exclusion criteria (12 listed)
- Criteria common to all subjects :
- SARS-CoV-2 infected participant group criteria:
- SARS-CoV-2 uninfected participant group criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collectionBlood sample collection between inclusion and 3 months max 55 ml at each visit | Biological | – |
| Saliva sample collectionSaliva sample collection between inclusion and 3 months | Other | – |
| Nasopharyngeal and nasal sample collectionNasopharyngeal and nasal sample collection between inclusion and 3 months | Other | – |
| Exhaled Breath Condensate (EBC)Exhaled Breath Condensate (EBC) between inclusion and 3 months | Other | – |
Primary outcome
To characterize SARS-CoV-2 infection and host response, particularly mucosal immunity.
Time frame: 12 months
Measurement of mucosal anti-SARS-CoV-2 antibody levels and cytokines, composition of the local microbiota of the upper respiratory tract.
5 secondary outcomes
To characterize biomarkers of infection (stage, severity, prognosis) with new innovative direct or indirect diagnostic methods for SARS-CoV-2 and identify potential theranostic biomarkers.
Time frame: 12 months
To characterize the dynamics of infection and immunological response from the date of suspected infection and up to 3 months post-infection, or later, during the first year
Time frame: 12 months
To develop tools to assess the contamination capacity of subjects.
Time frame: 12 months
To characterization of mucosal and humoral immunity.
Time frame: 12 months
To optimize sampling techniques and calibrate the detection of viral components by artificial contamination on samples taken during the 1st visit of uninfected subjects.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hélène Laude, MD principal investigator
Institut Pasteur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample collection, Saliva sample collection and Nasopharyngeal and nasal sample collection in people with COVID-19, run by Institut Pasteur at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hélène Laude, MD (33145688394, helene.laude@pasteur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize SARS-CoV-2 infection and host response, particularly mucosal immunity. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.