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COVID-19CARE-IF-COVIDNCT06703034

Characterization of the IFN-I Response in Subjects Who Experienced Severe or Mild Forms of COVID-19

A study testing Biological Sampling in people with COVID-19, run by Hospices Civils de Lyon at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Type I interferon (IFN-I) production is triggered by the detection of viral molecules, such as strands of viral RNA or DNA, by receptors known as PRRs (Pattern Recognition Receptors) present on many cell types. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
Biological Sampling
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
1 siteFrance
Study dates
2 Dec 2024to Jun 2028
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant aged at least 18 years
  • Previously included in the COVID-ser or NOSO-COR IMMUNO study as well as in the RNIPH study (Research Not Involving Human Persons) named MIR-COVID
  • Weight of 50 kg or more

Who cannot join

  • Current infection symptoms
  • Immunosuppression defined by: bone marrow transplant within the past 24 months, chemotherapy within the past 6 months, HIV infection with CD4 <200/mm³ or <15%, corticosteroid therapy for more than 2 weeks with a daily dose over 10 mg of prednisolone equivalent, immunosuppressive treatment administered within the previous 3 months (6 months for rituximab), aplasia, asplenia, or splenectomy
  • Pregnant, parturient, or breastfeeding woman
  • Person deprived of liberty by judicial or administrative decision
  • Person receiving psychiatric care
  • Person admitted to a health or social institution for purposes other than research
Show all 9Show fewer
  • Person under guardianship or curators
  • Person not affiliated with a social security scheme or similar coverage
  • Patient participating in another ongoing interventional research study at inclusion"

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jean-Christophe RICHARD, Pr contact

+33472011762

j-christophe.richard@chu-lyon.fr

Sophie TROUILLET-ASSANT, PhD contact

+33472678780

sophie.trouillet-assant@chu-lyon.fr

France1 site, 1 recruiting
  • Hospices Civils de Lyon - Hôpital de la Croix-Rousse

    Lyon, 69004

    Jean-Christophe RICHARD, Pr, +33 4 72 01 17 62, j-christophe.richard@chu-lyon.fr

    Jean-Christophe RICHARD, Pr

    Recruiting

Other trials in France

About this study

Type I interferon (IFN-I) production is triggered by the detection of viral molecules, such as strands of viral RNA or DNA, by receptors known as PRRs (Pattern Recognition Receptors) present on many cell types. These interferons are secreted in minimal concentrations but can activate neighboring cells to secrete over 700 proteins with antiviral properties (inhibition of viral replication, destabilization of viral membranes, etc.). Thus, the IFN-I response serves as the immune system's first line of defense during a viral infection.

Very early in the COVID-19 pandemic, several research teams, including ours, identified a defect in the type I interferon response in about one in five subjects with severe COVID-19. In-depth studies have shown that 5 to 20% of these patients with severe COVID-19 disease have genetic mutations affecting genes involved in the activation cascade of the IFN-I pathway or produce autoantibodies that neutralize IFN-I, significantly impairing the effectiveness of their IFN-I response.

Read more

However, to date, not all causes of IFN-I response alteration are clearly identified, and 80% of patients suffering from severe COVID-19 do not appear to have evident genetic predispositions or anti-IFN-I autoantibodies, with the techniques currently available. This suggests the presence of other risk factors or causes that could potentially lead to alterations in the IFN-I response.

The gut microbiota is recognized for its influence on host health and immunity. SARS-CoV-2 (Severe Acute Respiratory Syndrome CoronaVirus 2) infection has been associated with altered gut microbiota and correlated with inflammatory and immune responses. However, the association between dysbiosis and IFN-I response has yet to be studied in humans.

Therefore, to improve the management of individuals affected by viral respiratory infections, it seems essential to explore alterations in the IFN-I response to identify individuals potentially at risk of developing severe forms. It is known that a failure in the IFN-I response in the early stages of a viral infection leads to uncontrolled viral replication, which may result in a severe form of the disease. Since this IFN-I response is essential for controlling all viral infections, regardless of the virus involved, the investigators hypothesize that this IFN-I deficiency could be responsible for severe infections from various respiratory viruses that may lead to severe forms, even though a direct association between IFN-I deficiency and higher mortality risk has only been reported for a few viruses, such as SARS-CoV-2 and influenza.

Furthermore, the investigators consider the possibility of other underlying causes of IFN-I deficiencies, distinct from the already observed anti-IFN-I autoantibodies and genetic mutations. To achieve this, the investigators hypothesize that the use of functional immune tests could reveal these other alterations.

By identifying these alterations in individuals, the investigators hope to more accurately predict their propensity to develop severe forms of viral infections.

Patients who experienced :

  • mild forms of COVID-19 during the first wave, without any prior vaccination, selected from the pre-existing COVID-Ser cohort (ClinicalTrial no. NCT04341142)
  • severe forms of COVID-19 during the first wave, without any prior vaccination, selected from the pre-existing NOSO-COR IMMUNO cohort (ClinicalTrial no. NCT04637867) and the RNIPH study (Research Not Involving Human Persons) named MIR-COVID (compliance with MR004 n°20_097_v2) could be recruited.

Biological samples will be collected specifically for the study, outside of a healthcare procedure. No biological sample in biocollections coming from COVID-ser and NOSO-COR IMMUNO studies and the RNIPH study (Research Not Involving Human Persons) named MIR-COVID will be used for this new protocol.

Conditions
COVID-19
Being tested
Biological Sampling
Keywords
COVID-19, interferon, disease severity, prognosis, Immune Functional Assays
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biological SamplingOther

    The procedures specifically carried out for the study during a single visit are as follows:

    • 1 nasopharyngeal swab for the baseline measurement of the nasal IFN-I score and to check for the presence of infection
    • Blood sample collection in: o1 yellow tube (5mL) for anti-interferon antibody measurement o1 PAXgene tube (2.5mL) for the baseline IFN score without stimulation o3 green heparin tubes (12mL) for performing immune-functional tests o2 large purple tubes (20mL) for biological collection (if the patient provides specific consent) oA total of 39.5mL of venous blood will be collected for the study during a single visit.
    • Stool collection at home by the patient, to be sent by mail to the Biological Resource Center (CRB) of the Hospices Civils de Lyon (HCL) within 10 days after the visit.
    • A food frequency questionnaire composed of 159 items measuring the frequency of consumption of foods and drinks over the past 12 months to complement the analysis of the gut microbiota.
Study groups in NCT06703034
Study groupRoleWhat they receive
Mild patientsOtherPatients who experienced mild forms of COVID-19 during the first wave, without any prior vaccination, selected from the pre-existing COVID-Ser cohort (ClinicalTrial no. NCT04341142).
Receives: Other: Biological Sampling
Severe patientsOtherPatients who experienced severe forms of COVID-19 during the first wave, without any prior vaccination, selected from the pre-existing NOSO-COR IMMUNO cohort (ClinicalTrial no. NCT04637867) and the RNIPH study (Research Not Involving Human Persons) named MIR-COVID.
Receives: Other: Biological Sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. IFN-I score measured post-stimulation by Influenza A virus (IAV) in vitro

    Comparison of the score IFN-I, measured by assessing the expression of a selection of IFN-I-stimulated genes, between the two groups of interest (mild or severe form).

    Given the limited advancement of studies on the interferon score following stimulation, no scoring scale is currently established. However, an increase in the score would be associated with a functional response to stimulation, indicating the absence of alterations in the targeted interferon induction pathway.

    Measured: At inclusion visit (Day 0)

Secondary outcomes (15)
  1. IFN-I response induced post-stimulation in vitro by Poly I

    Comparison of the score IFN-I, measured by assessing the expression of a selection of IFN-I-stimulated genes, between the two groups of interest (mild or severe form).

    Given the limited advancement of studies on the interferon score following stimulation, no scoring scale is currently established. However, an increase in the score would be associated with a functional response to stimulation, indicating the absence of alterations in the targeted interferon induction pathway.

    Measured: At inclusion visit (Day 0)

  2. Induction of immune pathways post-stimulation at a transcriptomic/proteomic level on a panel of genes and cytokines/chemokines specifically involved in key processes of the immune response

    Comparison of gene expression levels, fold-changes expression, activation levels (Z-scores, p-value, FDR), and comparison of the concentrations of secreted cytokines/chemokines between the 2 groups of interest (mild or severe form)

    Measured: At inclusion visit (Day 0)

  3. Presence of anti-IFN-I autoantibodies

    Comparison of the presence and levels of anti-IFN-I autoantibodies between the two groups

    Measured: At inclusion visit (Day 0)

  4. Presence of other serum anti-cytokine autoantibodies detected by multiplex ELISA (Infinity Biomarker)

    Comparison of the presence and levels of other serum anti-cytokine antibodies between the two groups (mild or severe form)

    Measured: At inclusion visit (Day 0)

  5. Presence of genetic mutations affecting antiviral immune pathways

    Comparison of the frequency of genetic mutations affecting genes involved in the IFN-I response detected by sequencing between the two groups (mild or severe form)

    Measured: At inclusion visit (Day 0)

  6. Comparison of the blood and nasal IFN score in vivo without stimulation to the blood IFN score post-stimulation in vitro by the live attenuated Influenza A virus (IAV).

    Comparison of the blood and nasal IFN score in vivo without stimulation and the blood IFN score post-stimulation in vitro by the live attenuated Influenza A virus (IAV), Poly I:C, resiquimod (R848), diABZI, and IFNα

    Measured: At inclusion visit (Day 0)

  7. Propensity of individuals with a low IFN score post-stimulation by IAV to develop severe viral infections in the two winters following inclusion

    Correlation of the IFN score post-stimulation by IAV with severe infectious episodes during the two winters following inclusion

    Measured: After 2 winters (at last month 18)

  8. Overall composition of the gut microbiota and possibly the metabolome, depending on the intensity of the functional immune response post-stimulation.

    Correlation between the composition of the gut microbiota and possibly the metabolome and the immune response post-stimulation

    Measured: At inclusion visit (Day 0)

  9. IFN-I response induced post-stimulation in vitro by resiquimod (R848)

    Comparison of the score IFN-I, measured by assessing the expression of a selection of IFN-I-stimulated genes, between the two groups of interest (mild or severe form)

    Measured: At inclusion visit (Day 0)

  10. IFN-I response induced post-stimulation in vitro by diABZI

    Comparison of the score IFN-I, measured by assessing the expression of a selection of IFN-I-stimulated genes, between the two groups of interest (mild or severe form)

    Measured: At inclusion visit (Day 0)

  11. IFN-I response induced post-stimulation in vitro by IFNα

    Comparison of the score IFN-I, measured by assessing the expression of a selection of IFN-I-stimulated genes, between the two groups of interest (mild or severe form)

    Measured: At inclusion visit (Day 0)

  12. Comparison of the blood and nasal IFN score in vivo without stimulation to the blood IFN score post-stimulation in vitro by Poly I:C

    Comparison of the blood and nasal IFN score in vivo without stimulation and the blood IFN score post-stimulation in vitro by the live attenuated Influenza A virus (IAV), Poly I:C, resiquimod (R848), diABZI, and IFNα

    Measured: At inclusion visit (Day 0)

  13. Comparison of the blood and nasal IFN score in vivo without stimulation to the blood IFN score post-stimulation in vitro by resiquimod (R848)

    Comparison of the blood and nasal IFN score in vivo without stimulation and the blood IFN score post-stimulation in vitro by the live attenuated Influenza A virus (IAV), Poly I:C, resiquimod (R848), diABZI, and IFNα

    Measured: At inclusion visit (Day 0)

  14. Comparison of the blood and nasal IFN score in vivo without stimulation to the blood IFN score post-stimulation in vitro by diABZI

    Comparison of the blood and nasal IFN score in vivo without stimulation and the blood IFN score post-stimulation in vitro by the live attenuated Influenza A virus (IAV), Poly I:C, resiquimod (R848), diABZI, and IFNα

    Measured: At inclusion visit (Day 0)

  15. Comparison of the blood and nasal IFN score in vivo without stimulation to the blood IFN score post-stimulation in vitro by IFNα

    Comparison of the blood and nasal IFN score in vivo without stimulation and the blood IFN score post-stimulation in vitro by the live attenuated Influenza A virus (IAV), Poly I:C, resiquimod (R848), diABZI, and IFNα

    Measured: At inclusion visit (Day 0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2024
  2. Study start2 Dec 2024
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
This is a single-center, comparative, prospective, interventional study with minimal risk and constraints, RIPH category 2 outside of healthcare product
Masking
None (open label)
Enrolment
134 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06703034
Sponsor's protocol ID
69HCL24_0703
Other IDs
2024-A01750-47
Acronym
CARE-IF-COVID
Status last verified
Jun 2026
First submitted
21 Nov 2024
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Biological Sampling in people with COVID-19, run by Hospices Civils de Lyon 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 3 inclusion and 9 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 9 Jun 2026. 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 Jean-Christophe RICHARD, Pr (+33472011762, j-christophe.richard@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IFN-I score measured post-stimulation by Influenza A virus (IAV) in vitro (time frame: At inclusion visit (Day 0)). 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 9 Jun 2026.

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CARE-IF-COVID Clinical Trial NCT06703034 | AzTrials