Severe Respiratory InfectionsINTERFERICUSNCT05536219
Impact of the Presence of Anti-interferon Autoantibodies on the Viral Load in Severe Respiratory Infections
An observational study of Severe Respiratory Infections, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
Type I interferons (IFN-I) production is induced by the detection of viral molecules, such as RNA or DNA viral strands, through pattern recognition receptors (PRR) present on many immune cell types. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Respiratory Infections
- What is being tested?
- Serum anti-IFN-I antibodies
- How many people
- 360 participants
- Where
- 3 sitesFrance
- Study dates
- 8 Nov 2022to 8 Aug 2027
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients and pediatric patients admitted to intensive care unit with acute respiratory failure induced by RSV, influenza or SARS-Cov-2 viral infection (for adults only) or in respiratory distress placed on oxygen with suggestive sign(s) of viral infection for minors only.
Who may be able to join
- For adult patients :
- Patients with acute respiratory failure requiring the administration of oxygen* to maintain peripheral oxygen saturation at at least 90%
- in patients with chronic respiratory failure, an oxygen flow higher than the usual flow or a duration of non-invasive ventilation longer than the usual duration will be required.
- Patients with influenza, RSV or SARS-CoV-2 infection diagnosed by Reverse Transcription Polymerase Chain Reaction (RT-PCR) or antigen test in the last 7 days
- Patients hospitalized in participating intensive care units
- For pediatric patient :
Show all 12Show fewer
- In respiratory distress placed on oxygen with signs suggestive of viral infection:
- moderate or absent fever or nasopharyngeal congestion or cough
- signs of acute respiratory distress (polypnea > 2DS of the normal value, intercostal drawing, thoraco-abdominal sway) with more or less marked hypoxia (SpO2 < 92% under ambient air),
- and/or significant apnea (associated with bradycardia or desaturation),
- and/or dietary difficulties (reduction of rations to less than 50% of the usual ration).
- Hospitalized in the pediatric emergency and intensive care unit of Hôpital Femme Mère Enfant (HFME)
Who cannot join
- Opposition of the patient or his close family/friend to inclusion in the study
- Patient under legal protection measure
- Patient who was included in this study during a previous stay
- Immunodepression defined by: bone marrow allograft less than 24 months old, chemotherapy for less than 6 months, HIV infection with CD4<200/mm3 or <15%, corticosteroid therapy for more than 2 weeks with a daily dose greater than 10 mg of prednisolone equivalent, immunosuppressive treatment administered in the previous 3 months (6 months for rituximab), aplasia, asplenia or splenectomy.
- Patient under 30 kg (for adults) and less than 3 kg (for children)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Hôpital Femme Mère et enfant
Bron, Rhone, 69500
Etienne Javouhey, MD, 04 27 85 61 56 ext. +33, etienne.javouhey@chu-lyon.fr
- Recruiting
Hôpital Croix Rousse
Lyon, Rhône, 69004
Louis CHAUVELOT, MD, 04 72 07 17 62 ext. +33, louis.chauvelot@chu-lyon.fr
LOUIS chauvelot, MD
- Recruiting
Hopital Lyon Sud
Pierre-Bénite, Rhone, 69110
FLORENT WALLET, 0478861921 ext. +33, florent.wallet@chu-lyon.fr
FLORENT WALLET, MD
About this study
Official title: Impact of the Presence of Anti-interferon Autoantibodies on the Viral Load in Severe Respiratory Infections in Intensive Care
Type I interferons (IFN-I) production is induced by the detection of viral molecules, such as RNA or DNA viral strands, through pattern recognition receptors (PRR) present on many immune cell types. Despite a minimal concentration, IFN-I secretion activate the secretion, by neighbouring cells, of more than 700 proteins with antiviral properties (inhibition of viral replication, destabilization of virus membranes, etc.). IFN-I constitute therefore one of the major first line of defence established by the immune system in response to viral infection. Briefly, during the Coronavirus disease (COVID-19) pandemic, several teams including ours, highlighted a lack of IFN-I response in approximately one in five individuals presenting a severe form of COVID-19.
Interestingly, within a large part of them, in vitro investigations revealed the presence of autoantibodies presenting neutralizing capacities against alpha and/or omega interferons This finding confirms the deleterious role of anti-IFN-I autoantibodies on the antiviral immune response and the key role of IFN-I pathway regarding defences against COVID-19 infection. Furthermore, those observations pave the way to interesting research that would allow understanding the underlying pathophysiological mechanisms of severe viral respiratory infection.
Read more
The research hypothesis are:
- IFN-I deficiency could induce severe forms of viral infections which could lead to intensive care admission ii) IFN-I deficiency could increase viral loads in nasopharyngeal samples, and be associated with protracted viral clearance iii) The frequency of viral co-infections may be higher in case of IFN-I antiviral pathway blockade, iv) severe forms of respiratory viruses' infections could be induced by other anti-cytokine autoantibodies.
In addition to confirming research hypotheses recently mentioned, the aim of this clinical protocol will be to assess the impact of antiviral innate immune response alterations in severe respiratory infections.
- Conditions
- Severe Respiratory Infections
- Being tested
- Serum anti-IFN-I antibodies
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum anti-IFN-I antibodiesDiagnostic test
Anti-IFN-I autoantibodies presence will be assessed through serological methods (ThermoFisher Kit)
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in viral load in nasopharyngeal samples for adult patients
Main outcome will be the difference of viral load (expressed in log copies per million cells) at D0±1 day and D7±1 day post inclusion (presence or absence of anti-IFN-I autoantibodies), and stratified by pathogen (influenza, respiratory syncytial virus (RSV), COVID-19).
Measured: At Day 0 and Day 7
Change in viral load in nasopharyngeal samples for pediatric patients
Main outcome will be the prevalence of anti-interferon antibodies presence (expressed in log copies per million cells) at Day 0 and Day 7 post inclusion and to compare the respiratory co-infections frequency.
Measured: At Day 0 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start8 Nov 2022
- Primary completion8 Aug 2027 (estimated)
- Study completion8 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Respiratory InfectionsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536219
- Sponsor's protocol ID
- 69HCL22_0674
- Acronym
- INTERFERICUS
- Status last verified
- Sep 2025
- First submitted
- 7 Sep 2022
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Presence of Anti-interferon Autoantibodies on the Viral Load in Severe Respiratory Infections in Intensive Care
- ClinicalTrials.gov ID
- NCT05536219
- Acronym / sponsor ID
- INTERFERICUS / 69HCL22_0674
- Conditions
- Severe Respiratory Infections
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 8 Aug 2027 (estimated)
- Study completion
- 8 Aug 2027 (estimated)
- First posted
- 10 Sep 2022 (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.
Type I interferons (IFN-I) production is induced by the detection of viral molecules, such as RNA or DNA viral strands, through pattern recognition receptors (PRR) present on many immune cell types. Despite a minimal concentration, IFN-I secretion activate the secretion, by neighbouring cells, of more than 700 proteins with antiviral properties (inhibition of viral replication, destabilization of virus membranes, etc.). IFN-I constitute therefore one of the major first line of defence established by the immune system in response to viral infection. Briefly, during the Coronavirus disease (COVID-19) pandemic, several teams including ours, highlighted a lack of IFN-I response in approximately one in five individuals presenting a severe form of COVID-19.
Interestingly, within a large part of them, in vitro investigations revealed the presence of autoantibodies presenting neutralizing capacities against alpha and/or omega interferons This finding confirms the deleterious role of anti-IFN-I autoantibodies on the antiviral immune response and the key role of IFN-I pathway regarding defences against COVID-19 infection. Furthermore, those observations pave the way to interesting research that would allow understanding the underlying pathophysiological mechanisms of severe viral respiratory infection.
The research hypothesis are:
- IFN-I deficiency could induce severe forms of viral infections which could lead to intensive care admission ii) IFN-I deficiency could increase viral loads in nasopharyngeal samples, and be associated with protracted viral clearance iii) The frequency of viral co-infections may be higher in case of IFN-I antiviral pathway blockade, iv) severe forms of respiratory viruses' infections could be induced by other anti-cytokine autoantibodies.
In addition to confirming research hypotheses recently mentioned, the aim of this clinical protocol will be to assess the impact of antiviral innate immune response alterations in severe respiratory infections.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients and pediatric patients admitted to intensive care unit with acute respiratory failure induced by RSV, influenza or SARS-Cov-2 viral infection (for adults only) or in respiratory distress placed on oxygen with suggestive sign(s) of viral infection for minors only.
Key inclusion criteria (12 listed)
- Patients with acute respiratory failure requiring the administration of oxygen* to maintain peripheral oxygen saturation at at least 90%
- Patients with influenza, RSV or SARS-CoV-2 infection diagnosed by Reverse Transcription Polymerase Chain Reaction (RT-PCR) or antigen test in the last 7 days
- Patients hospitalized in participating intensive care units
- In respiratory distress placed on oxygen with signs suggestive of viral infection:
- Hospitalized in the pediatric emergency and intensive care unit of Hôpital Femme Mère Enfant (HFME)
Key exclusion criteria (5 listed)
- Opposition of the patient or his close family/friend to inclusion in the study
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 |
|---|---|---|
| Serum anti-IFN-I antibodiesAnti-IFN-I autoantibodies presence will be assessed through serological methods (ThermoFisher Kit) | Diagnostic test | – |
Primary outcome
Change in viral load in nasopharyngeal samples for adult patients
Time frame: At Day 0 and Day 7
Main outcome will be the difference of viral load (expressed in log copies per million cells) at D0±1 day and D7±1 day post inclusion (presence or absence of anti-IFN-I autoantibodies), and stratified by pathogen (influenza, respiratory syncytial virus (RSV), COVID-19).
Change in viral load in nasopharyngeal samples for pediatric patients
Time frame: At Day 0 and Day 7
Main outcome will be the prevalence of anti-interferon antibodies presence (expressed in log copies per million cells) at Day 0 and Day 7 post inclusion and to compare the respiratory co-infections frequency.
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 25 Sep 2025.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Respiratory Infections, run by Hospices Civils de Lyon at 3 sites 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 5 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 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Louis CHAUVELOT, MD (0472071762 ext. +33, louis.chauvelot@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in viral load in nasopharyngeal samples for adult patients (time frame: At Day 0 and Day 7). The study lists 2 primary outcomes in all. 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 25 Sep 2025.