Impact of anti-interferon autoantibodies on viral load in severe respiratory infections

Impact of the Presence of Anti-interferon Autoantibodies on the Viral Load in Severe Respiratory Infections in Intensive Care

This study is testing how certain antibodies in the blood might affect the amount of virus in patients of all ages who are seriously ill with respiratory infections like influenza, RSV, or COVID-19 and need oxygen support.

Quick facts

• Study type: Observational
• Enrollment: 360 (estimated)
• Sex: All
• Sponsor: Hospices Civils de Lyon (Academic / other)
• Drugs / interventions: rituximab, chemotherapy
• Locations: 3 sites (Bron, Rhone and 2 other locations)
• Trial ID: NCT05536219 on ClinicalTrials.gov

What this trial studies

This observational study investigates the role of anti-interferon autoantibodies in patients suffering from severe respiratory infections, particularly focusing on their impact on viral load. It aims to analyze serum samples from adult and pediatric patients diagnosed with influenza, RSV, or SARS-CoV-2 infections who require oxygen support. By understanding the relationship between these autoantibodies and viral response, the study seeks to shed light on potential immune deficiencies in severe cases. The findings could help identify patients at risk for poor outcomes due to impaired interferon responses.

Who should consider this trial

Good fit: Ideal candidates include adults and children with acute respiratory failure due to viral infections requiring oxygen support.

Not a fit: Patients with mild respiratory infections or those not requiring oxygen support may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of severe respiratory infections, potentially guiding targeted therapies.

How similar studies have performed: While the role of interferons in viral infections has been studied, the specific focus on anti-interferon autoantibodies in severe respiratory infections is relatively novel.

Eligibility criteria

Inclusion Criteria:

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 :

* In respiratory distress placed on oxygen with signs suggestive of viral infection:

  1. moderate or absent fever or nasopharyngeal congestion or cough
  2. 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),
  3. and/or significant apnea (associated with bradycardia or desaturation),
  4. 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)

Exclusion Criteria:

* 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)

Where this trial is running

Bron, Rhone and 2 other locations

• Hôpital Femme Mère et enfant — Bron, Rhone, France (Recruiting)
• Hopital Lyon Sud — Pierre-Bénite, Rhone, France (Recruiting)
• Hôpital Croix Rousse — Lyon, Rhône, France (Recruiting)

Study contacts

• Study coordinator: Louis CHAUVELOT, MD

Conditions Severe Respiratory Infections