Pronostic Value of Type I ANTi-Interferon Antibodies in Patients With COVID-19 Acute Respiratory Failure

Study Overview
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Brief Summary
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Severe SARS-CoV-2 infections are frequently associated with the acute respiratory distress syndrome (ARDS), which leads to a mortality of 30-40%. An altered type I interferon (IFN) response has been demonstrated in patients with severe COVID-19, together with a high viral load. The aim of the current work is, in a large cohort of patients with severe COVID-19 admitted in the ICU, to determine the prevalence of patients with positive anti-IFN antibodies and to determine their outcome, as compared to patients having negative anti-IFN antibodies.

Detailed Description
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Severe SARS-CoV-2 infections are frequently associated with the acute respiratory distress syndrome (ARDS), which leads to a mortality of 30-40%. An altered type I interferon (IFN) response has been demonstrated in patients with severe COVID-19, together with a high viral load. A recent study revealed that 10% of patients admitted in the intensive care unit (ICU) for severe COVID-19 had positive type I anti-IFN antibodies. Such finding has potentially important therapeutic implications, as patients having positive anti-IFN antibodies could benefit from targeted interventions, including plasmapheresis. The aim of the current work is, in a large cohort of patients with severe COVID-19 admitted in the ICU, to determine the prevalence of patients with positive anti-IFN antibodies and to determine their outcome, as compared to patients having negative anti-IFN antibodies.

Official Title
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Pronostic Value of Type I ANTi-Interferon Antibodies in Patients With COVID-19 Acute Respiratory Failure: a Multicenter Observational Study

Conditions
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Acute Respiratory Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years SARS-CoV-2 infection with a positive PCR Patient admitted in the ICU for acute respiratory failure (SpO2≤90% and need for supplemental oxygen or any kind of ventilator support) Patient or next of keen was informed of study inclusion Exclusion Criteria: • Patient with SARS-CoV-infection but no acute respiratory failure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| day-28 mortality | comparaison of day-28 mortality in patients having positive versus negative type I anti-IFN antibodies | at day-28 of intensive care unit (ICU) admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of positivity of type I anti-IFN antibodies | positivity of type I anti-IFN antibodies measured on a serum sample obtained at any time during ICU stay | 3 months of ICU admission | 
| Factors associated with type I anti-IFN antibody positivity | Factors associated with type I anti-IFN antibody positivity available upon hospital admission, identified using uni- and multiple logistic regression analyses | 24 hours of ICU admission | 
| hospital mortality | Comparaison of hospital mortality of patients having positive versus negative type I anti-IFN antibodies | at day 90. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Acute respiratory failure, ARDS