Clinical trial NCT04733105: Pronostic Value of Type I ANTi-Interferon Antibodies in Patients With COVID-19 Acute Respiratory Failure
Official title: Pronostic Value of Type I ANTi-Interferon Antibodies in Patients With COVID-19 Acute Respiratory Failure: a Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Failure
Keywords: COVID-19
Acute respiratory failure
ARDS
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 1022
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with proven SARS-CoV-2 infection and acute respiratory failure admitted in the intensive care unit

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: day-28 mortality
timeFrame: at day-28 of intensive care unit (ICU) admission
Secondary outcomes:
measure: rate of positivity of type I anti-IFN antibodies
timeFrame: 3 months of ICU admission
measure: Factors associated with type I anti-IFN antibody positivity
timeFrame: 24 hours of ICU admission
measure: hospital mortality
timeFrame: at day 90.
Other outcomes:
Locations:
city: Créteil
country: France
facility: Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Study officials:
affiliation: APHP
name: Nicolas De PROST, MD, PhD
role: STUDY_CHAIR
References: